A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
Recruiting in Palo Alto (17 mi)
+24 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Akero Therapeutics, Inc
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study administered for 16 weeks in subjects with biopsy proven F1 - F4 NASH.
Research Team
Eligibility Criteria
Inclusion Criteria
Ballooning degeneration (scored 0 to 2),
Main Study only: Must have confirmation of ≥ 10% liver fat content on magnetic resonance imaging- proton density fat fraction (MRI-PDFF) at screening.
Steatosis (scored 0 to 3)
See 5 more
Treatment Details
Interventions
- Efruxifermin (Recombinant Protein)
Participant Groups
6Treatment groups
Experimental Treatment
Placebo Group
Group I: EFX Dose 3Experimental Treatment1 Intervention
Main Study
Group II: EFX Dose 2Experimental Treatment1 Intervention
Main Study
Group III: EFX Dose 1Experimental Treatment1 Intervention
Main Study
Group IV: EFX Dose (Cohort C)Experimental Treatment1 Intervention
Group V: PlaceboPlacebo Group1 Intervention
Main Study
Group VI: Placebo (Cohort C)Placebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Akero Clinical Study SiteKansas City, MO
Akero Clinical Study SiteDallas, TX
Akero Clinical Study SiteSan Antonio, TX
Akero Clinical Study SiteWebster, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Akero Therapeutics, Inc
Lead Sponsor
Trials
6
Patients Recruited
3,900+