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Recruiting Phase 3 NCT06528314
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
Trial Parameters
Condition NASH - Nonalcoholic Steatohepatitis
Sponsor Akero Therapeutics, Inc
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 1,150
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2024-09-04
Completion 2029-09
All Conditions
Interventions
EfruxiferminPlacebo
Brief Summary
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/MASH.
Eligibility Criteria
Inclusion Criteria: * Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH * Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH Exclusion Criteria: * Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results * Type 1 diabetes or unstable Type 2 diabetes * Any current or prior history of decompensated liver disease Other inclusion and exclusion criteria may apply
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