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

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

Recruiting
18-80 years
All
Phase 3
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Overview

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.

Eligibility

Key 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 details
    Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

NCT06318169

89bio, Inc.

14 May 2026

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