A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

Conditions: NASH - Nonalcoholic Steatohepatitis, MASH - Metabolic Dysfunction-Associated Steatohepatitis

Sex: All

Ages: 18 Years – 80 Years

Healthy volunteers: No

Phase: PHASE3

Enrollment: 2150

Sponsor: Akero Therapeutics, Inc

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 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06528314). StuddyBuddy aggregates publicly available trial information.