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

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

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 \[previously known as nonalcoholic steatohepatitis, NASH\]).

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 to 75

Participation Criteria

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 Location

89bio Clinical Study Site
89bio Clinical Study Site
Vancouver, British Columbia
Canada

Contact Study Team

Primary Contact

89bio Clinical Study Site

89bio Clinical Study Site
89bio Clinical Study Site
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

89bio Clinical Study Site

Study Sponsored By
89bio, Inc.
Participants Required
More Information
Study ID: NCT06419374