Status:
RECRUITING
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Lead Sponsor:
Akero Therapeutics, Inc
Conditions:
NASH With Fibrosis
MASH With Fibrosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 stud...
Eligibility Criteria
Inclusion
- Males and non-pregnant, non-lactating females between 18 - 80 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.
- Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 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
- Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results.
- Presence of cirrhosis on liver biopsy (fibrosis stage 4).
- Type 1 or uncontrolled Type 2 diabetes.
- Other inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2032
Estimated Enrollment :
1650 Patients enrolled
Trial Details
Trial ID
NCT06215716
Start Date
December 1 2023
End Date
November 1 2032
Last Update
December 16 2025
Active Locations (338)
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1
Akero Clinical Study Site
Birmingham, Alabama, United States, 35209
2
Akero Clinical Study Site
Dothan, Alabama, United States, 36301
3
Akero Clinical Study Site
Chandler, Arizona, United States, 85224
4
Akero Clinical Study Site
Flagstaff, Arizona, United States, 86001