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

Phase 3

Recruiting

• Conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
• Interventions: Biological: Pegozafermin; Drug: Placebo

• Registration Number: NCT06419374
• Lead Sponsor: 89bio, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-17
• Study Start: 2024-05-24
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06
• Primary Completion: 2028-06
• Study Completion: 2031-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 762

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pegozafermin	Pegozafermin	-
Placebo	Placebo	Matched placebo

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Achieving Fibrosis Regression	Baseline through Month 24	Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy.
Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events	Baseline through Month 60

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Enhanced Liver Fibrosis (ELF) Score	Baseline, Month 24 and Month 60
Change from Baseline in Alanine Aminotransferase (ALT) Level	Baseline, Month 24 and Month 60
Change from Baseline in FibroScan Vibration-controlled Transient Elastography (VCTE)	Baseline, Month 24 and Month 60
Proportion of Participants who Develop Clinically Significant Portal Hypertension (CSPH)	Baseline through Month 60

Trial Locations

Locations (1)

89bio Clinical Study Site; 🇨🇳 Kaohsiung, Taiwan