for people ages 18–70 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:



The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)


Nonalcoholic Steatohepatitis Fatty Liver Non-alcoholic Fatty Liver Disease


For people ages 18–70

Key Inclusion Criteria:

  • Liver biopsy consistent with NASH and cirrhosis (F4 fibrosis) according to the NASH Clinical Research Network (CRN) classification, in the opinion of the central reader
  • Has the following laboratory parameters at the screening visit, as determined by the central laboratory:
  • Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)
  • Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
  • HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is unable to be resulted)

Key Exclusion Criteria:

  • Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
  • Child-Pugh (CP) score > 7, as determined at screening, unless due to therapeutic anti-coagulation
  • Model for End-stage Liver Disease (MELD) score > 12, as determined at screening,unless due to therapeutic anti-coagulation
  • Other causes of liver disease including, but not limited to, alcoholic liver disease,hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history and/or centralized review of liver histology.
  • History of liver transplantation
  • Current or history of hepatocellular carcinoma (HCC)

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


  • University of California, San Francisco-Liver Clinic
    San Francisco, California, 94143, United States
  • California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant
    San Francisco, California, 94115, United States
  • eStudySite
    San Francisco, California, 94115, United States
  • Fresno Clinical Research Center
    Fresno, California, 93720, United States
  • University of California, Davis Medical Center
    Sacramento, California, 95817, United States
  • Island View Gastroenterology Associates- Ventura
    Ventura, California, 93003, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California, 90048, United States
  • Veterans Affair Greater Los Angeles Healthcare System, West Los Angeles VA Medical Center
    Los Angeles, California, 90073, United States
  • Ruane Clinical Research Group
    Los Angeles, California, 90036, United States
  • California Liver Research Institute
    Pasadena, California, 91105, United States
  • Huntington Medical Research Institutes (HMRI) Liver Center
    Pasadena, California, 91105, United States
  • Inland Empire Liver Foundation
    Rialto, California, 92377, United States
  • Kaiser Permanente
    San Diego, California, 92514, United States


in progress, not accepting new patients
Start Date
Completion Date
Gilead Sciences
Phase 3
Study Type
Last Updated
February 23, 2018