IRB Study Number 25-1117
Status Recruiting
Phase Phase 3
Location Cleveland Clinic Weston Hospital
Institute Digestive Disease & Surgery Institute
Description
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.
Inclusion Criteria
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 Criteria
- 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.
