A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
Condition: Hepatic Cirrhosis; Liver Fibrosis; Nonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Liver Cirrhosis; Fatty Liver; Non-alcoholic Fatty Liver Disease; Fibrosis
Intervention: BMS-986036; Placebo
Intervention description: Specified dose on specified days.; Specified dose on specified days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        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

          -  Must be 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 apply