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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
Results First Posted : January 28, 2020
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 [ Time Frame: From Day 1 to Day 112 ]
    The mean change in percent hepatic fat fraction (%) by MRI from baseline to Week 16 was assessed for each arm. A longitudinal repeated measures analysis was used to analyze the change in hepatic fat fraction (%) at Week 16 from baseline in the treated population who have both a baseline and at least one post-baseline measurement.

  2. Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose to date of last dose plus 30 days ]
    The number of participants with on-study AEs was reported for each arm.

  3. Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: From first dose to date of last dose plus 30 days ]
    The number of participants with on-study SAEs was reported for each arm.

  4. Number of Participants With Injection Site Reactions [ Time Frame: From first dose to date of last dose plus 30 days ]
    The number of participants with on-study injection site reactions was reported for each arm.

  5. Number of Participants With Adverse Events Leading to Discontinuation [ Time Frame: From first dose to date of last dose plus 30 days ]
    The number of participants with on-study AEs leading to discontinuation was reported for each arm.

  6. Number of Deaths [ Time Frame: From first dose to date of last dose plus 30 days ]
    The number of deaths was reported for each arm.

  7. Number of Participants With Marked Laboratory Abnormalities [ Time Frame: From first dose to date of last dose plus 30 days ]
    The number of participants whose worst toxicity grade increased from baseline to grade 3 or 4 (Toxicity Scale: DAIDS Version 1.0) is reported for each arm.

  8. Number of Participants With Vital Sign Abnormalities [ Time Frame: From first dose to date of last dose plus 30 days ]
    The number of participants with out-of-range vital signs noted during interim or final vital sign assessments was reported for each arm.

  9. Number of Participants With Electrocardiogram (ECG) Abnormalities [ Time Frame: From first dose to date of last dose plus 30 days ]
    The number of participants with out-of-range ECG intervals observed during interim or final electrocardiogram assessments was reported for each arm.

  10. Number of Participants With Physical Examination Abnormalities [ Time Frame: From first dose to date of last dose plus 30 days ]
    The number of participants with abnormalities observed during interim or final physical examination assessments is reported for each arm.

  11. Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) [ Time Frame: From Day 1 to Day 112 ]
    The mean percent change in bone mineral density from baseline to day 112 reported for each arm.


Secondary Outcome Measures :
  1. Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112 [ Time Frame: From Day 1 to Day 112 ]
    The observed serum concentration of BMS-986036 before the next dose is administered (pre-dose concentration) was assessed for both C-terminal intact and total molecule. Geometric means are presented for each arm.

  2. