A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

Phase 3

Recruiting

• Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
• Interventions: Other: Placebo; Biological: Pegozafermin

• Registration Number: NCT06318169
• Lead Sponsor: 89bio, Inc.

Brief Summary

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-13
• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-19
• Status Verified: 2025-11
• Last Update Submitted: 2025-11-05
• Last Update Posted: 2025-11-06
• Primary Completion: 2029-02
• Study Completion: 2029-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1350

Inclusion Criteria

• Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
• Biopsy-confirmed MASH with fibrosis stage F2 or F3
• Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m^2) (≥23 kg/m^2 for Asian participants).

Key

Exclusion Criteria

• Chronic liver diseases other than MASH
• Evidence of cirrhosis on screening liver biopsy
• Have type 1 diabetes or poorly controlled type 2 diabetes
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)
• Participants taking vitamin E (>400 international units [IU]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening

Other inclusion and exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matched Placebo will be administered in Regimens 1 and 2.
Pegozafermin Regimen 1	Pegozafermin	-
Pegozafermin Regimen 2	Pegozafermin	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52	Week 52	Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis
Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52	Week 52	Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.
Time to First Occurrence of Disease Progression	Up to 5 years	Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events

Secondary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Alanine Aminotransferase at Week 52	Baseline, Week 52
Absolute Change From Baseline in Enhanced Liver Fibrosis (ELF) Score at Week 52	Baseline, Week 52

Trial Locations

Locations (2)

89bio_Clinical Study Site; 🇬🇪 Tbilisi, Georgia

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