<?xml version="1.0" encoding="UTF-8"?><rss xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:atom="http://www.w3.org/2005/Atom" version="2.0" xmlns:itunes="http://www.itunes.com/dtds/podcast-1.0.dtd" xmlns:googleplay="http://www.google.com/schemas/play-podcasts/1.0"><channel><title><![CDATA[GLP-1 Studio: Policy]]></title><description><![CDATA[The Patient Lens from GLP1Laws — what a bill, lawsuit, FDA action or coverage decision actually means for patients.]]></description><link>https://newsletter.glp1studio.com/s/laws</link><image><url>https://substackcdn.com/image/fetch/$s_!yJhR!,w_256,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F48bdba6e-b8a2-44bc-9fe4-8a5403cc8ba3_1254x1254.png</url><title>GLP-1 Studio: Policy</title><link>https://newsletter.glp1studio.com/s/laws</link></image><generator>Substack</generator><lastBuildDate>Thu, 22 Oct 2026 11:32:02 GMT</lastBuildDate><atom:link href="https://newsletter.glp1studio.com/feed" rel="self" type="application/rss+xml"/><copyright><![CDATA[GLP-1 Studio LLC]]></copyright><language><![CDATA[en]]></language><webMaster><![CDATA[media@glp1studio.com]]></webMaster><itunes:owner><itunes:email><![CDATA[media@glp1studio.com]]></itunes:email><itunes:name><![CDATA[Amanda Bonello]]></itunes:name></itunes:owner><itunes:author><![CDATA[Amanda Bonello]]></itunes:author><googleplay:owner><![CDATA[media@glp1studio.com]]></googleplay:owner><googleplay:email><![CDATA[media@glp1studio.com]]></googleplay:email><googleplay:author><![CDATA[Amanda Bonello]]></googleplay:author><itunes:block><![CDATA[Yes]]></itunes:block><item><title><![CDATA[High-dose semaglutide starts are linked to earlier discontinuation]]></title><description><![CDATA[A real-world cohort study found that starting injectable semaglutide at high doses is associated with earlier discontinuation and decreased 1-year persistence.]]></description><link>https://newsletter.glp1studio.com/p/high-dose-semaglutide-starts-are</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/high-dose-semaglutide-starts-are</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Wed, 21 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/97e23efe-7b56-48f0-a8be-582f2b0903fe_1880x1253.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/woman-holding-botox-flask-15688019/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!iPGO!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F97e23efe-7b56-48f0-a8be-582f2b0903fe_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!iPGO!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F97e23efe-7b56-48f0-a8be-582f2b0903fe_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!iPGO!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F97e23efe-7b56-48f0-a8be-582f2b0903fe_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!iPGO!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F97e23efe-7b56-48f0-a8be-582f2b0903fe_1880x1253.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!iPGO!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F97e23efe-7b56-48f0-a8be-582f2b0903fe_1880x1253.jpeg" width="1456" height="970" 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20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by Jonathan Borba on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>CMS proposed a rule on Oct 20, 2026 addressing Medicare Part D cost-sharing reductions, provider lists and PBM accountability, with comments due Dec 15, 2026.</h6></li><li><h6>EMA updated Victoza's EU product information on October 16, 2026, under its type 2 diabetes indication.</h6></li><li><h6>A new preprint, not yet peer reviewed, found semaglutide initiation was associated with higher heart rate during sleep, most during REM sleep, unexplained by weight loss.</h6></li><li><h6>A cohort study linked high-dose semaglutide starts to earlier discontinuation and decreased 1-year persistence.</h6></li></ul></div><p>This roundup covers a general Medicare proposed rule, an update to a European product information record, and new research on semaglutide. None of it changes what is approved or available, but it adds details that patients and prescribers may find useful. If you use a GLP-1 drug, or help someone who does, these updates are worth a few minutes of your time.</p><p>The Centers for Medicare &amp; Medicaid Services proposed a rule on October 20, 2026, to carry out three sections of the Consolidated Appropriations Act, 2026. The rule covers adjustments to Medicare Part D cost-sharing reductions for low-income individuals, a requirement for more accurate lists of health providers, and new accountability rules for pharmacy benefit managers. The proposal does not mention GLP-1 drugs. It is a proposed rule, not a final one, so nothing is settled yet. Public comments are open through December 15, 2026.</p><p>The European Medicines Agency updated Victoza's EU product information on October 16, 2026, under procedure VR/0000362001. Victoza, Novo Nordisk's liraglutide brand, has been authorized in the EU since June 30, 2009, for adults, adolescents, and children aged 10 and older with insufficiently controlled type 2 diabetes who need it alongside diet and exercise. This update only touches the product information tied to that existing authorization. It does not represent a new approval or a new use for the drug.</p><p>A new preprint, listed October 20, 2026, and not yet peer reviewed, looked at heart rate patterns after people started semaglutide. The researchers found semaglutide initiation was associated with higher heart rate throughout sleep, most during REM sleep, and this was not explained by weight loss. The authors also noted that clinic measurements may understate the effect. Because this is a preprint, it has not gone through peer review, so the findings have not yet been vetted by outside researchers.</p><p>A cohort study published in Diabetes, Obesity and Metabolism on October 19, 2026, looked at real-world patterns of starting injectable semaglutide in the United States. It found that starting at high doses is common in practice, and that high-dose initiation is associated with earlier discontinuation and decreased 1-year persistence. The study describes high-dose initiation as a modifiable risk factor. This is a cohort study, not a randomized trial, so it shows an association rather than a proven cause.</p><p>Reading the original documents directly is the best way to see exactly what each one says and does not say. Nothing here tells you what to do, but it does show what regulators and researchers are currently looking at.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-21">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[Lilly registers two EloraTZP obesity trials, results years away]]></title><description><![CDATA[Both obesity studies are not yet recruiting, with completion dates set for November 2029.]]></description><link>https://newsletter.glp1studio.com/p/lilly-registers-two-eloratzp-obesity</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/lilly-registers-two-eloratzp-obesity</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Tue, 20 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/7de440f0-5910-43aa-9763-0fd2f8efa32f_1880x1253.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/blood-sugar-meter-and-sweets-on-the-blue-background-6942013/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!gjc8!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7de440f0-5910-43aa-9763-0fd2f8efa32f_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!gjc8!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7de440f0-5910-43aa-9763-0fd2f8efa32f_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!gjc8!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7de440f0-5910-43aa-9763-0fd2f8efa32f_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!gjc8!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7de440f0-5910-43aa-9763-0fd2f8efa32f_1880x1253.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!gjc8!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7de440f0-5910-43aa-9763-0fd2f8efa32f_1880x1253.jpeg" width="1456" height="970" 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20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by Nataliya Vaitkevich on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>Massachusetts General Hospital has registered a Phase 2 pilot trial testing semaglutide for cannabis use disorder, not yet recruiting, with a listed start in January 2027.</h6></li><li><h6>Eli Lilly's Phase 3 trial will test its EloraTZP combination against tirzepatide, eloralintide, and placebo in adults with obesity, with a listed completion date of November 2029.</h6></li><li><h6>A second Lilly Phase 3 trial compares EloraTZP against tirzepatide alone in people with obesity or overweight and type 2 diabetes, also not yet recruiting.</h6></li><li><h6>A meta-analysis in Diabetes, Obesity and Metabolism found the available evidence insufficient to determine whether semaglutide is associated with changes in handgrip strength.</h6></li></ul></div><p>Three of these four items are trials that have not yet started recruiting, so they say less about quick answers than about how much is still ahead. Two trials from Eli Lilly and one from Massachusetts General Hospital are registered, with completion dates years away. A separate meta-analysis of existing semaglutide data shows how much uncertainty remains even for questions researchers have already studied. Most of what is new here is a plan, not a result.</p><p>Massachusetts General Hospital has registered a Phase 2 pilot trial testing semaglutide for cannabis use disorder. The study is not yet recruiting, and its listed start date is January 2027, with completion planned for March 2029. Researchers want to learn whether semaglutide affects brain reactivity to cannabis-related cues and whether it can safely reduce how often participants use cannabis. Participants in the study would receive weekly injections of semaglutide, at doses between 0.25 and 0.5 mg, across eight weeks. The listed enrollment is 40 adults. This is an early-stage plan, so there is nothing to report beyond the registration itself.</p><p>Eli Lilly has registered a Phase 3 trial comparing its EloraTZP combination, which pairs eloralintide and tirzepatide, against tirzepatide alone, eloralintide alone, and placebo in adults with obesity. The trial is not yet recruiting, with planned enrollment of 2,115 participants. Its listed start date is December 2026, and its completion date is set for November 2029, so any results are still years out. Participation in the study would last about two years.</p><p>A second Lilly Phase 3 trial also tests EloraTZP, this time against tirzepatide alone, in adults with obesity or overweight who also have type 2 diabetes. This trial is not yet recruiting either, with planned enrollment of 1,000 participants. Its listed start date is November 2026, and its completion date is also set for November 2029. As with the first trial, participation would last about two years.</p><p>A meta-analysis in Diabetes, Obesity and Metabolism looked at whether semaglutide is associated with changes in muscle strength, measured by handgrip strength. The analysis found the available evidence insufficient to determine this, because the main synthesis relied on uncontrolled within-group changes, with very low certainty and significant heterogeneity. The authors say these findings do not establish strength preservation or a causal treatment effect.</p><p>The trial registrations are listed on ClinicalTrials.gov under NCT07879612, NCT07881432 and NCT07881458, and the meta-analysis is published in Diabetes, Obesity and Metabolism (DOI 10.1111/dom.71432).</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-20">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[Medicaid GLP-1 spending swung by state in Q1 2026]]></title><description><![CDATA[California's Medicaid prescriptions for Wegovy, Zepbound and Saxenda dropped by more than three quarters in Q1 2026, while its total GLP-1 prescriptions fell about 44%.]]></description><link>https://newsletter.glp1studio.com/p/medicaid-glp-1-spending-swung-by</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/medicaid-glp-1-spending-swung-by</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Mon, 19 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/c0a4dd72-b2f6-4e4e-aa50-c5791998f610_1880x1254.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/bottles-with-medications-10022079/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!hP6-!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fc0a4dd72-b2f6-4e4e-aa50-c5791998f610_1880x1254.jpeg 424w, https://substackcdn.com/image/fetch/$s_!hP6-!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fc0a4dd72-b2f6-4e4e-aa50-c5791998f610_1880x1254.jpeg 848w, https://substackcdn.com/image/fetch/$s_!hP6-!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fc0a4dd72-b2f6-4e4e-aa50-c5791998f610_1880x1254.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!hP6-!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fc0a4dd72-b2f6-4e4e-aa50-c5791998f610_1880x1254.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!hP6-!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fc0a4dd72-b2f6-4e4e-aa50-c5791998f610_1880x1254.jpeg" width="1456" height="971" data-attrs="{&quot;src&quot;:&quot;https://substack-post-media.s3.amazonaws.com/public/images/c0a4dd72-b2f6-4e4e-aa50-c5791998f610_1880x1254.jpeg&quot;,&quot;srcNoWatermark&quot;:null,&quot;fullscreen&quot;:null,&quot;imageSize&quot;:null,&quot;height&quot;:971,&quot;width&quot;:1456,&quot;resizeWidth&quot;:null,&quot;bytes&quot;:91203,&quot;alt&quot;:null,&quot;title&quot;:null,&quot;type&quot;:&quot;image/jpeg&quot;,&quot;href&quot;:&quot;https://www.pexels.com/photo/bottles-with-medications-10022079/&quot;,&quot;belowTheFold&quot;:false,&quot;topImage&quot;:true,&quot;internalRedirect&quot;:null,&quot;isProcessing&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" class="sizing-normal" alt="" srcset="https://substackcdn.com/image/fetch/$s_!hP6-!,w_424,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fc0a4dd72-b2f6-4e4e-aa50-c5791998f610_1880x1254.jpeg 424w, https://substackcdn.com/image/fetch/$s_!hP6-!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fc0a4dd72-b2f6-4e4e-aa50-c5791998f610_1880x1254.jpeg 848w, https://substackcdn.com/image/fetch/$s_!hP6-!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fc0a4dd72-b2f6-4e4e-aa50-c5791998f610_1880x1254.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!hP6-!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fc0a4dd72-b2f6-4e4e-aa50-c5791998f610_1880x1254.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by Towfiqu barbhuiya on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>California Medicaid prescriptions for Wegovy, Zepbound and Saxenda fell from 523,015 in Q4 2025 to 126,912 in Q1 2026 (data dated March 31, 2026).</h6></li><li><h6>North Carolina Medicaid spending on GLP-1 drugs rose to $145.7 million in Q1 2026, up from $89.6 million in Q4 2025 (data dated March 31, 2026).</h6></li><li><h6>Missouri Medicaid spending on GLP-1 drugs rose to $121.2 million in Q1 2026, up from $102.2 million in Q4 2025 (data dated March 31, 2026).</h6></li><li><h6>Nationwide Medicaid spending on GLP-1 drugs fell 20% from Q4 2025 to $2.58 billion for 2,412,872 prescriptions in Q1 2026 (data dated March 31, 2026).</h6></li><li><h6>Trulicity is on the CMS selected drug list for Medicare price negotiation, per a CMS update dated January 27, 2026, with any negotiated price taking effect January 1, 2028.