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: Biological: Pegozafermin; Other: Placebo

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

Brief Summary

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis \[NASH\]).

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: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-07
• Primary Completion: 2026-12
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

• Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF)
• Biopsy-confirmed MASH (previously named NASH) with fibrosis stage F2 or F3 per NASH CRN System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation (qualifying biopsy must be either within 6 months of screening visit [with additional requirements] or obtained during screening period)
• Body mass index (BMI) at screening ≥25.0 (≥23 for Asian participants) and <50.0 kilograms (kg)/meters squared (m^2)

Key

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Exclusion Criteria

• Chronic liver diseases other than MASH/NASH
• History or 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) 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 Regimen 1	Pegozafermin	-
Pegozafermin Regimen 2	Pegozafermin	-
Placebo	Placebo	Matched Placebo will be administered in Regimens 1 and 2.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With MASH/NASH Resolution Without Worsening of Fibrosis at Week 52	Week 52	Resolution of NASH 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.
Proportion of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of MASH/NASH at Week 52	Week 52	Worsening of NASH is defined as increase in NAFLD Activity Score (NAS) for ballooning, inflammation, or steatosis

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Alanine Aminotransferase (ALT) at Week 52 and Month 36	Baseline, Week 52
Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events	Up to Month 36
Change From Baseline in Liver Fat as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 52	Baseline, Week 52

Trial Locations

Locations (1)

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