A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)
89bio, Inc.
Summary
The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF). * Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors. * Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis. * Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2). Key Exclusion Criteria: * Liver disorder other than MASH. * History or evide…
Interventions
- BiologicalPegozafermin
Subcutaneous injection
- DrugPlacebo
Subcutaneous injection
Locations (296)
- 89bio Clinical Study SiteBirmingham, Alabama
- 89bio Clinical Study SiteHomewood, Alabama
- 89bio Clinical Study SiteChandler, Arizona
- 89bio Clinical Study SiteFlagstaff, Arizona
- 89bio Clinical Study SitePeoria, Arizona
- 89bio Clinical Study SitePhoenix, Arizona