A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis
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 stage 3 liver fibrosis (severe fibrosis).
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, with: a) a score of at least 1
 for each NAS component (steatosis, lobular inflammation, and ballooning), as assessed
 by the central reader, and b) stage 3 liver fibrosis 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 [HCV] infection, 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

 Other protocol defined inclusion/exclusion criteria could apply