Skip to main content
for people ages 18–70
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 progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis


Nonalcoholic Steatohepatitis


For people ages 18–70

Key Inclusion Criteria:

  • Liver biopsy consistent with NASH and bridging (F3 fibrosis) according to the NASH CRN classification in the opinion of the central reader
  • Has the following laboratory parameters at the screening visit:
  • 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
  • Hemoglobin A1c (HbA1c) ≤ 9.5%
  • Total bilirubin ≤ 1.5 x ULN

Key Exclusion Criteria:

  • Prior history of decompensated liver disease including ascites, hepatic encephalopathy (HE), or variceal bleeding
  • Child-Pugh (CP) score> 6, as determined at screening
  • Model for End-stage Liver Disease (MELD) score> 12, as determined at screening
  • 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 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.


  • California Pacific Medical Center accepting new patients
    San Francisco, California, 94115, United States
  • Mission Gastroenterology and Hepatology accepting new patients
    San Francisco, California, 94115, United States
  • Island View Gastroenterology Associates- Ventura accepting new patients
    Ventura, California, 93003, United States
  • Ruane Clinical Research Group accepting new patients
    Los Angeles, California, 90036, United States
  • California Liver Institute accepting new patients
    Pasadena, California, 91105, United States
  • Huntington Medical Research Institutes accepting new patients
    Pasadena, California, 91105, United States
  • Inland Empire Liver Foundation accepting new patients
    San Bernardino, California, 92377, United States
  • Southern California Liver Centers accepting new patients
    Coronado, California, 92673, United States
  • eStudySite accepting new patients
    Las Vegas, Nevada, 89109, United States
  • eStudySite accepting new patients
    Oceanside, California, 92056, United States


accepting new patients
Start Date
Completion Date
Gilead Sciences
Phase 3
Study Type
Last Updated
May 1, 2017
I'm interested in this study!