Status:
ACTIVE_NOT_RECRUITING
A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Lead Sponsor:
Akero Therapeutics, Inc
Conditions:
NASH/MASH
NAFLD/MASLD
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.
Eligibility Criteria
Inclusion
- Main Study Only:
- Males and non-pregnant, non-lactating females between 18 - 80 (between 19-80 in the Republic of Korea) years of age inclusive, on the day of signing informed consent
- 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
- Suspected or confirmed diagnosis of NASH/MASH or NAFLD/MASLD or non-invasively diagnosed NASH/MASH or NAFLD/MASLD
- Open-Label Rollover
- Prior participation in a previous Akero Phase 2 study
Exclusion
- Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results, including but not limited to: alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis \[PBC\], primary sclerosing cholangitis \[PSC\], autoimmune hepatitis), drug induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency
- Type 1 or unstable Type 2 diabetes
- A reduced list of inclusion and exclusion criteria apply to participants in the open-label rollover extension.
- Other inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT06161571
Start Date
November 10 2023
End Date
October 1 2026
Last Update
September 12 2025
Active Locations (211)
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1
Akero Clinical Study Site
Birmingham, Alabama, United States, 35209
2
Akero Clinical Study Site
Chandler, Arizona, United States, 85224
3
Akero Clinical Study Site
Flagstaff, Arizona, United States, 86001
4
Akero Clinical Study Site
Peoria, Arizona, United States, 85381