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
We found this trial at
82
sites
Norfolk, Virginia 23502
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Norfolk, VA
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Phone: 703-776-3592
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
2314
mi
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Falls Church, VA
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Phone: 832-355-8966
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
1890
mi
from 98109
Houston, TX
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Phone: 646-888-1395
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
2527
mi
from 98109
Tampa, FL
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Albuquerque, New Mexico 87108
1187
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from 98109
Albuquerque, NM
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-647-0236
University of Michigan The University of Michigan was founded in 1817 as one of the...
1903
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Ann Arbor, MI
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Arlington, Texas 76012
Phone: 817-471-1070
1670
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Arlington, TX
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345 Saint Paul Place
Baltimore, Maryland 21202
Phone: 410-843-2075
2328
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Baltimore, MD
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2388 Mcfaddin Avenue
Beaumont, Texas 77702
1924
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Beaumont, TX
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Boston, Massachusetts 02111
2485
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Boston, MA
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Bridgeport, Connecticut 06610
Phone: 203-384-4849
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Bridgeport, CT
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Buffalo, New York 14215
2112
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Buffalo, NY
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Burlington, Vermont
2326
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Burlington, VT
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Catonsville, Maryland 21228
Phone: 410-737-0053
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Catonsville, MD
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600 S Dobson Road
Chandler, Arizona 85224
1130
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Chandler, AZ
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Charlotte, North Carolina 28204
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Charlotte, NC
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Charlottesville, Virginia 22908
2285
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Charlottesville, VA
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Coral Gables, Florida 33134
Phone: 615-591-0211
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Coral Gables, FL
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Coronado, California 92118
1067
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Coronado, CA
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Phone: 214-645-6188
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
1682
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from 98109
Dallas, TX
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Dallas, Texas 75203
Phone: 214-947-1288
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Dallas, TX
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3409 Worth Street
Dallas, Texas 75231
Phone: 146993031244514
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Dallas, TX
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5425 West Spring Creek Parkway
Dallas, Texas 75234
Phone: 469-317-7703
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Dallas, TX
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100 North Academy Avenue
Danville, Pennsylvania 17822
2273
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Danville, PA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-684-9019
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
2341
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Durham, NC
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Fall River, Massachusetts 02721
Phone: 508-672-7450
2399
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Fall River, MA
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Fort Worth, Texas 76104
Phone: 817-922-9968
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Fort Worth, TX
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Gainesville, Virginia 20155
Phone: 571-748-4714
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Gainesville, VA
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Germantown, Tennessee 38138
Phone: 901-682-2450
1877
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Germantown, TN
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Hermitage, Tennessee 37076
Phone: 425-260-1131
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Hermitage, TN
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2387 West 68th Street
Hialeah, Florida 33016
2720
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Hialeah, FL
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Homestead, Florida 33030
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Homestead, FL
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Houston, Texas 77030
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Houston, TX
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Humble, Texas 77338
Phone: 281-888-5564
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Humble, TX
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Jacksonville, Florida 32216
Phone: 904-953-8503
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Jacksonville, FL
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Phone: 816-932-3623
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
1504
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from 98109
Kansas City, MO
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Kansas City, Missouri 64108
1503
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Kansas City, MO
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Lakewood Ranch, Florida 34211
Phone: 941-727-7772
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Lakewood Ranch, FL
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Long Beach, California 90822
Phone: 951-220-4029
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Long Beach, CA
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Los Angeles, California 90067
Phone: 323-954-8084
959
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Los Angeles, CA
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Los Angeles, California 90095
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Los Angeles, CA
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5901 West Olympic Boulevard
Los Angeles, California 90036
Phone: 13239540400249
960
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Los Angeles, CA
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Madison, Alabama 35758
Phone: 256-960-9445
2032
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Madison, AL
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Manhasset, New York 11030
Phone: 516-562-2082
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Manhasset, NY
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Miami, Florida 33136
Phone: 305-243-4648
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Miami, FL
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Miami, Florida 33136
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Miami, FL
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Miami, Florida 33157
Phone: 17864467220116
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Miami, FL
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Montclair, California 91763
Phone: 909-445-8458
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Montclair, CA
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Nashville, Tennessee 37203
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Nashville, TN
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Phone: 504-988-5763
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
2099
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New Orleans, LA
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New Orleans, Louisiana 70118
2097
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New Orleans, LA
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70 Washington Square S
New York, New York 10012
(212) 998-1212
Phone: 646-501-4926
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
2402
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from 98109
New York, NY
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Phone: 212-241-0493
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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New York, NY
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Newark, New Jersey 07102
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Newark, NJ
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Oakland, California 94612
Phone: 323-783-8977
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Oakland, CA
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100 West Gore Street
Orlando, Florida 32806
Phone: 407-426-9299
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Orlando, FL
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Oxnard, California 93030
Phone: 805-483-1185
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Oxnard, CA
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Pasadena, California 91105
Phone: 626-795-5769
957
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Pasadena, CA
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734 Fairmount Avenue
Pasadena, California 91105
Phone: 626-397-5820
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Pasadena, CA
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-7979
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Philadelphia, PA
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Phoenix, Arizona 85016
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Phoenix, Arizona 85054
Phone: 480-342-2536
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Pittsburgh, Pennsylvania 15240
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Portland, Oregon 97201
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Portland, OR
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Redwood City, California 94063
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1939 Roland Clarke Place
Reston, Virginia 20191
Phone: 571-281-1736
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Rialto, California 92377
Phone: 909-883-2999
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Richland, Washington 99352
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Richland, WA
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Richmond, Virginia 23219
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Saint Louis, Missouri 63110
Phone: 314-977-9388
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Saint Louis, Missouri 63104
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San Antonio, Texas 78215
Phone: 210-253-3426
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San Antonio, TX
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San Antonio, Texas 78229
Phone: 2106141234451
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San Clemente, California 92673
Phone: 404-881-1094
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San Diego, California 92123
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San Diego, California 92105
Phone: 619-563-4040
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San Diego, CA
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
Phone: 415-600-6525
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
680
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San Francisco, CA
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Toronto, Ontario
Phone: 12124204670
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Toronto,
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Tucson, Arizona 86711
Phone: 480-686-8874
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Washington, District of Columbia 20007
Phone: 202-444-1879
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Wilmington, North Carolina 28401
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Wilmington, NC
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Winston-Salem, North Carolina
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Winston-Salem, NC
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