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

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ClinicalTrials.gov Identifier: NCT03400163
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE January 2, 2018
First Posted Date  ICMJE January 17, 2018
Last Update Posted Date January 19, 2018
Actual Study Start Date  ICMJE May 8, 2015
Actual Primary Completion Date January 18, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
  • Change in percent hepatic fat fraction (%) by Magnetic Resonance Imaging (MRI) [ Time Frame: From Day 1 to Day 112 ]
  • Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation [ Time Frame: From first dose to date of last dose plus 100 days (up to 212 days) ]
  • Number of participants with marked laboratory abnormalities [ Time Frame: From first dose to date of last dose plus 100 days (up to 212 days) ]
  • Number of participants with clinically relevant ECG abnormalities [ Time Frame: From first dose to date of last dose plus 100 days (up to 212 days) ]
  • Number of participants with clinically relevant vital sign abnormalities [ Time Frame: From first dose to date of last dose plus 100 days (up to 212 days) ]
  • Number of participants with injection site reactions [ Time Frame: From first dose to date of last dose plus 100 days (up to 212 days) ]
  • Mean percent change from baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) [ Time Frame: From Day 1 to Day 112 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03400163 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
  • Geometric mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112 [ Time Frame: From Day 1 to Day 112 ]
  • Percentage of participants with positive Anti-BMS-986036 Antibody response at Day 142 [ Time Frame: From Day 1 to Day 142 ]
  • Percentage of participants with positive Anti-FGF21 Antibody response at Day 142 [ Time Frame: From Day 1 to Day 142 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Sub-study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Sub-study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-986036 in Adults With Non-alcoholic Steatohepatitis
Brief Summary The purpose of this sub-study of MB130-045 is to determine the pharmacokinetic effects, pharmacodynamic effects, efficacy and safety of BMS-986036 20 mg QD in subjects with Non-alcoholic Steatohepatitis (NASH)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Non-Alcoholic Steatohepatitis
Intervention  ICMJE
  • Drug: BMS-986036
    BMS-986036 20 mg QD
  • Drug: Placebo
    Placebo QD
Study Arms  ICMJE
  • Experimental: Treatment Group D:
    Administered as specified on specified days
    Intervention: Drug: BMS-986036
  • Placebo Comparator: Treatment Group E:
    Administered as specified on specified days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2018)
3
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 19, 2017
Actual Primary Completion Date January 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03400163
Other Study ID Numbers  ICMJE MB130-045 A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP