A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
NCT ID: NCT03976401
Last Updated: 2022-08-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2019-05-28
2022-01-10
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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EFX Dose 1
Main Study
EFX
Administered by subcutaneous injection
EFX Dose 2
Main Study
EFX
Administered by subcutaneous injection
EFX Dose 3
Main Study
EFX
Administered by subcutaneous injection
Placebo
Main Study
Placebo
Administered by subcutaneous injection
EFX Dose (Cohort C)
EFX
Administered by subcutaneous injection
Placebo (Cohort C)
Placebo
Administered by subcutaneous injection
Interventions
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EFX
Administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* Main Study only: Body mass index (BMI) \> 25 kg/m\^2 (unless the patient has biopsy-proven NASH documented within the last 2 years).
* Main Study only: Must have confirmation of ≥ 10% liver fat content on magnetic resonance imaging- proton density fat fraction (MRI-PDFF) at screening.
* Main Study only: Biopsy-proven NASH. Must have had a liver biopsy within 180 days of randomization with fibrosis stage 1 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)
* Cohort C only: FibroScan® measurement \> 13.1 kPa.
* Cohort C only: Cirrhosis due to NASH. Liver biopsy consistent with F4 fibrosis according to the NAS system, confirmed by the central or local reader.
Exclusion Criteria
* Type 1 and insulin-dependent Type 2 diabetes.
* Poorly controlled hypertension (blood pressure \> 160/100).
18 Years
80 Years
ALL
No
Sponsors
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Akero Therapeutics, Inc
INDUSTRY
Responsible Party
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Locations
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Akero Clinical Study Site
Tucson, Arizona, United States
Akero Clinical Study Site
Little Rock, Arkansas, United States
Akero Clinical Study Site
Huntington Park, 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
Panorama City, California, United States
Akero Clinical Study Site
Poway, California, United States
Akero Clinical Study Site
Boca Raton, Florida, United States
Akero Clinical Study Site
Lakewood Rch, Florida, United States
Akero Clinical Study Site
Miami, Florida, United States
Akero Clinical Study Site
New Port Richey, Florida, United States
Akero Clinical Study Site
Ocoee, Florida, United States
Akero Clinical Study Site
Port Orange, Florida, United States
Akero Clinical Study Site
Sarasota, Florida, United States
Akero Clinical Study Site
Baton Rouge, Louisiana, United States
Akero Clinical Study Site
Marrero, Louisiana, United States
Akero Clinical Study Site
Kansas City, Missouri, United States
Akero Clinical Study Site
Berlin, New Jersey, United States
Akero Clinical Study Site
Chattanooga, Tennessee, United States
Akero Clinical Study Site
Cedar Park, 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
San Antonio, Texas, United States
Akero Clinical Study Site
San Antonio, Texas, United States
Akero Clinical Study Site
Webster, Texas, United States
Akero Clinical Study Site
San Juan, , Puerto Rico
Countries
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References
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Alkhouri N, Beyer C, Shumbayawonda E, Andersson A, Yale K, Rolph T, Chung RT, Vuppalanchi R, Cusi K, Loomba R, Pansini M, Dennis A. Decreases in cT1 and liver fat content reflect treatment-induced histological improvements in MASH. J Hepatol. 2025 Mar;82(3):438-445. doi: 10.1016/j.jhep.2024.08.031. Epub 2024 Sep 25.
Harrison SA, Ruane PJ, Freilich B, Neff G, Patil R, Behling C, Hu C, Shringarpure R, de Temple B, Fong E, Tillman EJ, Rolph T, Cheng A, Yale K. A randomized, double-blind, placebo-controlled phase IIa trial of efruxifermin for patients with compensated NASH cirrhosis. JHEP Rep. 2022 Aug 23;5(1):100563. doi: 10.1016/j.jhepr.2022.100563. eCollection 2023 Jan.
Harrison SA, Ruane PJ, Freilich BL, Neff G, Patil R, Behling CA, Hu C, Fong E, de Temple B, Tillman EJ, Rolph TP, Cheng A, Yale K. Efruxifermin in non-alcoholic steatohepatitis: a randomized, double-blind, placebo-controlled, phase 2a trial. Nat Med. 2021 Jul;27(7):1262-1271. doi: 10.1038/s41591-021-01425-3. Epub 2021 Jul 8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Main Study
Document Type: Statistical Analysis Plan: Cohort C
Other Identifiers
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AK-US-001-0101
Identifier Type: -
Identifier Source: org_study_id
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