Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

Key inclusion criteria:

1. Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the
NASH CRN scoring system determined by central reading

Key exclusion criteria:

   1. Current or past history of a clinically evident hepatic decompensation event, such as
   ascites, hepatic encephalopathy (HE), or variceal bleeding

   2. Current or past history of CP score ≥7 points

   3. Model for End-stage Liver Disease (MELD) score > 12

   4. ALT ≥ 5 X ULN

   5. Calculated creatinine clearance <60mL/min using Cockcroft-Gault method

   6. Hemoglobin A1c (HbA1c) ≥ 9.5 %

   7. Evidence of other known forms of 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)

   8. History of liver transplant, or current placement on a liver transplant list