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A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Sponsor: Akero Therapeutics, Inc
Summary
The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
700
Start Date
2023-11-10
Completion Date
2026-06-19
Last Updated
2026-04-30
Healthy Volunteers
No
Conditions
Interventions
Efruxifermin
Administered by subcutaneous (SC) injection
Placebo
Administered by SC injection
Locations (211)
Akero Clinical Study Site
Birmingham, Alabama, United States
Akero Clinical Study Site
Chandler, Arizona, United States
Akero Clinical Study Site
Flagstaff, Arizona, United States
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Peoria, 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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Jonesboro, 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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Chula Vista, California, United States
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Coronado, California, United States
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Cypress, California, United States
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Inglewood, California, United States
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La Mesa, California, United States
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Lancaster, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Palm Springs, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Santa Maria, California, United States
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Englewood, Colorado, United States
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Bradenton, Florida, United States
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Brandon, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Hialeah Gardens, Florida, United States
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Inverness, Florida, United States
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Jacksonville, 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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Largo, Florida, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Naples, Florida, United States
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Ocala, Florida, United States
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Port Orange, Florida, United States
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Sarasota, Florida, United States
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The Villages, Florida, United States
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Venice, Florida, United States
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Viera, Florida, United States
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West Palm Beach, Florida, United States
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Winter Park, Florida, United States
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Winter Park, Florida, United States
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Columbus, Georgia, United States
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Gainesville, Georgia, United States
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Marietta, Georgia, United States
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South Bend, Indiana, United States
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West Des Moines, Iowa, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Bastrop, Louisiana, United States
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Covington, Louisiana, United States
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Houma, Louisiana, United States
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Marrero, Louisiana, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, 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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South Dartmouth, Massachusetts, United States
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Southfield, Michigan, United States
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Wyoming, Michigan, United States
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Ypsilanti, Michigan, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Brick, New Jersey, United States
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Florham Park, New Jersey, United States
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Somers Point, New Jersey, United States
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Sparta, New Jersey, United States
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Santa Fe, New Mexico, United States
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New York, New York, United States
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New York, New York, United States
Akero Clinical Study Site
Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Fayetteville, North Carolina, United States
Akero Clinical Study Site
Morehead City, North Carolina, United States
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New Bern, North Carolina, United States
Akero Clinical Study Site
Raleigh, North Carolina, United States
Akero Clinical Study Site
Statesville, North Carolina, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Springboro, Ohio, United States
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Westlake, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Columbia, South Carolina, United States
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Summerville, South Carolina, United States
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Chattanooga, Tennessee, United States
Akero Clinical Study Site
Clarksville, Tennessee, United States
Akero Clinical Study Site
Hermitage, Tennessee, United States
Akero Clinical Study Site
Nashville, Tennessee, United States