</h6></li></ul></div><p>Medicaid data from the Centers for Medicare and Medicaid Services, covering the first quarter of 2026, shows GLP-1 spending moved in different directions depending on the state. Some states paid out much less than they did the previous quarter, while others paid out noticeably more. These are Medicaid spending and prescription figures, and the amounts are what Medicaid reimbursed pharmacies before manufacturer rebates. Here is what the numbers show, state by state and nationwide.</p><p>The swing in California is hard to miss. California's Medicaid drug utilization data for the first quarter of 2026 is dated March 31, 2026. Prescriptions for Wegovy, Zepbound and Saxenda fell from 523,015 in Q4 2025 to 126,912 in Q1 2026. That is a steep drop in just one quarter. California's total Medicaid GLP-1 spending fell from $989.6 million in Q4 2025 to $537.6 million in Q1 2026, and its total GLP-1 prescriptions fell from 882,881 to 498,483.</p><p>Not every state moved the same direction. North Carolina's Medicaid program reported GLP-1 spending of $145.7 million for Q1 2026, dated March 31, 2026. That is up from $89.6 million in Q4 2025. North Carolina was named one of the five highest-spending states for GLP-1 medicines in Medicaid in Q1 2026.</p><p>Missouri followed a similar path. Missouri's Medicaid program reported GLP-1 spending of $121.2 million for Q1 2026, dated March 31, 2026, up from $102.2 million in Q4 2025. Missouri was also named one of the five highest-spending states for GLP-1 medicines in Medicaid in Q1 2026.</p><p>Put the states together and the national trend looks different from some of the individual stories. Medicaid paid $2.58 billion nationwide for 2,412,872 GLP-1 prescriptions in Q1 2026, dated March 31, 2026. That is a 20% drop in dollars from the $3.22 billion Medicaid paid for 3,012,864 prescriptions in Q4 2025. The overall direction, in other words, was down.</p><p>There is also a separate Medicare item. Trulicity is on the CMS selected drug list for Medicare price negotiation, and CMS's most recent update to its entries is dated January 27, 2026. Any negotiated price would take effect on January 1, 2028, and CMS has not yet posted a negotiated price. The negotiated price applies to Medicare Part D and is not a patient copay.</p><p>The figures come from the CMS State Drug Utilization Data for Medicaid, and the Trulicity item comes from the CMS Drug Price Negotiation Program. The amounts are before manufacturer rebates, so you can compare the exact numbers directly with the CMS data.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-19">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[A digital-first GLP-1 program reports six months of real-world data]]></title><description><![CDATA[The cohort had no comparator group and paid out of pocket, so the results show feasibility, not proof it works better.]]></description><link>https://newsletter.glp1studio.com/p/a-digital-first-glp-1-program-reports</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/a-digital-first-glp-1-program-reports</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Sun, 18 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/0551e9e0-ea64-4d1f-a3fd-5c51e686fbe3_1880x1253.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/a-woman-using-a-smart-phone-5253846/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!ubwM!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F0551e9e0-ea64-4d1f-a3fd-5c51e686fbe3_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!ubwM!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F0551e9e0-ea64-4d1f-a3fd-5c51e686fbe3_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!ubwM!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F0551e9e0-ea64-4d1f-a3fd-5c51e686fbe3_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!ubwM!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F0551e9e0-ea64-4d1f-a3fd-5c51e686fbe3_1880x1253.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!ubwM!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F0551e9e0-ea64-4d1f-a3fd-5c51e686fbe3_1880x1253.jpeg" width="1456" height="970" data-attrs="{&quot;src&quot;:&quot;https://substack-post-media.s3.amazonaws.com/public/images/0551e9e0-ea64-4d1f-a3fd-5c51e686fbe3_1880x1253.jpeg&quot;,&quot;srcNoWatermark&quot;:null,&quot;fullscreen&quot;:null,&quot;imageSize&quot;:null,&quot;height&quot;:970,&quot;width&quot;:1456,&quot;resizeWidth&quot;:null,&quot;bytes&quot;:167601,&quot;alt&quot;:null,&quot;title&quot;:null,&quot;type&quot;:&quot;image/jpeg&quot;,&quot;href&quot;:&quot;https://www.pexels.com/photo/a-woman-using-a-smart-phone-5253846/&quot;,&quot;belowTheFold&quot;:false,&quot;topImage&quot;:true,&quot;internalRedirect&quot;:null,&quot;isProcessing&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" class="sizing-normal" alt="" srcset="https://substackcdn.com/image/fetch/$s_!ubwM!,w_424,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F0551e9e0-ea64-4d1f-a3fd-5c51e686fbe3_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!ubwM!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F0551e9e0-ea64-4d1f-a3fd-5c51e686fbe3_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!ubwM!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F0551e9e0-ea64-4d1f-a3fd-5c51e686fbe3_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!ubwM!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F0551e9e0-ea64-4d1f-a3fd-5c51e686fbe3_1880x1253.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by Antonius Ferret on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>A Nature Medicine cohort study from October 16, 2026 found digital GLP-1 delivery feasible, but had no comparator group and only 6 months follow-up.</h6></li></ul></div><p>A new cohort study published in Nature Medicine looked at how women accessed GLP-1 receptor agonist therapy through a digital-first care model. The study, dated October 16, 2026, found this approach feasible to deliver at scale. If you are weighing a digital GLP-1 program, this is worth understanding before you sign up, because the study has real limits on what it can tell you. It cannot tell you whether the digital model works better than other options.</p><p>This is the kind of study that tells you something can be done, not that it is the best way to do it. The study, identified as 42888249 and published in Nature Medicine on October 16, 2026, examined real-world, digital-first delivery of GLP-1 receptor agonist therapy in women. Its status is listed as a cohort study, and its findings support the feasibility of delivering structured, digitally enabled obesity pharmacotherapy at scale, offering prospective real-world implementation evidence for this care model. That sounds promising, but the fine print matters here. The source itself notes that interpretation is limited by the observational design, the absence of a comparator group, a self-pay population, and only six months of follow-up, which means there is no group to compare outcomes against and no long-term data yet.</p><p>That is the full picture this record gives us, nothing more and nothing less. You can read the complete entry for this study, along with the rest of what we tracked on October 18, 2026, over at glp1laws.com.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-18">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[EMA posts update on a new oral GLP-1 medicine]]></title><description><![CDATA[The agency describes a once-daily tablet as an alternative to other oral and injectable GLP-1 medicines.]]></description><link>https://newsletter.glp1studio.com/p/ema-posts-update-on-a-new-oral-glp</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/ema-posts-update-on-a-new-oral-glp</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Sat, 17 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/066a34e2-ee87-4b9c-82d7-fe2610142244_1880x1058.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/close-up-of-medicine-tablets-on-yellow-background-39576247/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!-BM3!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F066a34e2-ee87-4b9c-82d7-fe2610142244_1880x1058.jpeg 424w, https://substackcdn.com/image/fetch/$s_!-BM3!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F066a34e2-ee87-4b9c-82d7-fe2610142244_1880x1058.jpeg 848w, https://substackcdn.com/image/fetch/$s_!-BM3!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F066a34e2-ee87-4b9c-82d7-fe2610142244_1880x1058.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!-BM3!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F066a34e2-ee87-4b9c-82d7-fe2610142244_1880x1058.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!-BM3!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F066a34e2-ee87-4b9c-82d7-fe2610142244_1880x1058.jpeg" width="1456" height="819" data-attrs="{&quot;src&quot;:&quot;https://substack-post-media.s3.amazonaws.com/public/images/066a34e2-ee87-4b9c-82d7-fe2610142244_1880x1058.jpeg&quot;,&quot;srcNoWatermark&quot;:null,&quot;fullscreen&quot;:null,&quot;imageSize&quot;:null,&quot;height&quot;:819,&quot;width&quot;:1456,&quot;resizeWidth&quot;:null,&quot;bytes&quot;:85227,&quot;alt&quot;:null,&quot;title&quot;:null,&quot;type&quot;:&quot;image/jpeg&quot;,&quot;href&quot;:&quot;https://www.pexels.com/photo/close-up-of-medicine-tablets-on-yellow-background-39576247/&quot;,&quot;belowTheFold&quot;:false,&quot;topImage&quot;:true,&quot;internalRedirect&quot;:null,&quot;isProcessing&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" class="sizing-normal" alt="" srcset="https://substackcdn.com/image/fetch/$s_!-BM3!,w_424,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F066a34e2-ee87-4b9c-82d7-fe2610142244_1880x1058.jpeg 424w, https://substackcdn.com/image/fetch/$s_!-BM3!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F066a34e2-ee87-4b9c-82d7-fe2610142244_1880x1058.jpeg 848w, https://substackcdn.com/image/fetch/$s_!-BM3!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F066a34e2-ee87-4b9c-82d7-fe2610142244_1880x1058.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!-BM3!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F066a34e2-ee87-4b9c-82d7-fe2610142244_1880x1058.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by UMA media on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>Maine signed LD 1970 into law on March 19, 2026, an act on consent for HIV testing and disclosure of related medical information for insurance purposes.</h6></li><li><h6>A Stanford University trial on post-bariatric hypoglycemia, not yet recruiting, plans to test diet, a GLP-1 or dual GIP/GLP-1 receptor agonist, and TORe.</h6></li><li><h6>The EMA published an update on October 16, 2026 describing a once-daily oral GLP-1 tablet as an alternative to other oral and injectable GLP-1 medicines.</h6></li></ul></div><p>GLP1Laws tracked three developments on Saturday, October 17, 2026, spanning state legislation, clinical research, and a regulatory update from Europe's medicines agency. Together they touch on insurance disclosure rules, a planned trial for a surgery-related complication, and a European agency update about an oral GLP-1 medicine.</p><p>Maine signed LD 1970 into law on March 19, 2026, which was several months before this roundup, so this is background rather than fresh news. The act amends the state's laws on consent for HIV testing and on disclosure of related medical information for insurance purposes. It had 10 sponsors, and its status is listed as signed by the governor. Its title concerns HIV testing consent and insurance disclosure and does not mention GLP-1 medicines.</p><p>Stanford University has registered a clinical trial for post-bariatric hypoglycemia, a complication of upper gastrointestinal surgery. The trial is not yet recruiting, so there are no results to share. It plans to evaluate three approaches: dietary modification, treatment with a GLP-1 receptor agonist or a dual GIP/GLP-1 receptor agonist, and a procedure called transoral outlet reduction (TORe). Its listed enrollment is 30 people, its listed start date is November 1, 2026, and completion is listed for November 2031.</p><p>The European Medicines Agency posted an update on October 16, 2026 about a new oral GLP-1 medicine for weight management and type 2 diabetes. The agency describes it as a once-daily tablet that provides an alternative to other oral and injectable GLP-1 medicines. The update as listed does not name the medicine or give details on pricing, availability, or approval conditions.</p><p>You can find the full record for each of these three items on glp1laws.com, with the original sourcing and dates included.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-17">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[Counterfeit weight loss pens worth 2 million pounds seized in UK]]></title><description><![CDATA[A UK cohort study looked at tirzepatide treatment patterns around a price increase, and a separate cohort study found GLP-1 use associated with lower amputation risk in diabetic foot ulcer.]]></description><link>https://newsletter.glp1studio.com/p/counterfeit-weight-loss-pens-worth</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/counterfeit-weight-loss-pens-worth</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Fri, 16 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/7b33d808-c376-442a-a0ce-5d642a8b6bf4_1880x1253.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/close-up-of-a-person-holding-syringes-19677805/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!1cu-!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7b33d808-c376-442a-a0ce-5d642a8b6bf4_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!1cu-!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7b33d808-c376-442a-a0ce-5d642a8b6bf4_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!1cu-!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7b33d808-c376-442a-a0ce-5d642a8b6bf4_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!1cu-!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7b33d808-c376-442a-a0ce-5d642a8b6bf4_1880x1253.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!1cu-!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7b33d808-c376-442a-a0ce-5d642a8b6bf4_1880x1253.jpeg" width="1456" height="970" data-attrs="{&quot;src&quot;:&quot;https://substack-post-media.s3.amazonaws.com/public/images/7b33d808-c376-442a-a0ce-5d642a8b6bf4_1880x1253.jpeg&quot;,&quot;srcNoWatermark&quot;:null,&quot;fullscreen&quot;:null,&quot;imageSize&quot;:null,&quot;height&quot;:970,&quot;width&quot;:1456,&quot;resizeWidth&quot;:null,&quot;bytes&quot;:106961,&quot;alt&quot;:null,&quot;title&quot;:null,&quot;type&quot;:&quot;image/jpeg&quot;,&quot;href&quot;:&quot;https://www.pexels.com/photo/close-up-of-a-person-holding-syringes-19677805/&quot;,&quot;belowTheFold&quot;:false,&quot;topImage&quot;:true,&quot;internalRedirect&quot;:null,&quot;isProcessing&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" class="sizing-normal" alt="" srcset="https://substackcdn.com/image/fetch/$s_!1cu-!,w_424,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7b33d808-c376-442a-a0ce-5d642a8b6bf4_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!1cu-!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7b33d808-c376-442a-a0ce-5d642a8b6bf4_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!1cu-!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7b33d808-c376-442a-a0ce-5d642a8b6bf4_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!1cu-!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7b33d808-c376-442a-a0ce-5d642a8b6bf4_1880x1253.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by Alessandra Ara&#250;jo on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>The MHRA announced on October 15, 2026 that counterfeit weight loss medicines worth about &#163;2 million were seized the night before in a raid with West Midlands Police.