Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)

• Status: Completed
• Trial end date: 2020-12-17
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the safety and tolerability of selonsertib, firsocostat, cilofexor, fenofibrate and/or Vascepa® in adults with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Eicosapentaenoic acid ethyl ester; Fenofibrate; Firsocostat

Criteria

Key Inclusion Criteria:

• Males and females between 18-75 years of age (Cohorts 1-9: 18-75 years and Cohorts 10-13: ≥ 18 years); inclusive based on the date of the screening visit

• Willing and able to provide informed consent prior to any study specific procedures being performed

• Meets the following conditions (Cohorts 1-6 and 9):

• Clinical diagnosis of non-alcoholic fatty liver disease and evidence of F2-3 fibrosis

• For Cohorts 7 and 8, participants must have a clinical diagnosis of NAFLD and cirrhosis

• For Cohorts 10 and 11, individuals must have a clinical diagnosis of NAFLD and meet one of the following criteria :

• a) A historical liver biopsy within 6 months of Screening consistent with NASH and bridging fibrosis (F3) or within 12 months of Screening consistent with NASH and compensated cirrhosis (F4) in the opinion of the investigator,

• b) Screening liver stiffness by MRE ≥ 3.64 kPa;

• c) Screening liver stiffness by FibroScan® ≥ 9.9 kPa;

• For Cohorts 12 and 13, subjects must have a clinical diagnosis of NAFLD/NASH and one of the following criteria:

• a) At least two criteria for metabolic syndrome

• b) Historical liver biopsy consistent with NASH within 6-12 months of Screening

• c) Historical MRE with liver stiffness ≥ 2.88 kPa within 6 months of Screening

• d) Historical FibroScan® with liver stiffness ≥ 9.9 kPa within 6 months of Screening,

Key Exclusion Criteria:

• Pregnant or lactating females

• Other causes of liver disease including autoimmune, viral, and alcoholic liver disease

• Any history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding

• For Cohorts 7-8, 10-13, Child-Pugh-Turcotte (CPT) score > 6

• History of liver transplantation

Note: Other protocol defined Inclusion/Exclusion criteria may apply.