for people ages 18-80 (full criteria)
at La Jolla, California and other locations
study started
estimated completion



The primary objectives of this study are: - To assess the safety and tolerability of selonsertib (SEL), GS-0976, and GS-9674, administered alone or in combination, in participants with bridging fibrosis or compensated cirrhosis due to Nonalcoholic Steatohepatitis (NASH) - To evaluate changes in liver fibrosis, without worsening of NASH

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects With Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)


Nonalcoholic SteatohepatitisFatty LiverNon-alcoholic Fatty Liver DiseaseSELGS-0976GS-9674


For people ages 18-80

Key Inclusion Criteria:

  • Liver biopsy consistent with NASH and bridging fibrosis (F3) and cirrhosis (F4) in the opinion of the central reader
  • In participants who have never had a liver biopsy, liver stiffness by FibroScan® and Enhanced Liver Fibrosis (ELF™) Test score 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
  • 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


  • UCSD NAFLD Clinical Research Center
    La JollaCalifornia92037United States
  • Medical Associates Research Group
    San DiegoCalifornia92123United States


in progress, not accepting new patients
Start Date
Completion Date
Gilead Sciences
Phase 2
Study Type
Last Updated