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A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Sponsor: Hoffmann-La Roche
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.
Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1350
Start Date
2024-03-13
Completion Date
2029-02
Last Updated
2026-10-23
Healthy Volunteers
No
Interventions
Pegozafermin
Subcutaneous injection
Placebo
Subcutaneous injection
Locations (370)
89bio Clinical Study Site
Birmingham, Alabama, United States
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Chandler, Arizona, United States
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Flagstaff, Arizona, United States
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Glendale, Arizona, United States
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Sun City, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Conway, Arkansas, United States
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Little Rock, Arkansas, United States
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North Little Rock, Arkansas, United States
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Canoga Park, California, United States
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Coronado, California, United States
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Escondido, California, United States
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Fountain Valley, California, United States
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Fresno, California, United States
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Gardena, California, United States
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Huntington Park, California, United States
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Inglewood, California, United States
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La Jolla, California, United States
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Lancaster, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Montclair, California, United States
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Orange, California, United States
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Panorama City, California, United States
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Pasadena, California, United States
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Poway, California, United States
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Rialto, California, United States
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Santa Ana, California, United States
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Stanford, California, United States
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Victorville, California, United States
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Colorado Springs, Colorado, United States
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Littleton, Colorado, United States
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Brandon, Florida, United States
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Clermont, Florida, United States
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Fort Myers, Florida, United States
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Hialeah Gardens, Florida, United States
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Homestead, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Lady Lake, Florida, United States
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Lady Lake, Florida, United States
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Lakewood Rch, Florida, United States
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Lehigh Acres, Florida, United States
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Maitland, Florida, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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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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Athens, Georgia, United States
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Dalton, Georgia, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Hammond, Indiana, United States
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New Albany, Indiana, United States
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South Bend, Indiana, United States
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Iowa City, Iowa, United States
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Topeka, Kansas, United States
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Louisville, Kentucky, United States
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Covington, Louisiana, United States
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Houma, Louisiana, United States
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Lake Charles, Louisiana, United States
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Marrero, Louisiana, United States
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New Orleans, Louisiana, United States
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West Monroe, Louisiana, United States
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Baltimore, Maryland, United States
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Glen Burnie, Maryland, United States
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Greenbelt, Maryland, United States
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Burlington, Massachusetts, United States
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Chesterfield, Michigan, United States
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Wyoming, Michigan, United States
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Ypsilanti, Michigan, United States
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Maplewood, Minnesota, United States
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Rochester, Minnesota, United States
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Flowood, Mississippi, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Florham Park, New Jersey, United States
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Freehold, New Jersey, United States
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Warren Township, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Carmel, New York, United States
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New York, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Fayetteville, North Carolina, United States
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Morehead City, North Carolina, United States
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Raleigh, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Dayton, Ohio, United States
89bio Clinical Study Site
Liberty Township, Ohio, United States