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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis

In brief

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).

Key facts

Study ID

NCT03486912

Run by

Bristol-Myers Squibb

People needed

155

Starts

2018-06-12

Expected to finish

2021-09-14

Last updated by the study team

2022-10-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0005 — Chandler, Arizona, United States
• Local Institution - 0088 — Phoenix, Arizona, United States
• Local Institution - 0006 — Phoenix, Arizona, United States
• Local Institution - 0090 — Tucson, Arizona, United States
• Kindred Medical Institute for Clinical Trials — Corona, California, United States
• Local Institution - 0092 — Coronado, California, United States
• Local Institution - 0038 — La Jolla, California, United States
• Local Institution - 0017 — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• GastroIntestinal Biosciences — Los Angeles, California, United States
• Catalina Research Institute — Montclair, California, United States
• Kaiser Permanente — Oakland, California, United States
• Diverse Research Solutions — Oxnard, California, United States
• Huntington Medical Research Institutes - HMRI Liver Center — Pasadena, California, United States
• Local Institution - 0020 — Pasadena, California, United States
• Local Institution - 0073 — Redwood City, California, United States
• Local Institution - 0012 — Rialto, California, United States
• Local Institution - 0089 — San Clemente, California, United States
• Local Institution — San Diego, California, United States
• Local Institution - 0014 — San Diego, California, United States
• Local Institution - 0068 — San Francisco, California, United States
• Local Institution - 0042 — Bridgeport, Connecticut, United States
• Local Institution — Washington D.C., District of Columbia, United States
• Local Institution - 0079 — Coral Gables, Florida, United States
• North Alabama Health Research, LLC — Madison, Alabama, United States

Full record on ClinicalTrials.gov

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