Overview

A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis

Status:
Active, not recruiting
Trial end date:
2021-10-27
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Criteria
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

- 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