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1809",{"type":3516,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100556685","phase-3-a-study-evaluating-efruxifermin-in-subjects-with-compensated-cirrhosis-due-to-nashmash-100556685",false,"NCT06528314","A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH\u002FMASH","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH\u002FMASH","Inclusion Criteria:\n\n* Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH\u002FMASH and NAS score of \\>=3 (at least 1 in each category) or evidence of steatosis and 2 current features of metabolic comorbidities\n* Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH\u002FMASH\n\nExclusion Criteria:\n\n* Other causes of liver disease based on medical history and\u002For liver histology and\u002For central laboratory results\n* Type 1 diabetes or unstable Type 2 diabetes\n* Any current or prior history of decompensated liver disease\n\nOther inclusion and exclusion criteria may apply.","ALL","18 Years","80 Years",{"count":3528,"type":3529},2150,"ESTIMATED","INTERVENTIONAL",[3532],"PHASE3","This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH\u002FMASH.",[3535,3536],"NASH - Nonalcoholic Steatohepatitis","MASH - Metabolic Dysfunction-Associated Steatohepatitis","2026-08-17",{"date":3539,"type":3540},"2026-08-19","ACTUAL",{"date":3542,"type":3540},"2024-09-04",{"date":3544,"type":3529},"2030-03",{"name":5,"class":6},329]