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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Key Who May Qualify: - Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the willing to sign a consent form 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

Pegozafermin

Subcutaneous injection

OTHER

Placebo

Subcutaneous injection

Locations (20)

89bio Clinical Study Site
Birmingham, Alabama, United States
89bio Clinical Study Site
Chandler, Arizona, United States
89bio Clinical Study Site
Flagstaff, Arizona, United States
89bio Clinical Study Site
Glendale, Arizona, United States
89bio Clinical Study Site
Tucson, Arizona, United States
89bio Clinical Study Site
Conway, Arkansas, United States
89bio Clinical Study Site
Little Rock, Arkansas, United States
89bio Clinical Study Site
North Little Rock, Arkansas, United States
89bio Clinical Study Site
Canoga Park, California, United States
89bio Clinical Study Site
Coronado, California, United States
89bio Clinical Study Site
Fountain Valley, California, United States
89bio Clinical Study Site
Fresno, California, United States
89bio Clinical Study Site
Gardena, California, United States
89bio Clinical Study Site
Huntington Park, California, United States
89bio Clinical Study Site
Inglewood, California, United States
89bio Clinical Study Site
La Jolla, California, United States
89bio Clinical Study Site
Lancaster, California, United States
89bio Clinical Study Site
Long Beach, California, United States
89bio Clinical Study Site
Los Angeles, California, United States
89bio Clinical Study Site
Montclair, California, United States