</h6></li><li><h6>A cohort study dated October 14, 2026 reported that tirzepatide treatment initiation and switching changed markedly around a price increase among self-paying UK adults with overweight or obesity.</h6></li><li><h6>A hypothesis-generating cohort study dated October 14, 2026 found GLP-1 receptor agonist use associated with lower risk of lower extremity amputation in adults with type 2 diabetes and foot ulcer.</h6></li><li><h6>A Phase 2 feasibility trial dated October 15, 2026, not yet recruiting, plans to study tirzepatide in young adult sarcoma survivors who are overweight or obese.</h6></li><li><h6>Two trials dated October 15, 2026, both not yet recruiting, plan to study semaglutide's effects on body composition and performance in well-trained runners, one long-term and one short-term.</h6></li></ul></div><p>They range from a counterfeit seizure in the UK to new research on how tirzepatide and GLP-1 medicines are used and studied. None of what follows is medical advice.</p><p>The MHRA and West Midlands Police carried out a raid that seized counterfeit weight loss medicines worth approximately &#163;2 million. In a press release published October 15, 2026, the MHRA said the seizure took place the night before. The MHRA listed this as enforcement and a public warning.</p><p>A cohort study dated October 14, 2026 in Diabetes, Obesity and Metabolism covered over one million self-paying UK adults with overweight or obesity who used a single UK telehealth provider. The study looked at treatment patterns and weight outcomes before and after a tirzepatide price increase. It reported that treatment initiation and switching changed markedly around the increase.</p><p>A cohort study dated October 14, 2026 in Diabetes, Obesity and Metabolism found that GLP-1 receptor agonist use was associated with lower risk of lower extremity amputation in adults with type 2 diabetes and foot ulcer who had no coded peripheral arterial disease. The association held up across six pre-specified sensitivity analyses. The authors describe these observational findings as hypothesis-generating and say they require prospective confirmation.</p><p>The PROACT AYA trial, dated October 15, 2026 on ClinicalTrials.gov, is a single-arm, single-center, open-label Phase 2 feasibility study of tirzepatide sponsored by M.D. Anderson Cancer Center. It plans to enroll 30 young adults, ages 18 to 39, with soft tissue or bone sarcoma who are overweight or obese, completed doxorubicin-based chemotherapy about three months before enrollment, and have preserved heart function. The trial is not yet recruiting; its listed start date is December 31, 2026 and its listed completion date is December 31, 2036.</p><p>Two trials dated October 15, 2026 are sponsored by Morten Hostrup, PhD. Each is a randomized, placebo-controlled parallel study of semaglutide in well-trained male and female runners, one looking at long-term effects and the other at short-term effects. They aim to measure body composition, muscle mass, volume and function, running economy, and performance, with the long-term study also measuring hormonal markers, and each plans 41 participants. Both are not yet recruiting, with listed start dates of October 14, 2026 and completion dates of April 30, 2028.</p><p>These are the six developments dated October 14 and 15, 2026. The seizure was announced by the MHRA, the two cohort studies were published in Diabetes, Obesity and Metabolism, and the three trials are registered on ClinicalTrials.gov, where you can read each one in full.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-16">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[GLP-1 therapy tied to less psychiatric acute care in diabetes]]></title><description><![CDATA[An observational cohort study looked at adults with schizophrenia and type 2 diabetes, comparing GLP-1 therapy with DPP-4 and SGLT2 inhibitors.]]></description><link>https://newsletter.glp1studio.com/p/glp-1-therapy-tied-to-less-psychiatric</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/glp-1-therapy-tied-to-less-psychiatric</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Thu, 15 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/4c77523e-74b4-469c-8356-b94c47abea8f_1880x1253.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/white-and-black-click-pen-on-white-printer-paper-6942255/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!7KW0!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4c77523e-74b4-469c-8356-b94c47abea8f_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!7KW0!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4c77523e-74b4-469c-8356-b94c47abea8f_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!7KW0!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4c77523e-74b4-469c-8356-b94c47abea8f_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!7KW0!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4c77523e-74b4-469c-8356-b94c47abea8f_1880x1253.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!7KW0!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4c77523e-74b4-469c-8356-b94c47abea8f_1880x1253.jpeg" width="1456" height="970" data-attrs="{&quot;src&quot;:&quot;https://substack-post-media.s3.amazonaws.com/public/images/4c77523e-74b4-469c-8356-b94c47abea8f_1880x1253.jpeg&quot;,&quot;srcNoWatermark&quot;:null,&quot;fullscreen&quot;:null,&quot;imageSize&quot;:null,&quot;height&quot;:970,&quot;width&quot;:1456,&quot;resizeWidth&quot;:null,&quot;bytes&quot;:304972,&quot;alt&quot;:null,&quot;title&quot;:null,&quot;type&quot;:&quot;image/jpeg&quot;,&quot;href&quot;:&quot;https://www.pexels.com/photo/white-and-black-click-pen-on-white-printer-paper-6942255/&quot;,&quot;belowTheFold&quot;:false,&quot;topImage&quot;:true,&quot;internalRedirect&quot;:null,&quot;isProcessing&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" class="sizing-normal" alt="" srcset="https://substackcdn.com/image/fetch/$s_!7KW0!,w_424,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4c77523e-74b4-469c-8356-b94c47abea8f_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!7KW0!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4c77523e-74b4-469c-8356-b94c47abea8f_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!7KW0!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4c77523e-74b4-469c-8356-b94c47abea8f_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!7KW0!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4c77523e-74b4-469c-8356-b94c47abea8f_1880x1253.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by Nataliya Vaitkevich on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>The FutureShape Family trial, sponsored by Signe Torekov, is not yet recruiting. ClinicalTrials.gov lists a start date of October 1, 2026 and a completion date of January 31, 2031.</h6></li><li><h6>A preprint posted on medRxiv, not yet peer reviewed, found GLP-1 receptor agonists and SGLT2 inhibitors had no detectable effect on osteoarthritis-related serious adverse events over about two years.</h6></li><li><h6>A Lancet Psychiatry observational cohort study found GLP-1 therapy initiation was associated with lower psychiatric acute-care use in adults with schizophrenia and type 2 diabetes.</h6></li></ul></div><p>Three items touching GLP-1 research are covered here, from a trial that is not yet recruiting to a study on mental health outcomes. If you take or are considering a GLP-1 medication, these updates show what each item reports and what it does not.</p><p>The FutureShape Family trial, sponsored by Signe Torekov, is listed as Phase 4 and is not yet recruiting participants. ClinicalTrials.gov lists a start date of October 1, 2026 and a completion date of January 31, 2031. The trial is registered under NCT07872904 and lists obesity and overweight as its conditions. Interventions listed are family care, standard care, semaglutide (administered by PDS290 pen-injector) and placebo (administered by PDS290 pen-injector). Enrollment is listed as 400. So there is nothing to report yet beyond the registration itself.</p><p>A preprint posted on medRxiv looked at whether drugs proposed to protect or harm joints change serious osteoarthritis events, drawing on adverse event tables from 881 randomized trials. It found that GLP-1 receptor agonists and SGLT2 inhibitors had no detectable effect on osteoarthritis-related serious adverse events over about two years, in trials that detected their known effects. The preprint says slow or modest structural effects remain possible, and the paper has not been peer reviewed.</p><p>An observational cohort study in The Lancet Psychiatry, using electronic health records data from the USA, followed adults with schizophrenia and type 2 diabetes. It found that starting GLP-1 therapy was associated with lower psychiatric acute-care use than not starting it or starting a DPP-4 or SGLT2 inhibitor. The study notes that potential residual confounding and selection bias restrict how broadly the results can be applied.</p><p>These three items are different kinds of evidence: a trial registration with no results, a preprint that has not been peer reviewed, and an observational study that shows an association rather than a cause.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-15">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[Amgen plans a home-use trial for its injectable obesity drug]]></title><description><![CDATA[The autoinjector study has not started recruiting yet, with completion not expected until September 2027.]]></description><link>https://newsletter.glp1studio.com/p/amgen-plans-a-home-use-trial-for</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/amgen-plans-a-home-use-trial-for</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Wed, 14 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/a8750718-26f2-4763-9475-a0e61ba575fa_1880x1253.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/elderly-couple-sitting-on-brown-sofa-5790805/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!r7t6!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa8750718-26f2-4763-9475-a0e61ba575fa_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!r7t6!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa8750718-26f2-4763-9475-a0e61ba575fa_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!r7t6!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa8750718-26f2-4763-9475-a0e61ba575fa_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!r7t6!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa8750718-26f2-4763-9475-a0e61ba575fa_1880x1253.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!r7t6!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa8750718-26f2-4763-9475-a0e61ba575fa_1880x1253.jpeg" width="1456" height="970" data-attrs="{&quot;src&quot;:&quot;https://substack-post-media.s3.amazonaws.com/public/images/a8750718-26f2-4763-9475-a0e61ba575fa_1880x1253.jpeg&quot;,&quot;srcNoWatermark&quot;:null,&quot;fullscreen&quot;:null,&quot;imageSize&quot;:null,&quot;height&quot;:970,&quot;width&quot;:1456,&quot;resizeWidth&quot;:null,&quot;bytes&quot;:147163,&quot;alt&quot;:null,&quot;title&quot;:null,&quot;type&quot;:&quot;image/jpeg&quot;,&quot;href&quot;:&quot;https://www.pexels.com/photo/elderly-couple-sitting-on-brown-sofa-5790805/&quot;,&quot;belowTheFold&quot;:false,&quot;topImage&quot;:true,&quot;internalRedirect&quot;:null,&quot;isProcessing&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" class="sizing-normal" alt="" srcset="https://substackcdn.com/image/fetch/$s_!r7t6!,w_424,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa8750718-26f2-4763-9475-a0e61ba575fa_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!r7t6!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa8750718-26f2-4763-9475-a0e61ba575fa_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!r7t6!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa8750718-26f2-4763-9475-a0e61ba575fa_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!r7t6!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa8750718-26f2-4763-9475-a0e61ba575fa_1880x1253.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by Vlada Karpovich on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>Eli Lilly's trademark infringement (Lanham Act) lawsuit against MedShape Weight Loss Clinic LLC is pending in D. Ariz., with its latest docket activity dated October 8, 2026.</h6></li><li><h6>A Phase 4 trial recruiting at KU Leuven aims to find which patients respond best to semaglutide for binge eating.</h6></li><li><h6>Amgen's Phase 3 trial on at-home autoinjector use of maridebart cafraglutide has not started recruiting, with 230 participants planned.</h6></li><li><h6>Sheba Medical Center's Phase 2 ELITE trial on healthy aging has finished running, but its results are pending.</h6></li><li><h6>A preprint dated October 13, 2026 reported that adding nutrition therapy to incretin-based obesity care was associated with greater 12-month weight loss than care without it.</h6></li></ul></div><p>Five developments are covered here: one trademark court case and four research items. The lawsuit is pending, two trials are listed as not yet or currently recruiting, one trial has finished with results pending, and one preprint has not been peer reviewed.</p><p>Eli Lilly's lawsuit against MedShape Weight Loss Clinic is pending in federal court. Eli Lilly and Company v. MedShape Weight Loss Clinic LLC is filed in the District Court, D. Arizona, under the nature of suit "890 Other Statutes: Other Statutory Actions," with Eli Lilly and Company as plaintiff and MedShape Weight Loss Clinic LLC as defendant. The cause of action is listed as trademark infringement under the Lanham Act, which is an allegation, not a finding. The docket status is Pending, and its latest docket activity is dated October 8, 2026.</p><p>A Phase 4 trial recruiting at Universitaire Ziekenhuizen KU Leuven is trying to answer a specific question about semaglutide and eating behavior. The trial, A Neuropsychobiological Approach to Optimize Patient Selection for GLP-1-based Pharmacotherapy for Weight Management Across the Binge Eating Spectrum, is sponsored by Universitaire Ziekenhuizen KU Leuven and is listed under identifier NCT07870538. Its goal is to investigate how GLP-1 receptor analogs, such as semaglutide (Wegovy), influence processes that determine eating behavior, binge eating, and weight regulation via the gut-brain axis, with the aim of identifying for whom semaglutide works best. Participants will receive six months of semaglutide treatment, attend two to four clinic visits, and wear a smartwatch while completing smartphone questionnaires, across a planned enrollment of 96 people. The trial covers obesity and overweight conditions and is listed as recruiting as of October 13, 2026.</p><p>Amgen's Phase 3 trial on at-home use of maridebart cafraglutide has not yet opened for recruitment. The study, Home Self-administration of Maridebart Cafraglutide With Autoinjector in Adults Living With Obesity or Overweight, is sponsored by Amgen and registered as NCT07871409, with a status of Not yet recruiting as of October 13, 2026. Its main objective is to assess whether participants can self-administer subcutaneous doses of maridebart cafraglutide at home using an autoinjector device, with a planned enrollment of 230 people. The trial's start date is listed as October 28, 2026, and completion is listed as September 8, 2027.