A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
NCT ID: NCT02413372
Last Updated: 2021-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
184 participants
INTERVENTIONAL
2015-05-08
2017-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment Group A: BMS-986036
Administered as specified on specified days
BMS-986036
Treatment Group B: BMS-986036
Administered as specified on specified days
BMS-986036
Treatment Group C: Placebo
Administered as specified on specified days
Placebo
Interventions
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BMS-986036
BMS-986036
Placebo
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of 25 or more
Exclusion Criteria
* 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
21 Years
75 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Inland Empire Liver Foundation
Rialto, California, United States
University Of California, San Diego
San Diego, California, United States
Indiana University Health - University Hospital
Indianapolis, Indiana, United States
Saint Louis University
St Louis, Missouri, United States
Unc Hospitals And Clinics
Chapel Hill, North Carolina, United States
Carolinas Healthcare System
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Upmc Center For Liver Diseases
Pittsburgh, Pennsylvania, United States
Gastro One
Germantown, Tennessee, United States
Quality Medical Research PLLC
Nashville, Tennessee, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
St. Luke'S Episcopal Hospital - Baylor College Of Medicine
Houston, Texas, United States
Texas Liver Institute
San Antonio, Texas, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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Sanyal A, Charles ED, Neuschwander-Tetri BA, Loomba R, Harrison SA, Abdelmalek MF, Lawitz EJ, Halegoua-DeMarzio D, Kundu S, Noviello S, Luo Y, Christian R. Pegbelfermin (BMS-986036), a PEGylated fibroblast growth factor 21 analogue, in patients with non-alcoholic steatohepatitis: a randomised, double-blind, placebo-controlled, phase 2a trial. Lancet. 2019 Dec 22;392(10165):2705-2717. doi: 10.1016/S0140-6736(18)31785-9. Epub 2018 Dec 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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MB130-045
Identifier Type: -
Identifier Source: org_study_id
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