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A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
RECRUITINGPhase 3Sponsored by 89bio, Inc.
Actively Recruiting
PhasePhase 3
Sponsor89bio, Inc.
Started2024-03-13
Est. completion2029-02
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations135 sites
View on ClinicalTrials.gov →
NCT06318169
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
Age: 18 Years – 80 YearsHealthy volunteers accepted
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.
Conditions2
Liver DiseaseMetabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Interventions1
Locations135 sites
89bio Clinical Study Site
Birmingham, Alabama, 35209
89bio Clinical Study Site
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Actively Recruiting
PhasePhase 3
Sponsor89bio, Inc.
Started2024-03-13
Est. completion2029-02
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations135 sites
View on ClinicalTrials.gov →
NCT06318169