Status:
COMPLETED
A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
Lead Sponsor:
Akero Therapeutics, Inc
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in non-cirrhotic subjects with biopsy-proven F2 - F3 NASH.
Eligibility Criteria
Inclusion
- Males and non-pregnant, non-lactating females between 18 - 75 years of age inclusive, based on the date of the screening visit.
- 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
- Weight loss \> 5% in the 3 months prior to screening until randomization or from the time of the diagnostic liver biopsy until randomization, whichever is longer.
- Presence of cirrhosis on liver biopsy (stage 4 fibrosis).
- Type 1 or uncontrolled Type 2 diabetes.
- Other inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
February 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2024
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04767529
Start Date
February 16 2021
End Date
May 2 2024
Last Update
June 18 2025
Active Locations (55)
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1
Akero Clinical Study Site
Chandler, Arizona, United States, 85224
2
Akero Clinical Study Site
Glendale, Arizona, United States, 85304
3
Akero Clinical Study Site
Tucson, Arizona, United States, 85712
4
Akero Clinical Study Site
North Little Rock, Arkansas, United States, 72117