Last updated on February 2019

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment


Are you eligible to participate in this study?

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

  • Conditions: Non Alcoholic Steatohepatitis | Non Alcoholic Steatohepatitis (NASH)
  • Age: Between 18 - 85 Years
  • Gender: Male or Female

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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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