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



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:September 27, 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 Stage 3 Liver Fibrosis

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).


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, 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 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
We found this trial at
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Saint Louis, Missouri 63104
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
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Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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1200 Moursund Street
Houston, Texas 77030
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1 Tampa General Cir
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500 S State St
Ann Arbor, Michigan 48109
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Arlington, Texas 76012
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345 Saint Paul Place
Baltimore, Maryland 21202
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2388 Mcfaddin Avenue
Beaumont, Texas 77702
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600 S Dobson Road
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Charlotte, North Carolina 28204
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1801 Inwood Rd
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100 North Academy Avenue
Danville, Pennsylvania 17822
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4401 Wornall Rd
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Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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Lakewood Ranch, Florida 34211
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
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70 Washington Square S
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111 S 11th St
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