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NCT06318169

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

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-13

Study Completion Date

2029-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Keywords

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Liver Diseases Fatty Liver Digestive System Diseases Metabolic diseases Metabolic Dysfunction-Associated Steatohepatitis MASH Steatohepatitis Metabolic dysfunction-associated steatotic liver disease MASLD Nonalcoholic fatty liver disease NAFLD Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pegozafermin Regimen 1

Group Type EXPERIMENTAL

Pegozafermin

Intervention Type BIOLOGICAL

Subcutaneous injection

Pegozafermin Regimen 2

Group Type EXPERIMENTAL

Pegozafermin

Intervention Type BIOLOGICAL

Subcutaneous injection

Placebo

Matched Placebo will be administered in Regimens 1 and 2.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subcutaneous injection

Interventions

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Pegozafermin

Subcutaneous injection

Intervention Type BIOLOGICAL

Placebo

Subcutaneous injection

Intervention Type OTHER

Other Intervention Names

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BIO89-100

Eligibility Criteria

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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).

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Millie Gottwald, PharmD

Role: STUDY_DIRECTOR

89bio, Inc.

Locations

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89bio Clinical Study Site

Birmingham, Alabama, United States

Site Status RECRUITING

89bio Clinical Study Site

Chandler, Arizona, United States

Site Status RECRUITING

89bio Clinical Study Site

Flagstaff, Arizona, United States

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89bio Clinical Study Site

Glendale, Arizona, United States

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89bio Clinical Study Site

Tucson, Arizona, United States

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89bio Clinical Study Site

Conway, Arkansas, United States

Site Status TERMINATED

89bio Clinical Study Site

Little Rock, Arkansas, United States

Site Status RECRUITING

89bio Clinical Study Site

North Little Rock, Arkansas, United States

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89bio Clinical Study Site

Canoga Park, California, United States

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89bio Clinical Study Site

Coronado, California, United States

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89bio Clinical Study Site

Fountain Valley, California, United States

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89bio Clinical Study Site

Fresno, California, United States

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89bio Clinical Study Site

Gardena, California, United States

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89bio Clinical Study Site

Huntington Park, California, United States

Site Status TERMINATED

89bio Clinical Study Site

Inglewood, California, United States

Site Status RECRUITING

89bio Clinical Study Site

Lancaster, California, United States

Site Status RECRUITING

89bio Clinical Study Site

Long Beach, California, United States

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89bio Clinical Study Site

Los Angeles, California, United States

Site Status RECRUITING

89bio Clinical Study Site

Montclair, California, United States

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89bio Clinical Study Site

Orange, California, United States

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89bio Clinical Study Site

Panorama City, California, United States

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89bio Clinical Study Site

Pasadena, California, United States

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89bio Clinical Study Site

Poway, California, United States

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89bio Clinical Study Site

Rialto, California, United States

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89bio Clinical Study Site

Santa Ana, California, United States

Site Status TERMINATED

89bio Clinical Study Site

Stanford, California, United States

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89bio Clinical Study Site

Victorville, California, United States

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89bio Clinical Study Site

Colorado Springs, Colorado, United States

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89bio Clinical Study Site

Littleton, Colorado, United States

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89bio Clinical Study Site

Brandon, Florida, United States

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89bio Clinical Study Site

Clermont, Florida, United States

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89bio Clinical Study Site

Fort Myers, Florida, United States

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89bio Clinical Study Site

Hialeah Gardens, Florida, United States

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89bio Clinical Study Site

Jacksonville, Florida, United States

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89bio Clinical Study Site

Jupiter, Florida, United States

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89bio Clinical Study Site

Lady Lake, Florida, United States

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89bio Clinical Study Site

Lady Lake, Florida, United States

Site Status TERMINATED

89bio Clinical Study Site

Lakewood Rch, Florida, United States

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89bio Clinical Study Site

Maitland, Florida, United States

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89bio Clinical Study Site

Maitland, Florida, United States

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89bio Clinical Study Site

New Port Richey, Florida, United States

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89bio Clinical Study Site

Ocala, Florida, United States

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Ocoee, Florida, United States

