Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH (ENLIGHTEN-Cirrhosis)

Phase 3

Recruiting

• Conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH) with Compensated Cirrhosis

• Registration Number: 2023-510395-31-00
• Lead Sponsor: 89bio Inc.

Brief Summary

At interim analysis: To evaluate the effect of pegozafermin compared to placebo on regression of fibrosis at 24 months relative to baseline biopsy.

At study completion: To evaluate the effect of pegozafermin compared to placebo in reducing the risk of clinical outcomes measured as a composite endpoint

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: 2025-10
• Last Update Submitted: 2025-10-01
• Last Update Posted: 2025-10-03
• Primary Completion: 2028-06
• Study Completion: 2031-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 155

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 up to 5 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

89bio Clinical Study Site; 🇬🇧 Southampton, United Kingdom