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
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
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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 inclu…
Interventions
- DrugEfruxifermin
Administered by subcutaneous injection
- DrugPlacebo
Administered by subcutaneous injection
Locations (318)
- Akero Clinical Study SiteBirmingham, Alabama
- Akero Clinical Study SiteDothan, Alabama
- Akero Clinical Study SiteChandler, Arizona
- Akero Clinical Study SiteFlagstaff, Arizona
- Akero Clinical Study SitePeoria, Arizona
- Akero Clinical Study SiteScottsdale, Arizona