Clinical Research Details Clinical Research A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis Study Description This study aims to find out how safe and effective the investigational drug (also called a study drug) "obeticholic acid" (also known as OCA) may be in improving compensated cirrhosis caused by Nonalcoholic Steatohepatitis (NASH). This study has two parts: Part 1 is called the Double-Blind phase because neither the participant nor the doctor will know if the participant is receiving the study drug (OCA) or placebo (dummy pill). Part 2 is called the Open-Label Extension phase because all participants will receive the study drug (OCA), and no one will receive a placebo. This study is currently closed to enrollment. Inclusion/Exclusion 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: Current or past history of a clinically evident hepatic decompensation event, such as ascites, hepatic encephalopathy (HE), or variceal bleeding Current or past history of CP score ≥7 points Model for End-stage Liver Disease (MELD) score > 12 ALT ≥ 5 X ULN Calculated creatinine clearance <60mL/min using Cockcroft-Gault method Hemoglobin A1c (HbA1c) ≥ 9.5 % 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) History of liver transplant, or current placement on a liver transplant list Investigators Neha Agrawal, M.B.B.S. (M.D.) Medicine Maged P. Ghali, M.D. Medicine