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A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Sponsor: Akero Therapeutics, Inc
Summary
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1650
Start Date
2023-12-01
Completion Date
2033-02
Last Updated
2026-10-15
Healthy Volunteers
No
Conditions
Interventions
Efruxifermin
Administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
Locations (359)
Akero Clinical Study Site
Birmingham, Alabama, United States
Akero Clinical Study Site
Dothan, Alabama, United States
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Chandler, Arizona, United States
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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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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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Escondido, California, United States
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Folsom, 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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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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Los Angeles, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Orange, California, United States
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Palm Springs, California, United States
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Pasadena, California, United States
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Redwood City, California, United States
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Sacramento, 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 Diego, California, United States
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San Francisco, 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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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Englewood, Colorado, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Washington D.C., District of Columbia, United States
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Bradenton, Florida, United States
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Brandon, Florida, United States
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Doral, 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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Lehigh Acres, Florida, United States
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Maitland, Florida, United States
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Margate, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Gardens, Florida, United States
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Miami Lakes, Florida, United States
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Naples, 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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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Port Orange, Florida, United States
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Riverview, Florida, United States
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Sarasota, Florida, United States
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Temple Terrace, 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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Weston, 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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Zephyrhills, Florida, United States
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Atlanta, Georgia, 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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Chicago, Illinois, United States
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Hammond, Indiana, United States
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Indianapolis, Indiana, 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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Louisville, Kentucky, United States
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Bastrop, Louisiana, United States
Akero Clinical Study Site
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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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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West Monroe, Louisiana, United States
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Baltimore, Maryland, United States
Akero Clinical Study Site
Glen Burnie, Maryland, United States