A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis

Completed · Phase 2 · Has a placebo group

Conditions studied: 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 stage 3 liver fibrosis (severe fibrosis).

Key facts

Study ID

NCT03486899

Run by

Bristol-Myers Squibb

People needed

197

Starts

2018-06-19

Expected to finish

2021-08-17

Last updated by the study team

2022-09-09

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, 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.

You may not qualify if…

• 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

Where it is running

• Local Institution - 0005 — Chandler, Arizona, United States
• Local Institution - 0088 — Phoenix, Arizona, United States
• Local Institution - 0001 — Phoenix, Arizona, United States
• The Institute for Liver Health - Tucson — Tucson, Arizona, United States
• Kindred Medical Institute for Clinical Trials — Corona, California, United States
• Local Institution - 0092 — Coronado, California, United States
• University of California San Diego — 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
• Local Institution - 0008 — Oakland, California, United States
• Local Institution - 0044 — Oxnard, California, United States
• Huntington Medical Research Institutes - HMRI Liver Center — Pasadena, California, United States
• Local Institution - 0019 — Pasadena, California, United States
• Local Institution - 0074 — Redwood City, California, United States
• Local Institution - 0013 — Rialto, California, United States
• Local Institution - 0089 — San Clemente, California, United States
• Medical Associates Research Group — San Diego, California, United States
• Local Institution - 0068 — San Francisco, California, United States
• Bridgeport Hospital — Bridgeport, Connecticut, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Local Institution - 0079 — Coral Gables, Florida, United States
• Top Medical Research — Cutler Bay, Florida, United States
• Local Institution - 0087 — Madison, Alabama, United States

Full record on ClinicalTrials.gov

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