A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
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.
| Condition(s) | NASH - Nonalcoholic Steatohepatitis, MASH - Metabolic Dysfunction-Associated Steatohepatitis |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH and NAS score of \>=3 (at least 1 in each category) or evidence of steatosis and 2 current features of metabolic comorbidities * Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH Exclusion Criteria: * 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. |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Akero Therapeutics, Inc |
| Locations | Birmingham, Alabama, United States; Dothan, Alabama, United States; Chandler, Arizona, United States; Flagstaff, Arizona, United States; Peoria, Arizona, United States; Scottsdale, Arizona, United States (+316 more sites) |
| Start date | 2024-09-04 |
| NCT ID | NCT06528314 |
| Official listing | https://clinicaltrials.gov/study/NCT06528314 |