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Sarasota, Florida, United States

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Winter Park, Florida, United States

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89bio Clinical Study Site

Athens, Georgia, United States

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89bio Clinical Study Site

Dalton, Georgia, United States

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89bio Clinical Study Site

Hammond, Indiana, United States

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89bio Clinical Study Site

New Albany, Indiana, United States

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89bio Clinical Study Site

South Bend, Indiana, United States

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89bio Clinical Study Site

Iowa City, Iowa, United States

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89bio Clinical Study Site

Topeka, Kansas, United States

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89bio Clinical Study Site

Covington, Louisiana, United States

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89bio Clinical Study Site

Houma, Louisiana, United States

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89bio Clinical Study Site

Marrero, Louisiana, United States

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89bio Clinical Study Site

New Orleans, Louisiana, United States

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89bio Clinical Study Site

West Monroe, Louisiana, United States

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89bio Clinical Study Site

Baltimore, Maryland, United States

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89bio Clinical Study Site

Glen Burnie, Maryland, United States

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89bio Clinical Study Site

Greenbelt, Maryland, United States

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89bio Clinical Study Site

Chesterfield, Michigan, United States

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89bio Clinical Study Site

Wyoming, Michigan, United States

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89bio Clinical Study Site

Ypsilanti, Michigan, United States

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89bio Clinical Study Site

Rochester, Minnesota, United States

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89bio Clinical Study Site

Flowood, Mississippi, United States

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89bio Clinical Study Site

Las Vegas, Nevada, United States

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89bio Clinical Study Site

Florham Park, New Jersey, United States

Site Status TERMINATED

89bio Clinical Study Site

Freehold, New Jersey, United States

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89bio Clinical Study Site

Warren Township, New Jersey, United States

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89bio Clinical Study Site

Albuquerque, New Mexico, United States

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89bio Clinical Study Site

New York, New York, United States

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89bio Clinical Study Site

Charlotte, North Carolina, United States

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89bio Clinical Study Site

Durham, North Carolina, United States

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89bio Clinical Study Site

Fayetteville, North Carolina, United States

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89bio Clinical Study Site

Raleigh, North Carolina, United States

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89bio Clinical Study Site

Winston-Salem, North Carolina, United States

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89bio Clinical Study Site

Akron, Ohio, United States

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89bio Clinical Study Site

Cleveland, Ohio, United States

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89bio Clinical Study Site

Dayton, Ohio, United States

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89bio Clinical Study Site

Liberty Township, Ohio, United States

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89bio Clinical Study Site

Springboro, Ohio, United States

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89bio Clinical Study Site

Westlake, Ohio, United States

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89bio Clinical Study Site

East Greenwich, Rhode Island, United States

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89bio Clinical Study Site

Charleston, South Carolina, United States

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89bio Clinical Study Site

Columbia, South Carolina, United States

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89bio Clinical Study Site

Chattanooga, Tennessee, United States

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89bio Clinical Study Site

Cordova, Tennessee, United States

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89bio Clinical Study Site

Hermitage, Tennessee, United States

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89bio Clinical Study Site

Nashville, Tennessee, United States

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89bio Clinical Study Site

Amarillo, Texas, United States

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Austin, Texas, United States

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89bio Clinical Study Site

Austin, Texas, United States

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89bio Clinical Study Site

Austin, Texas, United States

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89bio Clinical Study Site

Bellaire, Texas, United States

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Brownsville, Texas, United States

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89bio Clinical Study Site

Corpus Christi, Texas, United States

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DeSoto, Texas, United States

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Edinburg, Texas, United States

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89bio Clinical Study Site

Farmers Branch, Texas, United States

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89bio Clinical Study Site

Fort Sam Houston, Texas, United States

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89bio Clinical Study Site

Fort Worth, Texas, United States

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89bio Clinical Study Site

Garland, Texas, United States

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89bio Clinical Study Site

Georgetown, Texas, United States

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89bio Clinical Study Site

Georgetown, Texas, United States

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89bio Clinical Study Site

Houston, Texas, United States

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