NCT06215716 A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
| NCT ID | NCT06215716 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Akero Therapeutics, Inc |
| Condition | NASH With Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,650 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2032-11 |
Trial Parameters
Eligibility Fast-Check
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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 study will enroll subjects in two cohorts for a total samples size of 1650 subjects.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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