2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/1855-ogyi8eh4.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/25a3ozcrvi1ff.js","/_next/static/immutable/chunks/2r4wx50nvjh_4.js","/_next/static/immutable/chunks/23fsw06hsi5b1.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/3ezsiz-7shkna.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2lxntcm3pd1_h.js","/_next/static/immutable/chunks/00dgco8irq3jw.js","/_next/static/immutable/chunks/00nwe-kq0rboc.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:T65d,Belapectin reduced variceal development in a subgroup of patients with MASH cirrhosis. We report the efficacy and safety of belapectin in patients with MASH cirrhosis and portal hypertension without varices at baseline. NAVIGATE was a global phase 2b trial. Patients were randomized to intravenous (i.v.) belapectin 2 or 4 mg/kg lean body weight or placebo for 18 months, stratified by type 2 diabetes. The primary endpoint was the incidence of varices with esophagogastroduodenoscopy (EGD) or a composite endpoint (new varices, intercurrent events, or discontinuation) at 18 months with belapectin versus placebo in the full analysis set (FAS). In a pre-specified analysis, new varices were evaluated in all patients who underwent EGD at baseline and 18 months. The per-protocol (PP) population was patients treated for 18 months with EGD at 18 months. Of 357 randomized patients, 291 completed treatment. Baseline characteristics were comparable across cohorts. In the FAS, 17.8% with placebo versus 10.1% with belapectin 2 mg/kg developed varices, a 43.2% reduction ( p =0.13). In the per-protocol population (PP), varices occurred in 22.3% with placebo versus 11.3% with belapectin 2 mg/kg, a 50% reduction (unadjusted p =0.04). Belapectin 4 mg/kg had no significant effect on variceal development. For the composite endpoint at 18 months, no significant difference was observed between belapectin 2 mg/kg ( p =0.14) or 4 mg/kg ( p =0.261) and placebo in the FAS. Belapectin was well-tolerated with no safety signals. Belapectin 2 mg/kg lowered the development of new varices in MASH cirrhosis and portal hypertension.31:T9a5, Background and Aims: Belapectin reduced variceal development in a subgroup of patients with MASH cirrhosis. We report the efficacy and safety of belapectin in patients with MASH cirrhosis and portal hypertension without varices at baseline. Approach and Results: NAVIGATE was a global phase 2b trial. Patients were randomized to intravenous (i.v.) belapectin 2 or 4 mg/kg lean body weight or placebo for 18 months, stratified by type 2 diabetes. The primary endpoint was the incidence of varices with esophagogastroduodenoscopy (EGD) or a composite endpoint (new varices, intercurrent events, or discontinuation) at 18 months with belapectin versus placebo in the full analysis set (FAS). In a pre-specified analysis, new varices were evaluated in all patients who underwent EGD at baseline and 18 months. The per-protocol (PP) population was patients treated for 18 months with EGD at 18 months. Of 357 randomized patients, 291 completed treatment. Baseline characteristics were comparable across cohorts. In the FAS, 17.8% with placebo versus 10.1% with belapectin 2 mg/kg developed varices, a 43.2% reduction ( p =0.13). In the per-protocol population (PP), varices occurred in 22.3% with placebo versus 11.3% with belapectin 2 mg/kg, a 50% reduction (unadjusted p =0.04). Belapectin 4 mg/kg had no significant effect on variceal development. For the composite endpoint at 18 months, no significant difference was observed between belapectin 2 mg/kg ( p =0.14) or 4 mg/kg ( p =0.261) and placebo in the FAS. Belapectin was well-tolerated with no safety signals. Conclusion: Belapectin 2 mg/kg lowered the development of new varices in MASH cirrhosis and portal hypertension. 25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"MASH Cirrhosis: condition Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on MASH Cirrhosis (condition). Clinician-written summaries and actionable practice insights. 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applied.","value_numeric":null},{"paper_doi":"10.1097/hep.0000000000001774","tag_type":"warning","value":"The full text body provided in the paper was a GI society statement on racism and social injustice, not the NAVIGATE trial manuscript — structured data were extracted solely from the abstract. Granular methodology, subgroup analyses, and safety details could not be verified from the full text.","value_numeric":null},{"paper_doi":"10.1097/hep.0000000000001774","tag_type":"warning","value":"The per-protocol population result (p=0.04) was a secondary/pre-specified analysis; the primary FAS endpoint did not achieve statistical significance (p=0.13). Impact flag set to 'limited_evidence' accordingly.","value_numeric":null}],"summaries":{"what_studied":"The NAVIGATE trial evaluated belapectin (2 mg/kg or 4 mg/kg IV lean body weight) versus placebo over 18 months for prevention of esophageal varices in patients with MASH cirrhosis and portal hypertension who had no varices at baseline (n=357 randomized).","key_result":"In the per-protocol population, belapectin 2 mg/kg reduced new variceal development by 50% vs. placebo (11.3% vs. 22.3%; unadjusted p=0.04). In the full analysis set, the reduction was 43.2% (10.1% vs. 17.8%) but did not reach significance (p=0.13). Belapectin 4 mg/kg showed no significant effect. The composite endpoint was not significantly different in either dose arm.","limitations":"- Primary endpoint in the full analysis set (FAS) did not reach statistical significance; the 50% reduction was only significant in the per-protocol population, a secondary analysis.\n- Phase 2b trial; underpowered to confirm efficacy definitively.\n- The full text provided was largely a GI society statement unrelated to the trial, limiting extraction of granular methodology and subgroup data.","practice_takeaway":"Belapectin 2 mg/kg may reduce new esophageal varix formation in MASH cirrhosis with portal hypertension, but results are not yet practice-changing — the primary endpoint missed significance. Clinicians should await phase 3 data before adopting this agent."}}],"initialOffset":1,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"condition","value":"MASH Cirrhosis"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Conditions","href":"/hub/tag/condition"},{"name":"MASH Cirrhosis"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"condition","hub_tag_value":"MASH Cirrhosis"}}}]]

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