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

Trial ID or NCT#

NCT06318169

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Eligibility Criteria

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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).
    1. Key
Exclusion Criteria:
  1. * 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
    1. Other inclusion and exclusion criteria may apply.
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Investigator(s)

Paul Kwo
Paul Kwo
Hepatologist, Transplant hepatologist, Gastroenterologist
Professor of Medicine (Gastroenterology and Hepatology)

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Contact

ENLIGHTEN clinical trial
1-415-432-9270

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View on ClinicalTrials.gov