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A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02413372
Recruitment Status : Completed
First Posted : April 9, 2015
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine whether BMS-986036 is effective in the treatment of subjects with Non-alcoholic Steatohepatitis (NASH).

Condition or disease Intervention/treatment Phase
Non-Alcoholic Steatohepatitis Drug: BMS-986036 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-986036 in Adults With Non-alcoholic Steatohepatitis
Actual Study Start Date : May 8, 2015
Actual Primary Completion Date : January 18, 2017
Actual Study Completion Date : June 19, 2017


Arm Intervention/treatment
Experimental: Treatment Group A: BMS-986036
Administered as specified on specified days
Drug: BMS-986036
Experimental: Treatment Group B: BMS-986036
Administered as specified on specified days
Drug: BMS-986036
Placebo Comparator: Treatment Group C: Placebo
Administered as specified on specified days
Drug: Placebo



Primary Outcome Measures :
  1. Change in percent hepatic fat fraction (%) by Magnetic Resonance Imaging (MRI) [ Time Frame: From screening/baseline to week 16 ]
  2. Safety, as measured by adverse events (AEs) [ Time Frame: From screening/baseline, subsequent days after, upto week 16 ]
  3. Safety, as measured by clinical laboratory tests [ Time Frame: From screening/baseline, subsequent days after, upto week 16 ]
  4. Safety, as measured by vital signs [ Time Frame: From screening/baseline, subsequent days after, upto week 16 ]
  5. Safety, as measured by electrocardiograms [ Time Frame: From screening/baseline, subsequent days after, upto week 16 ]
  6. Safety, as measured by physical examinations [ Time Frame: From screening/baseline, subsequent days after, upto week 16 ]
  7. Safety, as measured by bone mineral density [ Time Frame: From screening/baseline, subsequent days after, upto week 16 ]

Secondary Outcome Measures :
  1. BMS-986036 observed concentration by Ctrough [ Time Frame: From Day 1 to Day 142 ]
  2. Anti-BMS-986036 antibodies [ Time Frame: From Day 1 to Day 142 ]
  3. Anti-FGF21 antibodies [ Time Frame: From Day 1 to Day 142 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Male or female between 21 and 75 years old
  • Body Mass Index (BMI) of 25 or more

Exclusion Criteria:

  • Chronic Liver disease other than NASH
  • Uncontrolled diabetes
  • Any major surgery within 6 weeks of screening
  • Unable to self-administer under the skin injections
  • Any bone trauma, fracture or bone surgery within 8 weeks of screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413372


Locations
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United States, California
Inland Empire Liver Foundation
Rialto, California, United States, 92377
University Of California, San Diego
San Diego, California, United States, 92103
United States, Indiana
Indiana University Health - University Hospital
Indianapolis, Indiana, United States, 46202
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63104
United States, North Carolina
Unc Hospitals And Clinics
Chapel Hill, North Carolina, United States, 27599-7584
Carolinas Healthcare System
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Upmc Center For Liver Diseases
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Gastro One
Germantown, Tennessee, United States, 38138
Quality Medical Research PLLC
Nashville, Tennessee, United States, 37211
United States, Texas
Texas Clinical Research Institute, LLC
Arlington, Texas, United States, 76012
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
St. Luke'S Episcopal Hospital - Baylor College Of Medicine
Houston, Texas, United States, 77030
Texas Liver Institute
San Antonio, Texas, United States, 78215
United States, Virginia
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0341
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02413372     History of Changes
Other Study ID Numbers: MB130-045
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
First Line Therapy
NASH
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases