A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
89bio, Inc.
Summary
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF) * Biopsy-confirmed MASH with fibrosis stage F2 or F3 * Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian participants). Key Exclusion Criteria: * Chronic liver diseases other than MASH * Evidence of cirrhosis on screening liver biopsy * Have type 1 diabetes or poorly controlled type 2 diabetes * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L) * Parti…
Interventions
- BiologicalPegozafermin
Subcutaneous injection
- OtherPlacebo
Subcutaneous injection
Locations (342)
- 89bio Clinical Study SiteBirmingham, Alabama
- 89bio Clinical Study SiteChandler, Arizona
- 89bio Clinical Study SiteFlagstaff, Arizona
- 89bio Clinical Study SiteGlendale, Arizona
- 89bio Clinical Study SiteTucson, Arizona
- 89bio Clinical Study SiteConway, Arkansas