AKERO AK-US-001-0106 (AKERO 106) is a study that will be running in parallel with AKERO 105. This Phase 3 trial targets patients with compensated cirrhosis (F4 fibrosis) due to metabolic dysfunction-associated steatohepatitis (MASH). It will evaluate the efficacy of efruxifermin in improving liver function and reducing disease progression in cirrhotic patients who currently have limited treatment options.
To participate in this trial, all individuals must meet the following criteria:
- Age 18 - 80 years
- Have biopsy-proven compensated cirrhosis due to NASH/MASH (Fibrosis Stage 4)*
- Have no varices on centrally read esophagogastroduodenoscopy (EGD)*
- Have current or prior evidence of liver steatosis via liver biopsy, MRI-PDFF, FibroScan© CAP, and/or ultrasound
- Currently diagnosed with type 2 diabetes (T2D) or have 2 of 4 signs of metabolic syndrome (obesity, dyslipidemia, high blood pressure, high fasting glucose)
- BMI ≥ 25.0 kg/m2
- Have a stable alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels
- No history of decomposition or other liver diseases, HCC, and diabetes mellitus type 1 (DM1)
*For Cohort 1, participants will need to meet all of the previous criteria to participate. For Cohort 2, participants can have low-risk varices on EGD and a FibroScan© LSM ≥ 20.0 kPa OR ELF score ≥ 10.5 at screening if a biopsy is not available.
To learn more please email: kianakhbari@arizona.edu