Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
Trial Parameters
Brief Summary
Subjects with biopsy-proven NASH will be randomly assigned in a 2:1 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks. Subjects will be evaluated regularly for safety, and efficacy biomarkers will be measured at Baseline and Weeks 6, 12, 24, and 36. At Week 36, all subjects will undergo liver biopsy.
Eligibility Criteria
Inclusion Criteria: 1. At least 18 years of age. 2. AST at Screening of ≥20 IU/L. 3. FibroScan LSM ≥8.5 kPa 4. Diagnosis of NASH by biopsy at Screening showing NAS ≥4 by central read, with a score of at least 1 point in each of the 3 histologic categories of steatosis, inflammation, and hepatocellular ballooning (Kleiner 2005). If the subject has had a qualifying liver biopsy within 6 months prior to Baseline and the slides are available for central read prior to randomization, this biopsy can be waived. 5. Concomitant biopsy-proven Stage 1-3 hepatic fibrosis by NASH CRN criteria by central read (Kleiner 2005). 6. At least 2 of the following criteria for the metabolic syndrome: * Obesity, defined waist circumference \>88 cm for women or \>102 cm for men * Hypertriglyceridemia, defined as \>150 mg/dL (\>1.7 mmol/L) or on drug treatment for hypertriglyceridemia * Reduced high-density lipoprotein (HDL) cholesterol, defined as \<40 mg/dL (\<1.03 mmol/L) in men or \<50 mg/dL (\<1.3 mmol/L)