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.
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
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
Akero Therapeutics, Inc
Lead sponsor