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

89bio

Status and phase: Enrolling; Phase 3

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

Treatments: Biological: Pegozafermin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06419374

BIO89-100-132

Details and patient eligibility

About

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]).

Enrollment: 762 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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762 participants in 2 patient groups, including a placebo group

Pegozafermin

Experimental group

Treatment:

Biological: Pegozafermin

Placebo

Placebo Comparator group

Description:

Matched placebo

Treatment:

Drug: Placebo