Overview
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
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 evidence of hepatic decompensation.
- History or evidence of hepatocellular carcinoma.
- Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
- ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L).
- Participants taking vitamin E (\>400 international units \[IU\]/day) must be on stable dose for at least 6 months prior to screening.
Other protocol-defined inclusion and exclusion criteria may apply.
