A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic
 Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by
 alcohol) and liver cirrhosis (liver damage characterized by normal liver tissue being
 replaced by scar tissue).
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
 visit www.BMSStudyConnect.com

 Inclusion Criteria:

 -  Liver biopsy performed within 6 months (26 weeks) prior to the screening period. If
 historical biopsy is not available, a liver biopsy will be performed during the
 screening period. Biopsy must be consistent with NASH and cirrhosis according to the
 NASH CRN classification, as assessed by the central reader

 -  Participants taking anti-diabetic, anti-obesity, or anti-dyslipidemic medications must
 have been on stable regimens for at least 3 months (12 weeks) (6 weeks for statins)
 prior to and during the screening period

 -  Participants taking vitamin E at doses greater than or equal to (>=) 800 IU/day must
 have been on stable doses for at least 6 months (26 weeks) prior to and during the
 screening period. Vitamin E treatment (>=800 IU/day) must not have been initiated
 after the qualifying liver biopsy was performed

 Exclusion Criteria:

 -  Other causes of liver disease (e.g., alcoholic liver disease, hepatitis B virus
 infection, chronic hepatitis C virus infection [HCV], autoimmune hepatitis,
 drug-induced hepatotoxicity, Wilson disease, α-1-antitrypsin deficiency, iron
 overload, and hemochromatosis); participants with HCV sustained viral response
 (undetectable HCV RNA) for at least 2 years prior to biopsy confirming study
 eligibility may be eligible

 -  Current or past history of hepatocellular carcinoma (HCC)

 -  Past or current evidence of hepatic decompensation (e.g., ascites, variceal bleeding,
 hepatic encephalopathy and/or spontaneous bacterial peritonitis) or liver
 transplantation

 -  Medical history of gastroesophageal varices, except if esophagogastroduodenoscopy
 [EGD] performed within 12 months prior to the Screening Period has shown <= Grade 1
 varices

 Other protocol defined inclusion/exclusion criteria could apply