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A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
RecruitingPhase 3
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
Who can join
Ages 18 to 80 · All sexes
Full eligibility criteria
Inclusion Criteria: * Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH and NAS score of \>=3 (at least 1 in each category) or evidence of steatosis and 2 current features of metabolic comorbidities * 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.
About the study
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.
What is being tested
- Efruxifermin (drug)
- Placebo (drug)
Sponsor: Akero Therapeutics, Inc · Participants: 2,150 · Started: Sep 4, 2024
Contact the study team
- Akero Study Director · Phone: 650-487-6488
Official record on ClinicalTrials.gov — NCT06528314
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.