A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis (Protocol 747-303)

Trial ID:
IRB-15-6686
Paul Pockros
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Inclusion Criteria:

  • 1. Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by presence of all 3 key histological features of NASH according to NASH CRN criteria.
  • 2. Histologic evidence of fibrosis stage 2 or stage 3 as defined by the NASH CRN scoring of fibrosis, or
    • Histologic evidence of fibrosis stage 1a or stage 1b if accompanied by ≥1 of the following risk factors:

      • Obesity (BMI ≥30 kg/m2)
      • Type 2 diabetes diagnosed per 2013 American Diabetes Association criteria
      • ALT >1.5× upper limit of normal (ULN).
    • 3. For subjects with a historical biopsy, is either not taking or is on stable doses of TZDs/glitazones or vitamin E for 6 months before Day 1.
    • 4. Stable body weight.

    Exclusion Criteria:

    • 1. Model for End-stage Liver Disease (MELD) score >12
    • 2. ALT ≥10× ULN
    • 3. HbA1c >9.5%
    • 4. Total bilirubin >1.5 mg/dL
    • 5. Evidence of other known forms of known chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC)
    • 6. History of liver transplant, or current placement on a liver transplant list
    • 7. Current or history of significant alcohol consumption
    • 8. Prior or planned ileal resection, or prior or planned bariatric surgery
    • 9. Histological presence of cirrhosis
  • 10. History of biliary diversion
  • 11. Known positivity for human immunodeficiency virus infection.
  • 12. Acute cholecystitis or acute biliary obstruction.
  • 13. BMI >45 kg/m2

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