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A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
RecruitingPhase 3
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
Key Inclusion Criteria: * Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF). * Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors. * Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis. * Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2). Key Exclusion Criteria: * Liver disorder other than MASH. * History or evidence of hepatic decompensation. * History or evidence of hepatocellular carcinoma. * Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus. * 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 protocol-defined inclusion and exclusion criteria may apply.
About the study
The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).
What is being tested
- Pegozafermin (biological)
- Placebo (drug)
Sponsor: 89bio, Inc. · Participants: 762 · Started: May 24, 2024
Contact the study team
- Reference Study ID Number: BIO89-100-132 ENLIGHTEN clinical trial / No attachments to email below. · Phone: 888-662-6728 (U.S. Only)
Official record on ClinicalTrials.gov — NCT06419374
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.