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



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal, Gastrointestinal, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 75
Updated:1/23/2019
Start Date:May 4, 2018
End Date:April 5, 2021
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Email:Clinical.Trials@bms.com
Phone:please email:

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A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in Adults With Nonalcoholic Steatohepatitis (NASH) and Compensated Liver Cirrhosis

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).


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Liver biopsy performed within 6 months prior to the Screening Visit; if not performed
within 6 months prior to the Screening Visit, a liver biopsy will be performed during
the Screening Period and at least 4 weeks prior to randomization (biopsy must be
consistent with NASH and cirrhosis 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 dosing regimens for at least 3 months prior to the Screening Visit

- Participants taking vitamin E at doses ≥800 IU/day must have been on stable doses for
at least 6 months prior to the Screening Visit (Vitamin E treatment must not have been
initiated after the 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, autoimmune hepatitis, drug-induced
hepatotoxicity, Wilson disease, alpha-1-antitrypsin deficiency, iron overload, and
hemochromatosis)

- 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
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San Clemente, California 92673
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3300 Gallows Road
Falls Church, Virginia 22042
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