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A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

Recruiting
18-75 years
All
Phase 3
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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).
  • At least 1 metabolic risk factor.
  • Biopsy-confirmed fibrosis stage F4 MASH (per non-alcoholic steatohepatitis [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 inclusion and exclusion criteria may apply.

Study details
    Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

NCT06419374

89bio, Inc.

23 May 2025

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