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NCT06318169
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 1350
Sponsor: 89bio, Inc.
Location: 89bio Clinical Study Site Birmingham Alabama
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06318169). StuddyBuddy aggregates publicly available trial information.
