|Research Studies » Non-Alcoholic Steatohepatitis (NASH)|
A Phase 2b Randomized, Double Blind, Placebo-Controlled, Multicenter Study Evaluating Safety and Efficacy of EDP-305 in Subjects with Liver-Biopsy Proven Non-Alcoholic Steatohepatitis (NASH)
1. Male and female subjects, of all ethnic origins, between the ages of 18 and 75 years, inclusive.
2. Subjects of all ethnic origins should have a Body Mass Index (BMI) > 25 kg/m2 and ≤45 except for Asian subjects who qualify for the study with BMI > 23kg/m2.
3. Histological evidence of definite NASH based on NASH Clinical Research Network (CRN) criteria obtained from assessment of a liver biopsy by the central histopathologist. The biopsy may be obtained either 1) during the Screening window or 2) within 6 months prior to the Screening visit.
4. NAFLD Activity Score (NAS) of 4 or greater with a score of at least 1 in each component of the NAS (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2).
5. Fibrosis stage 2 or 3 using the NASH CRN Histologic Scoring System