</p><p>Sheba Medical Center's Phase 2 ELITE trial on healthy aging has finished running, though its results are pending. ELITE, short for Evidence-Based Longevity Interventions and Targeted Engagement, was a randomized, open-label, two-active-arm pilot conducted at Sheba Medical Center in Ramat Gan, Israel, with a status of Completed (results pending) as of October 13, 2026. The study aimed to characterize individual response to multidomain healthy-aging interventions over about eight weeks, combining a clinical measure of muscular, immune, and cognitive function with frequent digital monitoring between visits. Its primary outcome was the change from baseline to Week 8 in the Muscular-Immune-Cognitive Composite, and its listed start date was November 17, 2025, with completion listed as February 25, 2026.</p><p>A preprint posted to medRxiv looked at what happens when nutrition therapy is added to incretin-based obesity care. The preprint, Real-World Twelve-Month Weight Loss Outcomes in a Comprehensive Obesity Care Program Utilizing Individualized Nutrition Therapy and Incretin-Based Obesity Medications, carries the identifier 10.64898/2026.10.09.26365158 and is dated October 13, 2026, with a status of preprint, not peer reviewed. It found that integrating individualized carbohydrate-reduced nutritional therapy with incretin-based obesity medication care was associated with greater 12-month weight loss than incretin-based care without structured nutritional therapy. The authors describe this as support for further evaluation of individualized nutritional approaches as an adjunct to incretin-based obesity pharmacotherapy. Keep in mind that this has not yet been peer reviewed.</p><p>That is five developments: a pending lawsuit, two trials that are recruiting or not yet recruiting, one completed trial with results pending, and one preprint that has not been peer reviewed. The court docket, the trial registrations on ClinicalTrials.gov and the medRxiv preprint are the places where updates would appear.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-14">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[Novo Nordisk registers phase 1 trial of switching to zenagamtide]]></title><description><![CDATA[The registered study has not started recruiting, and it asks how people on maintenance tirzepatide tolerate a switch.]]></description><link>https://newsletter.glp1studio.com/p/novo-nordisk-registers-phase-1-trial</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/novo-nordisk-registers-phase-1-trial</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Tue, 13 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/9e932a33-310f-450c-9235-185239bed867_1880x1253.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/diabetic-kit-and-insulin-over-a-purple-surface-6941102/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!vZT7!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9e932a33-310f-450c-9235-185239bed867_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!vZT7!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9e932a33-310f-450c-9235-185239bed867_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!vZT7!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9e932a33-310f-450c-9235-185239bed867_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!vZT7!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9e932a33-310f-450c-9235-185239bed867_1880x1253.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!vZT7!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9e932a33-310f-450c-9235-185239bed867_1880x1253.jpeg" width="1456" height="970" data-attrs="{&quot;src&quot;:&quot;https://substack-post-media.s3.amazonaws.com/public/images/9e932a33-310f-450c-9235-185239bed867_1880x1253.jpeg&quot;,&quot;srcNoWatermark&quot;:null,&quot;fullscreen&quot;:null,&quot;imageSize&quot;:null,&quot;height&quot;:970,&quot;width&quot;:1456,&quot;resizeWidth&quot;:null,&quot;bytes&quot;:203829,&quot;alt&quot;:null,&quot;title&quot;:null,&quot;type&quot;:&quot;image/jpeg&quot;,&quot;href&quot;:&quot;https://www.pexels.com/photo/diabetic-kit-and-insulin-over-a-purple-surface-6941102/&quot;,&quot;belowTheFold&quot;:false,&quot;topImage&quot;:true,&quot;internalRedirect&quot;:null,&quot;isProcessing&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" class="sizing-normal" alt="" srcset="https://substackcdn.com/image/fetch/$s_!vZT7!,w_424,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9e932a33-310f-450c-9235-185239bed867_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!vZT7!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9e932a33-310f-450c-9235-185239bed867_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!vZT7!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9e932a33-310f-450c-9235-185239bed867_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!vZT7!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9e932a33-310f-450c-9235-185239bed867_1880x1253.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by Nataliya Vaitkevich on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>Novo Nordisk's phase 1 trial, not yet recruiting, would test switching from maintenance tirzepatide to a new drug called zenagamtide.</h6></li><li><h6>A preprint, not yet peer reviewed, found that in routine practice most patients starting semaglutide or tirzepatide did not remain on therapy, reach a maintenance dose, and have weight documented through the first year.</h6></li><li><h6>A phase III trial published October 7, 2026 found HD1916, a chemically synthesized semaglutide injection, had equivalent body weight reductions to Wegovy, with a comparable safety profile.</h6></li><li><h6>Wampler v. Novo Nordisk Inc is a pending personal injury product liability case in the Eastern District of Pennsylvania, with its latest docket action dated October 8, 2026.</h6></li><li><h6>New York's A 9184 was reprinted as 9184A on October 9, 2026, and has had no votes.</h6></li></ul></div><p>Novo Nordisk has registered a phase 1 trial that would test switching patients from maintenance tirzepatide to a drug called zenagamtide, though it has not started recruiting yet. The other items below are also dated October 6 to 9, 2026, and include a court case and a New York bill about insurer, pharmacy benefit manager and pharmacy control whose description does not mention GLP-1 drugs.</p><p>Novo Nordisk A/S is sponsoring the study, which is phase 1 and was last updated October 9, 2026. It has not started recruiting yet. The trial would test which zenagamtide dose people can switch to from a maintenance dose of tirzepatide, with a planned enrollment of 60 adults with overweight or obesity, with or without type 2 diabetes. All participants will get tirzepatide and zenagamtide.</p><p>A preprint posted October 6, 2026 on medRxiv looked at what happens after people start these drugs in routine practice. It found that most patients who began semaglutide or tirzepatide did not remain on therapy, reach a maintenance dose, and have weight documented through the first year. The preprint has not been peer reviewed. Documented weight loss was greatest among patients who completed each step of care, and the preprint suggests continuation, dose escalation and monitoring as targets for improvement.</p><p>A multicenter phase III trial, published October 7, 2026 in Diabetes, Obesity and Metabolism, tested HD1916, a chemically synthesized semaglutide injection, against the reference product semaglutide sold as Wegovy. The published summary says HD1916 produced equivalent body weight reductions to Wegovy, with a comparable safety profile.</p><p>On the legal side, Wampler v. Novo Nordisk Inc is a personal injury product liability case. It is pending in the Eastern District of Pennsylvania, and its latest docket action is dated October 8, 2026.</p><p>In New York, Assembly bill A 9184 has 9 sponsors and was reprinted as 9184A on October 9, 2026. It has had no votes. The bill would limit overlapping control between insurance companies, pharmacy benefit managers and pharmacies, and it would require divestment of interests in one or more insurance companies and pharmacy benefit managers. It would also bar insurers, pharmacies and PBMs found in violation from receiving payment from certain state programs. It is still a bill, not a law, and its description does not mention GLP-1 drugs.</p><p>The trial registration, the lawsuit and the bill are all ongoing. The HD1916 trial and the preprint have already reported results, and the preprint has not been peer reviewed.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-13">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[Eli Lilly v. Willow Health Services pending in Ninth Circuit]]></title><description><![CDATA[The docket does not say what the dispute is about, and its latest action is dated March 5, 2026.]]></description><link>https://newsletter.glp1studio.com/p/eli-lilly-v-willow-health-services</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/eli-lilly-v-willow-health-services</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Sun, 11 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/1986e8e6-ab5e-4b01-920d-5900c47ff6d2_1880x1255.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/close-up-shot-of-a-woman-in-beige-long-sleeves-preparing-the-glucose-meter-while-standing-beside-a-person-wearing-black-hoodieb-7653647/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!llwJ!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F1986e8e6-ab5e-4b01-920d-5900c47ff6d2_1880x1255.jpeg 424w, https://substackcdn.com/image/fetch/$s_!llwJ!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F1986e8e6-ab5e-4b01-920d-5900c47ff6d2_1880x1255.jpeg 848w, https://substackcdn.com/image/fetch/$s_!llwJ!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F1986e8e6-ab5e-4b01-920d-5900c47ff6d2_1880x1255.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!llwJ!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F1986e8e6-ab5e-4b01-920d-5900c47ff6d2_1880x1255.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!llwJ!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F1986e8e6-ab5e-4b01-920d-5900c47ff6d2_1880x1255.jpeg" width="1456" height="972" data-attrs="{&quot;src&quot;:&quot;https://substack-post-media.s3.amazonaws.com/public/images/1986e8e6-ab5e-4b01-920d-5900c47ff6d2_1880x1255.jpeg&quot;,&quot;srcNoWatermark&quot;:null,&quot;fullscreen&quot;:null,&quot;imageSize&quot;:null,&quot;height&quot;:972,&quot;width&quot;:1456,&quot;resizeWidth&quot;:null,&quot;bytes&quot;:218207,&quot;alt&quot;:null,&quot;title&quot;:null,&quot;type&quot;:&quot;image/jpeg&quot;,&quot;href&quot;:&quot;https://www.pexels.com/photo/close-up-shot-of-a-woman-in-beige-long-sleeves-preparing-the-glucose-meter-while-standing-beside-a-person-wearing-black-hoodieb-7653647/&quot;,&quot;belowTheFold&quot;:false,&quot;topImage&quot;:true,&quot;internalRedirect&quot;:null,&quot;isProcessing&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" class="sizing-normal" alt="" srcset="https://substackcdn.com/image/fetch/$s_!llwJ!,w_424,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F1986e8e6-ab5e-4b01-920d-5900c47ff6d2_1880x1255.jpeg 424w, https://substackcdn.com/image/fetch/$s_!llwJ!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F1986e8e6-ab5e-4b01-920d-5900c47ff6d2_1880x1255.jpeg 848w, https://substackcdn.com/image/fetch/$s_!llwJ!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F1986e8e6-ab5e-4b01-920d-5900c47ff6d2_1880x1255.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!llwJ!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F1986e8e6-ab5e-4b01-920d-5900c47ff6d2_1880x1255.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by Pavel Danilyuk on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>A lawsuit between Eli Lilly and Company and Willow Health Services, Inc. is pending in the Ninth Circuit, and the latest docket action is dated March 5, 2026.</h6></li></ul></div><p>A lawsuit between Eli Lilly and Company and Willow Health Services, Inc. is pending in the Ninth Circuit Court of Appeals. Eli Lilly makes GLP-1 medications, but the docket does not say what the dispute is actually about, so there is little we can tell you beyond the fact that it exists.</p><p>The case, captioned Eli Lilly and Company v. Willow Health Services, Inc., is pending in the Ninth Circuit. Its most recent docket action is dated March 5, 2026. The docket does not describe the subject matter of the dispute, so we cannot say whether it touches on pricing, supply, marketing, patents, or something unrelated to GLP-1 medications. A case being pending simply means it is active and unresolved. It is not a ruling, a settlement, or any kind of finding against either party.</p><p>At this stage, the most accurate thing we can tell you is that this case exists and remains unresolved. We would caution against reading anything further into it until more details become available, whether that means the underlying claims, the parties' arguments, or any outcome from the court.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-11">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[Federal lawsuit against Novo Nordisk is pending in Pennsylvania]]></title><description><![CDATA[The court listing does not say what the case alleges, and the latest docket action is dated October 9, 2026.]]></description><link>https://newsletter.glp1studio.com/p/federal-lawsuit-against-novo-nordisk</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/federal-lawsuit-against-novo-nordisk</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Sat, 10 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/4e850112-ffcb-48f1-b738-a8adcf25fe8b_1731x1300.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/facade-of-the-marseille-courthouse-in-marseille-france-15273107/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!1bd-!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4e850112-ffcb-48f1-b738-a8adcf25fe8b_1731x1300.jpeg 424w, https://substackcdn.com/image/fetch/$s_!1bd-!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4e850112-ffcb-48f1-b738-a8adcf25fe8b_1731x1300.jpeg 848w, https://substackcdn.com/image/fetch/$s_!1bd-!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4e850112-ffcb-48f1-b738-a8adcf25fe8b_1731x1300.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!1bd-!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4e850112-ffcb-48f1-b738-a8adcf25fe8b_1731x1300.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!1bd-!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4e850112-ffcb-48f1-b738-a8adcf25fe8b_1731x1300.jpeg" width="1456" height="1093" data-attrs="{&quot;src&quot;:&quot;https://substack-post-media.s3.amazonaws.com/public/images/4e850112-ffcb-48f1-b738-a8adcf25fe8b_1731x1300.jpeg&quot;,&quot;srcNoWatermark&quot;:null,&quot;fullscreen&quot;:null,&quot;imageSize&quot;:null,&quot;height&quot;:1093,&quot;width&quot;:1456,&quot;resizeWidth&quot;:null,&quot;bytes&quot;:346277,&quot;alt&quot;:null,&quot;title&quot;:null,&quot;type&quot;:&quot;image/jpeg&quot;,&quot;href&quot;:&quot;https://www.pexels.com/photo/facade-of-the-marseille-courthouse-in-marseille-france-15273107/&quot;,&quot;belowTheFold&quot;:false,&quot;topImage&quot;:true,&quot;internalRedirect&quot;:null,&quot;isProcessing&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" class="sizing-normal" alt="" srcset="https://substackcdn.com/image/fetch/$s_!1bd-!,w_424,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4e850112-ffcb-48f1-b738-a8adcf25fe8b_1731x1300.jpeg 424w, https://substackcdn.com/image/fetch/$s_!1bd-!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4e850112-ffcb-48f1-b738-a8adcf25fe8b_1731x1300.jpeg 848w, https://substackcdn.com/image/fetch/$s_!1bd-!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4e850112-ffcb-48f1-b738-a8adcf25fe8b_1731x1300.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!1bd-!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4e850112-ffcb-48f1-b738-a8adcf25fe8b_1731x1300.