Status:
RECRUITING
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
Lead Sponsor:
Akero Therapeutics, Inc
Conditions:
NASH - Nonalcoholic Steatohepatitis
MASH - Metabolic Dysfunction-Associated Steatohepatitis
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 compensated cirrhosis due to NASH/MASH.
Eligibility Criteria
Inclusion
- Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
- Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
Exclusion
- Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results
- Type 1 diabetes or unstable Type 2 diabetes
- Any current or prior history of decompensated liver disease
- Other inclusion and exclusion criteria may apply
Key Trial Info
Start Date :
September 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
1150 Patients enrolled
Trial Details
Trial ID
NCT06528314
Start Date
September 4 2024
End Date
October 1 2029
Last Update
December 12 2025
Active Locations (302)
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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