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 hepatic decompensation such as clinically significant
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 ≥ 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