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by Kabyle Sauvage on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>A lawsuit, Mallet v. Novo Nordisk A/S, is pending in the U.S. District Court for the Eastern District of Pennsylvania, with its latest docket action dated October 9, 2026, and no details on the allegations.</h6></li></ul></div><p>A lawsuit titled Mallet v. Novo Nordisk A/S is pending in the U.S. District Court for the Eastern District of Pennsylvania, and its latest docket action is dated October 9, 2026. The court listing does not say what the case alleges, which means there is no finding of wrongdoing and no confirmed connection to any specific drug or practice. We will share more once the allegations are described publicly.</p><p>The case name, the court, its pending status and the October 9, 2026 docket action are the only confirmed facts we have right now. A lawsuit is an allegation, not a finding, and until the complaint or related filings are described publicly, there is no way to know what claims are being made against Novo Nordisk A/S or whether they touch on any particular product, marketing practice, or safety concern. The docket being active simply means the case has not been dismissed or resolved. Readers should treat this as a case to watch rather than a development that changes anything about currently available GLP-1 medications.</p><p>Given how little is known so far, the most useful step for readers is to wait for the actual allegations to surface before drawing any conclusions about what this lawsuit means. In the meantime, anyone with questions about a specific GLP-1 medication they are taking should rely on their prescribing information and their own health care provider rather than on pending litigation. We will report back if there is more to share.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-10">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[Amgen registers Phase 3 trial against semaglutide]]></title><description><![CDATA[Amgen has registered a Phase 3 trial of maridebart cafraglutide versus semaglutide in type 2 diabetes, planned to start November 2, 2026.]]></description><link>https://newsletter.glp1studio.com/p/amgen-registers-phase-3-trial-against</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/amgen-registers-phase-3-trial-against</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Fri, 09 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/6de3f6e6-e7c6-4918-a92a-f92f2d51f6ef_1880x1253.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/empty-test-tubes-on-racks-8539653/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!idv0!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F6de3f6e6-e7c6-4918-a92a-f92f2d51f6ef_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!idv0!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F6de3f6e6-e7c6-4918-a92a-f92f2d51f6ef_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!idv0!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F6de3f6e6-e7c6-4918-a92a-f92f2d51f6ef_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!idv0!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F6de3f6e6-e7c6-4918-a92a-f92f2d51f6ef_1880x1253.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!idv0!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F6de3f6e6-e7c6-4918-a92a-f92f2d51f6ef_1880x1253.jpeg" width="1456" height="970" data-attrs="{&quot;src&quot;:&quot;https://substack-post-media.s3.amazonaws.com/public/images/6de3f6e6-e7c6-4918-a92a-f92f2d51f6ef_1880x1253.jpeg&quot;,&quot;srcNoWatermark&quot;:null,&quot;fullscreen&quot;:null,&quot;imageSize&quot;:null,&quot;height&quot;:970,&quot;width&quot;:1456,&quot;resizeWidth&quot;:null,&quot;bytes&quot;:153658,&quot;alt&quot;:null,&quot;title&quot;:null,&quot;type&quot;:&quot;image/jpeg&quot;,&quot;href&quot;:&quot;https://www.pexels.com/photo/empty-test-tubes-on-racks-8539653/&quot;,&quot;belowTheFold&quot;:false,&quot;topImage&quot;:true,&quot;internalRedirect&quot;:null,&quot;isProcessing&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" class="sizing-normal" alt="" srcset="https://substackcdn.com/image/fetch/$s_!idv0!,w_424,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F6de3f6e6-e7c6-4918-a92a-f92f2d51f6ef_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!idv0!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F6de3f6e6-e7c6-4918-a92a-f92f2d51f6ef_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!idv0!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F6de3f6e6-e7c6-4918-a92a-f92f2d51f6ef_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!idv0!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F6de3f6e6-e7c6-4918-a92a-f92f2d51f6ef_1880x1253.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by https://kaboompics.com/ on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>Amgen has registered a Phase 3 trial, not yet recruiting, to compare maridebart cafraglutide with semaglutide in people with type 2 diabetes, planned to start on November 2, 2026.</h6></li><li><h6>A separate recruiting trial is testing whether a ketogenic diet can ease high blood sugar caused by pasireotide, a second-line treatment for acromegaly.</h6></li></ul></div><p>Amgen has registered a Phase 3 trial that will test its investigational drug maridebart cafraglutide against semaglutide in people with type 2 diabetes, though the study has not yet begun. The record was updated on October 8, 2026. A second trial updated the same day looks at a different problem: managing high blood sugar linked to pasireotide, an acromegaly medication.</p><p>Amgen's trial, updated on October 8, 2026, is a Phase 3 study comparing maridebart cafraglutide with semaglutide in people with type 2 diabetes who are receiving metformin, with or without an SGLT-2 inhibitor. ClinicalTrials.gov lists it as not yet recruiting, with a planned start date of November 2, 2026, and a planned enrollment of 1,300 people. The main objective is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control. Because the study has not opened for enrollment, there are no results to report.</p><p>The second trial, sponsored by Leiden University Medical Center and also updated on October 8, 2026, is recruiting participants. It is testing whether a ketogenic diet can reduce high blood sugar caused by pasireotide, a second-line treatment for acromegaly. The trial compares a ketogenic diet with standard care and does not specify which diabetes medication is used. It plans to enroll 30 people. As a recruiting study, it has not yet reported results.</p><p>Neither of these trials has results yet. The Amgen trial is planned to start on November 2, 2026, and the pasireotide study is already recruiting. The trial records on ClinicalTrials.gov list the details for each study.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-09">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[UBT251 triple agonist shows weight reduction in phase 2 trial]]></title><description><![CDATA[The multicenter, randomized trial in adults with overweight or obesity was published in Cell Metabolism.]]></description><link>https://newsletter.glp1studio.com/p/ubt251-triple-agonist-shows-weight</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/ubt251-triple-agonist-shows-weight</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Thu, 08 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/9079ff40-5a47-4d26-b1ab-f47e7efa10d2_1880x1058.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/a-person-holding-a-syringe-and-a-vial-8533059/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!YMuz!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9079ff40-5a47-4d26-b1ab-f47e7efa10d2_1880x1058.jpeg 424w, https://substackcdn.com/image/fetch/$s_!YMuz!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9079ff40-5a47-4d26-b1ab-f47e7efa10d2_1880x1058.jpeg 848w, https://substackcdn.com/image/fetch/$s_!YMuz!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9079ff40-5a47-4d26-b1ab-f47e7efa10d2_1880x1058.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!YMuz!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9079ff40-5a47-4d26-b1ab-f47e7efa10d2_1880x1058.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!YMuz!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9079ff40-5a47-4d26-b1ab-f47e7efa10d2_1880x1058.jpeg" width="1456" height="819" 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https://substackcdn.com/image/fetch/$s_!YMuz!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9079ff40-5a47-4d26-b1ab-f47e7efa10d2_1880x1058.jpeg 848w, https://substackcdn.com/image/fetch/$s_!YMuz!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9079ff40-5a47-4d26-b1ab-f47e7efa10d2_1880x1058.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!YMuz!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9079ff40-5a47-4d26-b1ab-f47e7efa10d2_1880x1058.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by Artem Podrez on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>UBT251, a GLP-1, GIP and glucagon receptor agonist, produced weight reduction in a phase 2 trial, and the authors say the results support phase 3 evaluation.</h6></li></ul></div><p>A study of UBT251 was published in Cell Metabolism, with the tracker's latest record dated October 7, 2026. It was a multicenter, randomized phase 2 trial in adults with overweight or obesity. UBT251 is a triple GLP-1, GIP and glucagon receptor agonist. The study authors say the results support phase 3 evaluation.</p><p>UBT251 is described as a novel agonist of three receptors: GLP-1, GIP and glucagon. According to the published record, UBT251 produced weight reduction with cardiometabolic improvements and an acceptable safety profile in adults with overweight or obesity. The authors say the results support phase 3 evaluation.</p><p>This is a phase 2 trial, and the study supports phase 3 evaluation. The record gives no approval information, so UBT251 should not be considered an approved drug. If you have questions about how a new drug like this might fit into your own treatment, that conversation belongs with your doctor.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-08">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[A pill version of GLP-1 drugs just matched a standard diabetes drug]]></title><description><![CDATA[The same week FDA posted warning letters to two online sellers of unapproved semaglutide.]]></description><link>https://newsletter.glp1studio.com/p/a-pill-version-of-glp-1-drugs-just</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/a-pill-version-of-glp-1-drugs-just</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Wed, 07 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/053e99e1-f309-4652-aaf0-b505328b500d_1880x1255.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/empty-orange-cup-lying-down-on-ground-20307176/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!n175!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F053e99e1-f309-4652-aaf0-b505328b500d_1880x1255.jpeg 424w, https://substackcdn.com/image/fetch/$s_!n175!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F053e99e1-f309-4652-aaf0-b505328b500d_1880x1255.jpeg 848w, https://substackcdn.com/image/fetch/$s_!n175!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F053e99e1-f309-4652-aaf0-b505328b500d_1880x1255.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!n175!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F053e99e1-f309-4652-aaf0-b505328b500d_1880x1255.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!n175!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F053e99e1-f309-4652-aaf0-b505328b500d_1880x1255.jpeg" width="1456" height="972" 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https://substackcdn.com/image/fetch/$s_!n175!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F053e99e1-f309-4652-aaf0-b505328b500d_1880x1255.jpeg 848w, https://substackcdn.com/image/fetch/$s_!n175!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F053e99e1-f309-4652-aaf0-b505328b500d_1880x1255.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!n175!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F053e99e1-f309-4652-aaf0-b505328b500d_1880x1255.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by Chris F on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>A new phase 4 trial will test semaglutide alongside coaching for 880 people in Canada with obesity and advanced kidney disease, a group often kept off transplant lists, starting January 2027.</h6></li><li><h6>FDA sent Cheap Medicine Shop a warning letter on September 24 for selling unapproved and misbranded semaglutide sold as Semanext Injection.</h6></li><li><h6>FDA sent Online Generic Medicine a warning letter for selling unapproved and misbranded semaglutide sold as Semanat Injection.</h6></li><li><h6>A phase 3 study found the oral GLP-1 pill safiglipron works as well as dapagliflozin for type 2 diabetes when metformin alone isn't enough.</h6></li></ul></div><p>The past few weeks brought a mix of encouraging research and necessary warnings for anyone following GLP-1 drugs. A new oral option showed it can hold its own against an established diabetes medication, while FDA warning letters dated September 23 and 24 went to two online sellers of unapproved semaglutide. Together, these updates point to the same lesson: real progress on GLP-1 treatments is happening through legitimate trials and approved channels, not through unregulated online sellers. That distinction matters if you're considering any GLP-1 medication for yourself or a family member.</p><p>People with obesity and advanced kidney disease often face an added hurdle: many transplant programs set weight-related criteria before they will add someone to the transplant list. The upcoming phase 4 trial in Canada will examine whether semaglutide, combined with virtual coaching, can help patients meet those criteria and move toward transplantation. Enrollment of 880 participants is set to begin in January 2027, which means results will not be available for some time. For patients and families hoping to get on a transplant list, this trial signals that researchers are looking specifically at how GLP-1 drugs might support this group, though no conclusions can be drawn until the study is complete.</p><p>The FDA's warning letter to Cheap Medicine Shop, dated September 24, addresses a problem that has become familiar: online sellers offering semaglutide without the approvals that ensure a drug's safety and quality. The letter names one product sold as Semanext Injection. Unlike pharmacies that operate within FDA oversight, these unlicensed sellers aren't required to prove their products contain the correct ingredients in the correct amounts. That gap creates real risk, since buyers have no way to confirm whether what they receive is counterfeit or contaminated. Anyone considering a GLP-1 medication should treat the source of that medication as seriously as the decision to take it at all.</p><p>A second warning letter, dated September 23, went to Online Generic Medicine for selling unapproved and misbranded semaglutide sold as Semanat Injection, a name that does not belong to any FDA-approved product. An unfamiliar brand name like this can make a product look legitimate to someone searching for a known medication. The FDA said unapproved semaglutide products like these carry risks because the agency has not reviewed them for safety, quality or effectiveness. The two letters, sent a day apart, suggest the FDA is actively tracking multiple sellers rather than responding to a single isolated case. A warning letter is a formal notice, not a shutdown; the FDA can take further action if a seller does not fix the problems. Patients who have purchased semaglutide online, particularly from unfamiliar brands, may want to check whether that seller has appeared in an FDA warning before continuing to use the product.