Last updated on July 2017

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Gastrointestinal Diseases and Disorders
  • Age: Between 18 - 70 Years
  • Gender: Male or Female

Inclusion Criteria

  1. Willing and able to give informed consent prior to any study specific procedures being performed
  2. Liver biopsy consistent with NASH (defined as the presence of at least grade 1 steatosis, hepatocellular ballooning, and lobular inflammation according to the NAFLD Activity Score [NAS]) and bridging (F3 fibrosis) according to the NASH CRN classification, in the opinion of the central reader.
    1. A historical liver biopsy within 6 months of the Screening visit may be accepted as the Screening biopsy if the sample is deemed acceptable for interpretation by the central reader.
    2. If the subject is deemed ineligible for this study, the liver biopsy, if performed according to protocol specifications and is within 12 months of the Screening visit, may be used to determine eligibility for study GS-US-384-1944.
  3. Subject has the following laboratory parameters at the Screening visit, as determined by the central laboratory:
    1. ALT ≤ 8 x ULN
    2. CLcr = 30 mL/min, as calculated by the Cockcroft-Gault equation
    3. HbA1c ≤ 9.5%
    4. Total bilirubin ≤ 1.5 x ULN
  4. Body Mass Index (BMI) = 18 kg/m2 at Screening
  5. Males and non-pregnant, non-lactating females between 18-70 years of age; inclusive based on the date of the Screening visit
  6. Females of childbearing potential must have a negative pregnancy test at Screening and Day 1
  7. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception.
Exclusion Criteria
  1. Prior history of decompensated liver disease, including ascites, HE, or variceal bleeding
  2. CP score > 6, as determined at Screening
  3. MELD score > 12, as determined at Screening
  4. Chronic HBV infection (HBsAg positive)
  5. Chronic HCV infection (HCV Ab and HCV RNA positive). Subjects cured of HCV infection less than 5 years prior to the Screening visit are not eligible.
  6. Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing cholangitis, and autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history and centralized review of liver histology.
  7. History of liver transplantation
  8. Current or history of HCC
  9. Any weight reduction surgery in the 2 years prior to Screening or planned during the study (weight reduction surgery is disallowed during the study), and malabsorptive weight loss surgery (e.g., Roux-en-Y or distal gastric bypass) at any time prior to Screening
  10. Weight loss > 10% within 6 months of Screening
  11. HIV infection (HIV Ab and HIV ribonucleic acid [HIV RNA] positive)
  12. Current alcohol consumption greater than 21 oz/week for males or 14 oz/week for females (1oz/30mL of alcohol is present in 1 12oz/360mL beer, 1 4oz/120mL glass of wine, and a 1 oz/30 mL measure of 40 proof alcohol)
  13. Positive urine drug screen for amphetamines, cocaine or opiates (i.e. heroin, morphine) at Screening. Subjects on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening may be included in the study. Subjects with a positive urine drug screen due to prescription opioid-based medication are eligible if the prescription and diagnosis are reviewed and approved by the investigator
  14. Unstable cardiovascular disease as defined by any of the following:
    1. Unstable angina, myocardial infarction, coronary artery bypass graft surgery or coronary angioplasty within 6 months prior to Screening
    2. Transient ischemic attack or cerebrovascular accident within 6 months prior to Screening
    3. Symptomatic obstructive valvular heart disease or hypertrophic cardiomyopathy
    4. Congestive heart failure
  15. Use of any prohibited concomitant medication. Subjects on Vitamin E must be on a stable dose for at least 6 months prior to Day 1 and subjects on thiazolidinediones (TZDs) must be on a stable dose for at least 3 months prior to Day 1
  16. History of a malignancy within 5 years of Screening with the following exceptions:
    1. Adequately treated carcinoma in situ of the cervix
    2. Adequately treated basal or squamous cell cancer or other localized non-melanoma skin cancer
  17. Unable to safely undergo a liver biopsy
  18. Participation in another investigational study of a drug or device within 30 days or within 5 half-lives of the prior investigational agent (whichever is longer) prior to Screening
  19. Concurrent participation in another therapeutic clinical study
  20. Known hypersensitivity to SEL, the metabolites, or formulation excipient
  21. Any laboratory abnormality or condition that, in the investigator’s opinion, could adversely affect the safety of the subject or impair the assessment of study results
  22. Presence of any condition that could, in the opinion of the investigator, compromise the subject’s ability to participate in the study, including a history of substance abuse or a psychiatric condition requiring hospitalization or emergency room visit within 2 years of Screening
  23. Unavailable for follow-up assessment or concern for subject’s compliance with the protocol procedures.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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