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

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