</p><p>The phase 3 trial results for safiglipron offer a different kind of update, focused on expanding treatment options rather than policing bad actors. In this study, the oral pill performed as well as dapagliflozin, an established type 2 diabetes drug, for patients whose blood sugar wasn't adequately controlled by metformin alone. Because safiglipron is taken as a pill rather than injected, a result like this could matter for patients who prefer or need an oral option. The study was randomized, double-blind, and compared directly against an active treatment rather than a placebo, which strengthens confidence in the comparison.</p><p>If you're exploring GLP-1 treatment, the clearest takeaway from these updates is to rely on two things: your prescribing physician and FDA-approved sources for the medication itself. Research into new formulations and new patient groups continues to move forward through proper trials, and that progress is worth watching. But none of it changes the risk posed by unlicensed online sellers, who remain a separate and ongoing problem. Staying informed about both tracks, the legitimate research and the regulatory warnings, will serve you better than following either one alone.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-07">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[Five new semaglutide trials in Egypt focus on bariatric surgery]]></title><description><![CDATA[If weight comes back after bariatric surgery, researchers are finally testing what actually helps next.]]></description><link>https://newsletter.glp1studio.com/p/six-semaglutide-trials-are-opening</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/six-semaglutide-trials-are-opening</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Tue, 06 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/4fd8e5b9-9957-414d-b75d-5981f706586d_1880x1058.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/surgeons-in-an-operating-room-17468307/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!hG8w!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4fd8e5b9-9957-414d-b75d-5981f706586d_1880x1058.jpeg 424w, https://substackcdn.com/image/fetch/$s_!hG8w!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4fd8e5b9-9957-414d-b75d-5981f706586d_1880x1058.jpeg 848w, https://substackcdn.com/image/fetch/$s_!hG8w!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4fd8e5b9-9957-414d-b75d-5981f706586d_1880x1058.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!hG8w!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4fd8e5b9-9957-414d-b75d-5981f706586d_1880x1058.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!hG8w!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4fd8e5b9-9957-414d-b75d-5981f706586d_1880x1058.jpeg" width="1456" height="819" data-attrs="{&quot;src&quot;:&quot;https://substack-post-media.s3.amazonaws.com/public/images/4fd8e5b9-9957-414d-b75d-5981f706586d_1880x1058.jpeg&quot;,&quot;srcNoWatermark&quot;:null,&quot;fullscreen&quot;:null,&quot;imageSize&quot;:null,&quot;height&quot;:819,&quot;width&quot;:1456,&quot;resizeWidth&quot;:null,&quot;bytes&quot;:188371,&quot;alt&quot;:null,&quot;title&quot;:null,&quot;type&quot;:&quot;image/jpeg&quot;,&quot;href&quot;:&quot;https://www.pexels.com/photo/surgeons-in-an-operating-room-17468307/&quot;,&quot;belowTheFold&quot;:false,&quot;topImage&quot;:true,&quot;internalRedirect&quot;:null,&quot;isProcessing&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" class="sizing-normal" alt="" srcset="https://substackcdn.com/image/fetch/$s_!hG8w!,w_424,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4fd8e5b9-9957-414d-b75d-5981f706586d_1880x1058.jpeg 424w, https://substackcdn.com/image/fetch/$s_!hG8w!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4fd8e5b9-9957-414d-b75d-5981f706586d_1880x1058.jpeg 848w, https://substackcdn.com/image/fetch/$s_!hG8w!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4fd8e5b9-9957-414d-b75d-5981f706586d_1880x1058.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!hG8w!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F4fd8e5b9-9957-414d-b75d-5981f706586d_1880x1058.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by Turan Kaymaz on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>Amneal recalled one lot (AP250095A) of its generic exenatide pens because some may be empty; if you have that lot, ask your pharmacy for a replacement.</h6></li><li><h6>A kidney disease trial testing semaglutide, open since 2024, continues to recruit in Australia, India, New Zealand, Spain and Sri Lanka.</h6></li><li><h6>A trial opening in October 2026 will test semaglutide specifically for people who regained weight after bariatric surgery.</h6></li><li><h6>Another trial will study semaglutide given before and after converting a sleeve gastrectomy to gastric bypass for regained weight.</h6></li><li><h6>Another trial will test whether tapering semaglutide works better than stopping it all at once, after it was used to treat weight regain following surgery.</h6></li></ul></div><p>Eight GLP-1 developments were tracked on Tuesday, October 6, 2026, and most of them share one theme: what happens when weight comes back after bariatric surgery. One item is a safety recall that requires immediate action. Most of the others are trials, including five new studies in Egypt set to open in October 2026, built specifically around people whose surgery results have faded. If you have had bariatric surgery or take semaglutide for another condition, several of these developments may apply directly to you.</p><p>Amneal has recalled one lot of its generic Exenatide Injection USP prefilled pens, lot AP250095A with an expiration date of February 28, 2027, because some pens may contain no medication at all. This is Amneal's generic exenatide, not the brand Byetta. The pens carry NDC 70121-1685-1, manufactured by Amneal Pharmaceuticals in India and distributed by Amneal Pharmaceuticals LLC in Bridgewater, New Jersey. If you use this product, I would suggest checking your pen's lot number right away. If you have that lot, ask your pharmacy for a replacement. An empty pen will not deliver the dose you expect, which could leave a gap in your treatment without warning.</p><p>A large international trial, structured as an adaptive platform study and open since 2024, continues to recruit people with chronic kidney disease in Australia, India, New Zealand, Spain and Sri Lanka to test whether semaglutide can slow the damage the disease causes. The trial is testing semaglutide both on its own and in combination with other drugs, which allows researchers to compare several treatment approaches within the same study. This design is meant to produce answers more efficiently than running separate trials for each combination. If you have chronic kidney disease, this trial may be worth discussing with your doctor, since it is open in those five countries and is currently in Phase 3.</p><p>A separate trial in Egypt, called RESURGE, is aimed directly at people who lost weight after bariatric surgery and then gained some of it back. The study will test semaglutide at the 2.4 mg weekly dose specifically in this group, rather than in people trying GLP-1 drugs for the first time. It is currently listed as not yet recruiting, with enrollment expected to begin in October 2026. This is a Phase 4 trial, meaning the drug is already approved and the research is focused on how it performs in real-world use after surgery has already been tried once.</p><p>Another Phase 4 trial will look at a more complicated situation: patients who had a sleeve gastrectomy, regained weight, and are now having that surgery converted to a Roux-en-Y gastric bypass. Researchers will give semaglutide both before and after the conversion procedure, rather than just afterward. The goal is to see whether adding the drug around the time of a second surgery produces better results than the surgery alone. This trial is also set to open in October 2026 and has not yet begun recruiting participants.</p><p>A fifth trial addresses a practical question that comes up once semaglutide treatment ends: whether tapering the dose down slowly works better than stopping it all at once. Researchers will study this in people who were given semaglutide to treat weight regain or a weaker-than-expected result after bariatric surgery, comparing a gradual taper against abrupt discontinuation. The answer could shape how doctors advise patients to come off the drug once a course of treatment following surgery is complete. This trial, like the others, is not yet recruiting and is expected to open in October 2026.</p><p>If you use Amneal's generic exenatide pens, the most urgent step is to check for lot AP250095A and ask your pharmacy for a replacement if you have it. For everyone else, these trials represent a shift worth watching: researchers are building studies specifically around what happens after bariatric surgery stops producing the results it once did, rather than treating weight regain as an afterthought. If you have had bariatric surgery and are considering one of these trials, I would suggest talking with your surgeon or a study coordinator about eligibility before enrollment opens. Pay attention to whether a trial is recruiting now or expected to open in October 2026, since timing will affect when you can actually take part.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-06">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[FDA sends a warning letter to a major compounder of GLP-1 drugs]]></title><description><![CDATA[FDA says Empower Pharmacy's compounded semaglutide and tirzepatide appear to be copies of approved drugs. Empower has 15 working days to respond.]]></description><link>https://newsletter.glp1studio.com/p/fda-shuts-down-a-major-source-of</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/fda-shuts-down-a-major-source-of</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Mon, 05 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/7c2516cd-00af-4a1e-b64e-1d21372e488e_1880x1253.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/botox-flasks-on-doctor-hands-15688021/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!AgG1!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7c2516cd-00af-4a1e-b64e-1d21372e488e_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!AgG1!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7c2516cd-00af-4a1e-b64e-1d21372e488e_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!AgG1!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7c2516cd-00af-4a1e-b64e-1d21372e488e_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!AgG1!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7c2516cd-00af-4a1e-b64e-1d21372e488e_1880x1253.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!AgG1!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7c2516cd-00af-4a1e-b64e-1d21372e488e_1880x1253.jpeg" width="1456" height="970" data-attrs="{&quot;src&quot;:&quot;https://substack-post-media.s3.amazonaws.com/public/images/7c2516cd-00af-4a1e-b64e-1d21372e488e_1880x1253.jpeg&quot;,&quot;srcNoWatermark&quot;:null,&quot;fullscreen&quot;:null,&quot;imageSize&quot;:null,&quot;height&quot;:970,&quot;width&quot;:1456,&quot;resizeWidth&quot;:null,&quot;bytes&quot;:182475,&quot;alt&quot;:null,&quot;title&quot;:null,&quot;type&quot;:&quot;image/jpeg&quot;,&quot;href&quot;:&quot;https://www.pexels.com/photo/botox-flasks-on-doctor-hands-15688021/&quot;,&quot;belowTheFold&quot;:false,&quot;topImage&quot;:true,&quot;internalRedirect&quot;:null,&quot;isProcessing&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" class="sizing-normal" alt="" srcset="https://substackcdn.com/image/fetch/$s_!AgG1!,w_424,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7c2516cd-00af-4a1e-b64e-1d21372e488e_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!AgG1!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7c2516cd-00af-4a1e-b64e-1d21372e488e_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!AgG1!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7c2516cd-00af-4a1e-b64e-1d21372e488e_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!AgG1!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F7c2516cd-00af-4a1e-b64e-1d21372e488e_1880x1253.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by Jonathan Borba on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>FDA sent Empower Pharmacy a warning letter dated September 18, 2026, saying its compounded semaglutide and tirzepatide appear to be essentially copies of approved drugs. A warning letter is not an order to stop.</h6></li><li><h6>Federal prosecutors charged two men with conspiracy and smuggling over counterfeit Ozempic they allegedly sold to distributors in the US. The charges are allegations.</h6></li><li><h6>Health Canada recalled one lot of Apo-Semaglutide pens that may show and deliver a 0.25 mg or 0.5 mg dose instead of the expected 1 mg.</h6></li><li><h6>An FDA docket on which bulk drug substances compounding pharmacies may use has been open since 2015.</h6></li><li><h6>A phase 3 trial found retatrutide lowers weight and blood sugar in people with obesity and type 2 diabetes.</h6></li></ul></div><p>FDA sent a warning letter to Empower Pharmacy, one of the largest compounders of GLP-1 drugs, about its compounded semaglutide and tirzepatide. A warning letter is not an order to stop. It lists violations FDA says it found and gives the company 15 working days to respond. The letter arrived alongside federal charges against two men accused of distributing counterfeit Ozempic, a Canadian recall over a dosing error, and new trial data on next-generation weight loss drugs. Together, these updates matter because they affect where you can safely and legally get a GLP-1 medication, and at what cost.</p><p>Empower Pharmacy is one of the largest compounders of semaglutide and tirzepatide, and many patients priced out of branded GLP-1 drugs have used its products. FDA's September 18 warning letter follows a November 2025 inspection of its Houston facility. FDA says products such as tirzepatide with niacinamide and semaglutide with cyanocobalamin appear to be essentially copies of approved drugs, made regularly and in large amounts, and it cites problems with how the pharmacy makes sterile products. The letter does not order the company to stop. It asks Empower to respond in writing within 15 working days, and FDA says that not fixing the violations may lead to legal action such as seizure or injunction. If you fill a prescription through Empower, nothing in the letter cancels it today, but I would suggest asking your prescriber now what your options would be if that supply changes.</p><p>Federal prosecutors in the Middle District of Florida and the Justice Department charged two men with conspiracy and smuggling in an alleged scheme to distribute counterfeit Ozempic, and FDA's criminal investigators assisted. According to the indictment, the men obtained counterfeit Ozempic from unauthorized sources in China between July 2023 and April 2024 and sold it to co-conspirators and distributors in the United States at deep discounts, in packaging meant to fool pharmacies and patients further down the chain. An indictment is an allegation, and both men are presumed innocent. Counterfeit products can contain the wrong ingredients, the wrong dose, or no active medication at all, which makes them a safety risk separate from the questions around compounded drugs. If you buy a GLP-1 medication from a source outside your regular pharmacy or clinic, it is reasonable to ask for proof that the product came from an authorized distributor.