Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

• Status: Completed
• Trial end date: 2019-11-19
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are:

• To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and cilofexor (CILO), administered alone or in combination, in participants with bridging fibrosis or compensated cirrhosis due to NASH

• To evaluate changes in liver fibrosis, without worsening of NASH

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

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Firsocostat

Criteria

Key Inclusion Criteria:

• Liver biopsy consistent with NASH and F3 or F4 in the opinion of the central reader

• In participants who have never had a liver biopsy, liver stiffness by FibroScan® ≥ 14.0 kPa and Enhanced Liver Fibrosis (ELF™) Test score ≥ 9.8 at Screening

• Screening laboratory parameters, as determined by the central laboratory:

• Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation

• Hemoglobin A1c (HbA1c) ≤ 9.5%

• Alanine aminotransferase (ALT) < 5 x Upper Limits of Normal (ULN)

• Platelet count ≥ 125,000/μL

Key Exclusion Criteria:

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

• Child-Pugh (CP) score > 6 at Screening, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation

• Model for End-Stage Liver Disease (MELD) score > 12 at Screening, unless due to an alternate etiology such as therapeutic anticoagulation

• Other causes of liver disease based on medical history and/or centralized review of liver histology, including but not limited to: alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment

• History of liver transplantation

• Current or prior history of hepatocellular carcinoma

Note: Other protocol defined Inclusion/ Exclusion criteria may apply