A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
NCT ID: NCT04767529
Last Updated: 2025-06-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
128 participants
INTERVENTIONAL
2021-02-16
2024-05-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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placebo
double-blind, once-weekly subcutaneous injection
Placebo
subcutaneous injection
Efruxifermin 28 mg
double-blind, once-weekly subcutaneous injection
Efruxifermin
subcutaneous injection
Efruxifermin 50 mg
double-blind, once-weekly subcutaneous injection
Efruxifermin
subcutaneous injection
Interventions
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Efruxifermin
subcutaneous injection
Placebo
subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.
* FibroScan measurement \> 8.5 kPa \[kilopascal\].
* Biopsy-proven NASH. Must have had a liver biopsy obtained ≤ 180 days prior to randomization with fibrosis stage 2 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
* Steatosis (scored 0 to 3),
* Ballooning degeneration (scored 0 to 2), and
* Lobular inflammation (scored 0 to 3).
Exclusion Criteria
* Presence of cirrhosis on liver biopsy (stage 4 fibrosis).
* Type 1 or uncontrolled Type 2 diabetes.
18 Years
75 Years
ALL
No
Sponsors
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Akero Therapeutics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Akero Study Director
Role: STUDY_DIRECTOR
Study Director
Locations
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Akero Clinical Study Site
Chandler, Arizona, United States
Akero Clinical Study Site
Glendale, Arizona, United States
Akero Clinical Study Site
Tucson, Arizona, United States
Akero Clinical Study Site
North Little Rock, Arkansas, United States
Akero Clinical Study Site
Chula Vista, California, United States
Akero Clinical Study Site
Fresno, California, United States
Akero Clinical Study Site
La Jolla, California, United States
Akero Clinical Study Site
Los Angeles, California, United States
Akero Clinical Study Site
Los Angeles, California, United States
Akero Clinical Study Site
Los Angeles, California, United States
Akero Clinical Study Site
Orange, California, United States
Akero Clinical Study Site
Panorama City, California, United States
Akero Clinical Study Site
Rialto, California, United States
Akero Clinical Study Site
Santa Ana, California, United States
Akero Clinical Study Site
Fort Myers, Florida, United States
Akero Clinical Study Site
Inverness, Florida, United States
Akero Clinical Study Site
Lakewood Rch, Florida, United States
Akero Clinical Study Site
Miami, Florida, United States
Akero Clinical Study Site
Miami, Florida, United States
Akero Clinical Study Site
Miami Lakes, Florida, United States
Akero Clinical Study Site
Ocala, Florida, United States
Akero Clinical Study Site
Sarasota, Florida, United States
Akero Clinical Study Site
Marietta, Georgia, United States
Akero Clinical Study Site
Topeka, Kansas, United States
Akero Clinical Study Site
Baton Rouge, Louisiana, United States
Akero Clinical Study Site
Marrero, Louisiana, United States
Akero Clinical Study Site
Ypsilanti, Michigan, United States
Akero Clinical Study Site
Flowood, Mississippi, United States
Akero Clinical Study Site
Jackson, Mississippi, United States
Akero Clinical Study Site
Las Vegas, Nevada, United States
Akero Clinical Study Site
Charlotte, North Carolina, United States
Akero Clinical Study Site
Durham, North Carolina, United States
Akero Clinical Study Site
Morehead City, North Carolina, United States
Akero Clinical Study Site
Cincinnati, Ohio, United States
Akero Clinical Study Site
Greenville, South Carolina, United States
Akero Clinical Study Site
Hermitage, Tennessee, United States
Akero Clinical Study Site
Nashville, Tennessee, United States
Akero Clinical Study Site
Arlington, Texas, United States
Akero Clinical Study Site
Austin, Texas, United States
Akero Clinical Study Site
Cedar Park, Texas, United States
Akero Clinical Study Site
Dallas, Texas, United States
Akero Clinical Study Site
Dallas, Texas, United States
Akero Clinical Study Site
Edinburg, Texas, United States
Akero Clinical Study Site
Fort Worth, Texas, United States
Akero Clinical Study Site
Garland, Texas, United States
Akero Clinical Study Site
Houston, Texas, United States
Akero Clinical Study Site
San Antonio, Texas, United States
Akero Clinical Study Site
San Antonio, Texas, United States
Akero Clinical Study Site
San Antonio, Texas, United States
Akero Clinical Study Site
San Marcos, Texas, United States
Akero Clinical Study Site
Webster, Texas, United States
Akero Clinical Study Site
Charlottesville, Virginia, United States
Akero Clinical Study Site
Richmond, Virginia, United States
Akero Clinical Study Site
Richmond, Virginia, United States
Akero Clinical Study Site
San Juan, , Puerto Rico
Countries
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References
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Harrison SA, Frias JP, Neff G, Abrams GA, Lucas KJ, Sanchez W, Gogia S, Sheikh MY, Behling C, Bedossa P, Shao L, Chan D, Fong E, de Temple B, Shringarpure R, Tillman EJ, Rolph T, Cheng A, Yale K; HARMONY Study Group. Safety and efficacy of once-weekly efruxifermin versus placebo in non-alcoholic steatohepatitis (HARMONY): a multicentre, randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Gastroenterol Hepatol. 2023 Dec;8(12):1080-1093. doi: 10.1016/S2468-1253(23)00272-8. Epub 2023 Oct 3.
Noureddin M, Frias JP, Neff GW, Lucas KJ, Behling C, Bedossa P, Dubourg J, Chan D, Burch M, Fong E, de Temple B, Minerva M, Barrett K, Shringarpure R, Tillman EJ, Rolph T, Cheng A, Yale K. Safety and efficacy of once-weekly efruxifermin versus placebo in metabolic dysfunction-associated steatohepatitis (HARMONY): 96-week results from a multicentre, randomised, double-blind, placebo-controlled, phase 2b trial. Lancet. 2025 Aug 16;406(10504):719-730. doi: 10.1016/S0140-6736(25)01073-6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AK-US-001-0102
Identifier Type: -
Identifier Source: org_study_id
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