</p><p>Health Canada recalled one lot of Apo-Semaglutide 4 mg pens, lot 7000636A, because the pen may show 0.25 mg or 0.5 mg in the dose window and deliver that amount instead of the expected 1 mg dose. That means a patient could get less medication than intended. The recall applies in Canada, so patients in the United States are not directly affected, but it is a reminder that problems with GLP-1 pens are not limited to any one country or product. If you use an injection pen, checking for recall notices tied to your specific lot number may be worth doing periodically.</p><p>FDA has kept a docket open since 2015 on which bulk drug substances compounding pharmacies may use under section 503A of federal drug law. That same law also lets a compounder use an ingredient that is part of an FDA-approved drug, which is how semaglutide and tirzepatide are compounded, so this list is one piece of a larger set of rules. Empower's warning letter rests on a different rule, the one that limits regularly compounding drugs that are essentially copies of approved products. Patients considering a compounded GLP-1 drug may want to know that the compounding rules are still being settled, along with the status of any single pharmacy.</p><p>A phase 3 trial called TRIUMPH-2 tested retatrutide in adults who have both obesity and type 2 diabetes, and the results showed reductions in both body weight and blood sugar. Retatrutide works on three hormone receptors rather than the one or two targeted by current GLP-1 drugs, which is part of why researchers are watching it closely as a possible next step in treatment. A separate trial of the same drug also reported improvement in sleep apnea and knee pain among people with obesity. These results support, though do not guarantee, a path toward FDA approval, and patients interested in newer options may want to ask their prescriber how clinical trial timelines affect when a drug like this could become available.</p><p>If you currently get semaglutide or tirzepatide through a compounding pharmacy, the most useful step is to ask your pharmacy whether your medication comes from Empower, since this warning letter names only that company. It is also worth asking your prescriber about FDA-approved alternatives and how their cost compares. Beyond your own prescription, keeping an eye on where a GLP-1 product came from, and confirming it was dispensed by a licensed pharmacy, remains a reasonable precaution given the counterfeit charges described above. None of this requires an immediate decision, but it does call for a conversation with whoever manages your prescription before your next refill is due.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-05">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[The FTC has proposed settlements with two major drug middlemen]]></title><description><![CDATA[Neither deal is final yet, and neither names GLP-1 drugs. Twenty states also raised concerns about Chinese-made ingredients in compounded GLP-1s.]]></description><link>https://newsletter.glp1studio.com/p/the-ftc-just-forced-two-major-drug</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/the-ftc-just-forced-two-major-drug</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Sun, 04 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/a823a5a6-efe6-418e-bb90-d36be9657313_1880x1253.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/variety-of-medicines-on-blister-packs-9742744/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!JjZc!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa823a5a6-efe6-418e-bb90-d36be9657313_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!JjZc!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa823a5a6-efe6-418e-bb90-d36be9657313_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!JjZc!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa823a5a6-efe6-418e-bb90-d36be9657313_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!JjZc!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa823a5a6-efe6-418e-bb90-d36be9657313_1880x1253.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!JjZc!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa823a5a6-efe6-418e-bb90-d36be9657313_1880x1253.jpeg" width="1456" height="970" data-attrs="{&quot;src&quot;:&quot;https://substack-post-media.s3.amazonaws.com/public/images/a823a5a6-efe6-418e-bb90-d36be9657313_1880x1253.jpeg&quot;,&quot;srcNoWatermark&quot;:null,&quot;fullscreen&quot;:null,&quot;imageSize&quot;:null,&quot;height&quot;:970,&quot;width&quot;:1456,&quot;resizeWidth&quot;:null,&quot;bytes&quot;:543525,&quot;alt&quot;:null,&quot;title&quot;:null,&quot;type&quot;:&quot;image/jpeg&quot;,&quot;href&quot;:&quot;https://www.pexels.com/photo/variety-of-medicines-on-blister-packs-9742744/&quot;,&quot;belowTheFold&quot;:false,&quot;topImage&quot;:true,&quot;internalRedirect&quot;:null,&quot;isProcessing&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" class="sizing-normal" alt="" srcset="https://substackcdn.com/image/fetch/$s_!JjZc!,w_424,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa823a5a6-efe6-418e-bb90-d36be9657313_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!JjZc!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa823a5a6-efe6-418e-bb90-d36be9657313_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!JjZc!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa823a5a6-efe6-418e-bb90-d36be9657313_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!JjZc!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fa823a5a6-efe6-418e-bb90-d36be9657313_1880x1253.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by SHVETS production on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>The FTC announced a proposed settlement with Express Scripts on February 4, 2026. It is not final, and the FTC's announcement names insulin, not GLP-1 drugs.</h6></li><li><h6>The FTC announced a proposed settlement with Caremark and Zinc Health Services on July 14, 2026. It is also not final, and it does not name GLP-1 drugs.</h6></li><li><h6>Twenty state attorneys general, including Tennessee's, wrote to Secretary of State Rubio in September 2026 about Chinese-sourced ingredients in compounded GLP-1 drugs, citing alleged ties to fentanyl precursor makers.</h6></li><li><h6>A February 2025 letter from 38 states and territories urged FDA to act against counterfeit GLP-1 drugs. It is older background, not a new action.</h6></li><li><h6>Pennsylvania Medicaid's GLP-1 spending and prescription counts dropped sharply in early 2026, pointing to possible new coverage restrictions for patients there.</h6></li></ul></div><p>Federal regulators and state officials each took steps on different parts of the system that shapes GLP-1 access. The FTC has proposed settlements with two major pharmacy benefit managers, and neither is final yet. Twenty state attorneys general raised concerns with the Secretary of State about Chinese-made ingredients in compounded GLP-1 drugs, and new Medicaid data showed Pennsylvania's GLP-1 prescriptions falling sharply. Together, these moves bear on what you pay, what you receive, and whether your coverage holds.</p><p>Express Scripts acts as a middleman between insurers and pharmacies, negotiating which drugs get covered and at what price. On February 4, 2026, the FTC announced a proposed settlement with the company. The FTC voted to accept it for public comment, and it becomes a final order only after the Commission issues it on a final basis. Under the proposal, Express Scripts would base members' out-of-pocket costs on a drug's net cost rather than its list price, stop favoring high list price versions of a drug over identical lower-cost versions, and give plan sponsors more detail on pricing. The FTC's announcement focuses on insulin and does not mention GLP-1 drugs, so it is too early to say whether your GLP-1 costs will change. I would suggest checking with your pharmacy or insurer before expecting any difference at the pharmacy counter.</p><p>Caremark is the second major pharmacy middleman to reach a proposed settlement with the FTC this year. The July 14, 2026 proposal, with Caremark Rx and Zinc Health Services, was also accepted for public comment and is not final. It would require that members' out-of-pocket costs be no higher than the plan sponsor's contracted rate minus rebates, more pricing transparency for plan sponsors, and programs that cap what members pay for insulin. The FTC's announcement does not mention GLP-1 drugs. With two proposed settlements, the FTC appears to be treating pharmacy benefit managers as a central target in its effort to lower drug costs.</p><p>Tennessee Attorney General Skrmetti joined 19 other state attorneys general in a September 2026 letter to Secretary of State Marco Rubio about Chinese-sourced ingredients used in compounded GLP-1 drugs. The letter cites reports that some Chinese companies tied to fentanyl precursors are now selling weight-loss peptides, and it criticizes an FDA list of approved suppliers that the states say lets Chinese suppliers ship products without detention or inspection. These are concerns and allegations the states raised in a letter. Patients who buy GLP-1 drugs outside of a licensed pharmacy have no way to verify where the product came from or what it contains.</p><p>A larger coalition of 38 states and territories, co-led by Colorado, South Carolina, Illinois and Tennessee and joined by California, wrote to FDA in February 2025 urging faster action against counterfeit GLP-1 drugs, against online sellers of the active ingredients, and against compounders that cut corners. That letter is more than a year and a half old, so it is background rather than a new action. Its size shows that counterfeit GLP-1 drugs have been a concern across political and regional lines for some time.</p><p>Pennsylvania Medicaid spent $69.4 million on 68,509 GLP-1 prescriptions in the first quarter of 2026, down from $254.9 million in the last quarter of 2025, a decline that mirrors patterns in other states this year. In New Hampshire, Medicaid prescriptions for the weight-loss drugs Wegovy, Zepbound and Saxenda fell 88 percent over the same period, and in Puerto Rico they fell from 8,798 to none reported. These numbers suggest that some state Medicaid programs have narrowed coverage of GLP-1 drugs for weight loss rather than simply seeing less demand. Pennsylvania patients currently covered through Medicaid may want to confirm their coverage status directly with their plan.</p><p>The throughline across these developments is that drug pricing and drug safety are both being contested right now, through proposed federal settlements, state letters, and shifting Medicaid budgets. If you fill a GLP-1 prescription through Express Scripts or Caremark, these proposals do not change your costs today, and it is worth watching whether they become final. If you are considering a GLP-1 drug from a source outside your regular pharmacy, take the attorneys general's warnings about counterfeit and unregulated supply chains seriously and verify the source before you buy. None of these changes stem from one single action, but each shapes a different piece of what you pay and what you receive, and a short conversation with your pharmacist or insurer can clarify where you currently stand.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-04">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[Two trials test switching from one weight-loss drug to another]]></title><description><![CDATA[Boehringer Ingelheim will enroll 350 adults without diabetes, some new to GLP-1 drugs and some switching from one, while Novo Nordisk checks if switching to its newer drug is safe.]]></description><link>https://newsletter.glp1studio.com/p/two-drug-makers-test-what-happens</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/two-drug-makers-test-what-happens</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Sat, 03 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/d1697faa-ccb6-4d6a-b302-8553f57b3e9d_1880x1253.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/white-and-red-candy-cane-on-pink-and-white-heart-shaped-paper-6942177/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!Zyws!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fd1697faa-ccb6-4d6a-b302-8553f57b3e9d_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!Zyws!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fd1697faa-ccb6-4d6a-b302-8553f57b3e9d_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!Zyws!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fd1697faa-ccb6-4d6a-b302-8553f57b3e9d_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!Zyws!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fd1697faa-ccb6-4d6a-b302-8553f57b3e9d_1880x1253.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!Zyws!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fd1697faa-ccb6-4d6a-b302-8553f57b3e9d_1880x1253.jpeg" width="1456" height="970" data-attrs="{&quot;src&quot;:&quot;https://substack-post-media.s3.amazonaws.com/public/images/d1697faa-ccb6-4d6a-b302-8553f57b3e9d_1880x1253.jpeg&quot;,&quot;srcNoWatermark&quot;:null,&quot;fullscreen&quot;:null,&quot;imageSize&quot;:null,&quot;height&quot;:970,&quot;width&quot;:1456,&quot;resizeWidth&quot;:null,&quot;bytes&quot;:303202,&quot;alt&quot;:null,&quot;title&quot;:null,&quot;type&quot;:&quot;image/jpeg&quot;,&quot;href&quot;:&quot;https://www.pexels.com/photo/white-and-red-candy-cane-on-pink-and-white-heart-shaped-paper-6942177/&quot;,&quot;belowTheFold&quot;:false,&quot;topImage&quot;:true,&quot;internalRedirect&quot;:null,&quot;isProcessing&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" class="sizing-normal" alt="" srcset="https://substackcdn.com/image/fetch/$s_!Zyws!,w_424,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fd1697faa-ccb6-4d6a-b302-8553f57b3e9d_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!Zyws!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fd1697faa-ccb6-4d6a-b302-8553f57b3e9d_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!Zyws!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fd1697faa-ccb6-4d6a-b302-8553f57b3e9d_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!Zyws!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fd1697faa-ccb6-4d6a-b302-8553f57b3e9d_1880x1253.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by Nataliya Vaitkevich on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>A Novo Nordisk phase 1 trial starting fall 2026 will test whether switching from semaglutide to zenagamtide is safe for 60 people.</h6></li><li><h6>Boehringer Ingelheim will enroll 350 people without diabetes starting November 2026 to test survodutide, a new weight-loss injection, in people new to GLP-1 drugs and people switching from one.</h6></li></ul></div><p>Two new trials, tracked on October 3, 2026, look at what comes after semaglutide. One asks whether people already on the drug can switch to something newer without problems. The other tests a different injection in people new to GLP-1 drugs and in people switching from one. If you take semaglutide now or are considering a GLP-1 for weight loss, both studies could shape what options you have later.</p><p>Novo Nordisk's phase 1 trial, set to begin in fall 2026, will enroll 60 adults with overweight or obesity, with or without type 2 diabetes, who are currently taking semaglutide. The study asks a narrow but practical question: can these patients move to zenagamtide, a newer GLP-1 drug, safely? This matters because many people on semaglutide eventually look for an alternative, and right now there is little formal data on what switching does to tolerability or side effects. A phase 1 study of this size will not settle the question on its own. It should offer early signals on whether a planned transition between these two drugs is reasonable to study further in larger trials.</p><p>Boehringer Ingelheim's trial, called SYNCHRONIZE-START, takes a different approach. Starting in November 2026, the company will enroll 350 people with overweight or obesity who do not have diabetes, some new to GLP-1 drugs and some switching from one. This is a phase 3 study, meaning survodutide has already moved past early safety testing and is now being evaluated at a scale closer to what the FDA would need for approval. Because the trial has two groups, one starting survodutide as a first treatment and one switching to it from another GLP-1 drug, it should show how the drug performs both ways.</p><p>These two trials are tracking different questions, and the answers will not arrive at the same time or in the same way. If you are on semaglutide and wondering about switching, the Novo trial is the one to watch, though phase 1 data takes time to mature. The Boehringer trial may eventually tell you more about survodutide, whether you are new to GLP-1 drugs or thinking about switching. In either case, I would suggest waiting for published results before changing your treatment plan, and talking with your prescriber about what these trials could mean for you.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-03">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[New trials test a kidney drug with semaglutide and an enzyme for diabetes]]></title><description><![CDATA[One pairs finerenone with semaglutide for obesity and kidney disease; the other tests a digestive enzyme in people with diabetes who are not on GLP-1 drugs.]]></description><link>https://newsletter.glp1studio.com/p/two-new-trials-pair-glp-1-drugs-with</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/two-new-trials-pair-glp-1-drugs-with</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Fri, 02 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/ff90aebc-3bfe-4789-86da-6fafd9a05691_1880x1253.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/woman-working-in-chemistry-lab-8539892/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!h33O!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fff90aebc-3bfe-4789-86da-6fafd9a05691_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!h33O!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fff90aebc-3bfe-4789-86da-6fafd9a05691_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!h33O!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fff90aebc-3bfe-4789-86da-6fafd9a05691_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!h33O!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fff90aebc-3bfe-4789-86da-6fafd9a05691_1880x1253.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!h33O!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fff90aebc-3bfe-4789-86da-6fafd9a05691_1880x1253.jpeg" width="1456" height="970" data-attrs="{&quot;src&quot;:&quot;https://substack-post-media.s3.amazonaws.com/public/images/ff90aebc-3bfe-4789-86da-6fafd9a05691_1880x1253.jpeg&quot;,&quot;srcNoWatermark&quot;:null,&quot;fullscreen&quot;:null,&quot;imageSize&quot;:null,&quot;height&quot;:970,&quot;width&quot;:1456,&quot;resizeWidth&quot;:null,&quot;bytes&quot;:172429,&quot;alt&quot;:null,&quot;title&quot;:null,&quot;type&quot;:&quot;image/jpeg&quot;,&quot;href&quot;:&quot;https://www.pexels.com/photo/woman-working-in-chemistry-lab-8539892/&quot;,&quot;belowTheFold&quot;:false,&quot;topImage&quot;:true,&quot;internalRedirect&quot;:null,&quot;isProcessing&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" class="sizing-normal" alt="" srcset="https://substackcdn.com/image/fetch/$s_!h33O!,w_424,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fff90aebc-3bfe-4789-86da-6fafd9a05691_1880x1253.jpeg 424w, https://substackcdn.com/image/fetch/$s_!h33O!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fff90aebc-3bfe-4789-86da-6fafd9a05691_1880x1253.jpeg 848w, https://substackcdn.com/image/fetch/$s_!h33O!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fff90aebc-3bfe-4789-86da-6fafd9a05691_1880x1253.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!h33O!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fff90aebc-3bfe-4789-86da-6fafd9a05691_1880x1253.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by https://kaboompics.com/ on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>A new China trial, not yet recruiting, will test in 266 people whether pairing finerenone with semaglutide helps people with obesity and kidney disease who don't have diabetes.</h6></li><li><h6>A Phase 4 trial in Poland is recruiting 100 people with type 2 diabetes who are not on GLP-1 drugs to test whether pancreatin, a digestive enzyme, improves blood sugar.</h6></li></ul></div><p>One new clinical trial asks whether semaglutide works better with a partner drug than it does alone, and another tests a digestive enzyme for blood sugar. The first, not yet recruiting in China, will pair semaglutide with a kidney drug for people with obesity who do not have diabetes. The other, in Poland, is recruiting people with type 2 diabetes who are not taking GLP-1 drugs to test a digestive enzyme supplement. If you take a GLP-1 drug, these trials point to where research is heading next.</p><p>The China trial focuses on a specific group: adults with obesity and chronic kidney disease with albuminuria who do not have diabetes. Finerenone is a drug used to protect the kidneys, and researchers in this 266-person, placebo-controlled study want to know if combining it with semaglutide from the start works better than semaglutide alone for this population. The trial has not yet begun recruiting, so there are no results to review and no timeline for when participants will be enrolled. For people managing both obesity and kidney disease, this is a study worth watching as it moves toward recruitment, since it targets a combination that has not been tested together in this way.</p><p>The pancreatin trial is further along and is now recruiting 100 people with type 2 diabetes in Poland. Pancreatin is a digestive enzyme supplement, and this phase 4 trial will test whether adding it to standard diabetes medicines improves blood sugar control compared with a placebo. People taking GLP-1 drugs now or in the last three months are not eligible. Researchers are interested in pancreatin partly because it may raise the body's own levels of GLP-1 and GIP, the hormones these drugs copy. Phase 4 trials study products already on the market, so the focus here is on a new use for an existing enzyme rather than a new medication. People with type 2 diabetes who are not on a GLP-1 drug can look up the trial listing for eligibility details and enrollment status.</p><p>Neither trial has produced results yet, so there is nothing here to act on directly. What these two studies show is that researchers are testing whether semaglutide works better paired with a kidney drug, and whether a digestive enzyme can help blood sugar in people who are not on GLP-1 drugs. If you fall into either population, obesity with kidney disease or type 2 diabetes without GLP-1 therapy, it may be worth mentioning these trials to your doctor or checking back as they progress. Research like this takes time, and early recruitment status means real answers are still a way off.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-02">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item><item><title><![CDATA[Survodutide gets tested on menopause weight and liver disease at once]]></title><description><![CDATA[One drug, two 600-person trials, and a bet that GLP-1 competition will spread beyond diabetes and basic weight loss.]]></description><link>https://newsletter.glp1studio.com/p/survodutide-gets-tested-on-menopause</link><guid isPermaLink="false">https://newsletter.glp1studio.com/p/survodutide-gets-tested-on-menopause</guid><dc:creator><![CDATA[Amanda Bonello]]></dc:creator><pubDate>Thu, 01 Oct 2026 17:00:00 GMT</pubDate><enclosure url="https://substack-post-media.s3.amazonaws.com/public/images/97ec9866-4600-4f2e-9997-28f4e2920e65_1880x1255.jpeg" length="0" type="image/jpeg"/><content:encoded><![CDATA[<div class="captioned-image-container"><figure><a class="image-link image2 is-viewable-img" target="_blank" href="https://www.pexels.com/photo/scientist-inside-a-laboratory-8442538/" data-component-name="Image2ToDOM"><div class="image2-inset"><picture><source type="image/webp" srcset="https://substackcdn.com/image/fetch/$s_!lbtl!,w_424,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F97ec9866-4600-4f2e-9997-28f4e2920e65_1880x1255.jpeg 424w, https://substackcdn.com/image/fetch/$s_!lbtl!,w_848,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F97ec9866-4600-4f2e-9997-28f4e2920e65_1880x1255.jpeg 848w, https://substackcdn.com/image/fetch/$s_!lbtl!,w_1272,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F97ec9866-4600-4f2e-9997-28f4e2920e65_1880x1255.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!lbtl!,w_1456,c_limit,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F97ec9866-4600-4f2e-9997-28f4e2920e65_1880x1255.jpeg 1456w" sizes="100vw"><img src="https://substackcdn.com/image/fetch/$s_!lbtl!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F97ec9866-4600-4f2e-9997-28f4e2920e65_1880x1255.jpeg" width="1456" height="972" data-attrs="{&quot;src&quot;:&quot;https://substack-post-media.s3.amazonaws.com/public/images/97ec9866-4600-4f2e-9997-28f4e2920e65_1880x1255.jpeg&quot;,&quot;srcNoWatermark&quot;:null,&quot;fullscreen&quot;:null,&quot;imageSize&quot;:null,&quot;height&quot;:972,&quot;width&quot;:1456,&quot;resizeWidth&quot;:null,&quot;bytes&quot;:171025,&quot;alt&quot;:null,&quot;title&quot;:null,&quot;type&quot;:&quot;image/jpeg&quot;,&quot;href&quot;:&quot;https://www.pexels.com/photo/scientist-inside-a-laboratory-8442538/&quot;,&quot;belowTheFold&quot;:false,&quot;topImage&quot;:true,&quot;internalRedirect&quot;:null,&quot;isProcessing&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" class="sizing-normal" alt="" srcset="https://substackcdn.com/image/fetch/$s_!lbtl!,w_424,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F97ec9866-4600-4f2e-9997-28f4e2920e65_1880x1255.jpeg 424w, https://substackcdn.com/image/fetch/$s_!lbtl!,w_848,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F97ec9866-4600-4f2e-9997-28f4e2920e65_1880x1255.jpeg 848w, https://substackcdn.com/image/fetch/$s_!lbtl!,w_1272,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F97ec9866-4600-4f2e-9997-28f4e2920e65_1880x1255.jpeg 1272w, https://substackcdn.com/image/fetch/$s_!lbtl!,w_1456,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F97ec9866-4600-4f2e-9997-28f4e2920e65_1880x1255.jpeg 1456w" sizes="100vw" fetchpriority="high"></picture><div class="image-link-expand"><div class="pencraft pc-display-flex pc-gap-8 pc-reset"><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container restack-image buttonBase-GK1x3M"><svg aria-hidden="true" width="20" height="20" viewBox="0 0 20 20" fill="none" stroke-width="1.5" stroke="var(--color-fg-primary)" stroke-linecap="round" stroke-linejoin="round" xmlns="http://www.w3.org/2000/svg" class="icon-noB79L"><g><path d="M2.53001 7.81595C3.49179 4.73911 6.43281 2.5 9.91173 2.5C13.1684 2.5 15.9537 4.46214 17.0852 7.23684L17.6179 8.67647M17.6179 8.67647L18.5002 4.26471M17.6179 8.67647L13.6473 6.91176M17.4995 12.1841C16.5378 15.2609 13.5967 17.5 10.1178 17.5C6.86118 17.5 4.07589 15.5379 2.94432 12.7632L2.41165 11.3235M2.41165 11.3235L1.5293 15.7353M2.41165 11.3235L6.38224 13.0882"></path></g></svg></button><button tabindex="0" type="button" class="pencraft pc-reset pencraft icon-container view-image buttonBase-GK1x3M"><svg xmlns="http://www.w3.org/2000/svg" width="20" height="20" viewBox="0 0 24 24" fill="none" stroke="currentColor" stroke-width="2" stroke-linecap="round" stroke-linejoin="round" class="lucide lucide-maximize2 lucide-maximize-2 icon-noB79L"><polyline points="15 3 21 3 21 9"></polyline><polyline points="9 21 3 21 3 15"></polyline><line x1="21" x2="14" y1="3" y2="10"></line><line x1="3" x2="10" y1="21" y2="14"></line></svg></button></div></div></div></a><figcaption class="image-caption">Photo by Pavel Danilyuk on Pexels</figcaption></figure></div><div class="callout-block" data-callout="true"><h6>KEY DETAILS</h6><ul><li><h6>A new Phase 3 trial called SYNCHRONIZE-HERA will test whether survodutide helps women with obesity lose weight during or after menopause.</h6></li><li><h6>A separate Phase 3 trial, ELEVATE-LIVER, will enroll 600 people to see if survodutide improves heart structure and function in those with obesity and fatty liver disease.</h6></li></ul></div><p>Two new Phase 3 trials for survodutide, a GLP-1-like drug, were posted on Thursday, October 1, 2026. Together they test the drug in two different patient groups: women managing weight during or after menopause, and people with obesity and fatty liver disease. If you fall into either group, these trials may offer an early look at where GLP-1 treatment options are heading next. Neither trial is recruiting yet, but both are worth watching.</p><p>The SYNCHRONIZE-HERA trial is built around a question that general weight loss studies tend to skip over: whether a GLP-1-like drug works the same way for women during or after menopause as it does for other patients. Hormonal changes during this stage of life can affect how the body gains and holds onto weight, so testing survodutide specifically in this group is a meaningful departure from the usual trial design. The study has not opened for recruitment yet, so there is no enrollment information to act on right now. Still, if you are managing weight during or after menopause, this is a trial worth tracking as it moves toward recruitment, since it may eventually offer a treatment option designed with your situation in mind.</p><p>The ELEVATE-LIVER trial takes a different angle, enrolling 600 people with obesity and fatty liver disease to see whether survodutide improves heart structure and function. Pairing liver disease with heart outcomes in one study reflects how closely these conditions are linked in patients with obesity, and it suggests researchers want data on more than weight loss alone. A trial of this size, at 600 participants, is substantial enough to produce findings that could shape how survodutide is positioned if it reaches the market. As with the menopause trial, recruitment has not started, so there is nothing to sign up for yet. People living with obesity and fatty liver disease may want to keep an eye on this one, particularly if heart health is also a concern.</p><p>Neither trial is open for enrollment yet, so there is no action to take today beyond staying informed. I would suggest bookmarking both studies if either one applies to your situation, so you can check back as they move toward recruitment. It may also help to mention these trials to your doctor at your next visit, especially if you are weighing GLP-1 options for menopause-related weight changes or for fatty liver disease. These two trials are an early signal that GLP-1 competition is expanding past diabetes and general weight loss, but the decision about whether either path fits your care is one to make with your own medical team.</p><div><hr></div><p>Originally published on <a href="https://glp1laws.com/patient-lens/access-roundup-2026-10-01">GLP1Laws</a>.</p><p>Every Sunday, the weekly newsletter pulls the full week together: the news from <a href="https://glp1nation.com">GLP-1 Nation</a>, the access updates from <a href="https://glp1laws.com">GLP1Laws</a>, the latest <a href="https://glp1studio.substack.com/podcast">GLP-1 Studio podcast</a> episodes, and what changed in the <a href="https://cozybutter.com">Cozy Butter</a> community.</p>]]></content:encoded></item></channel></rss>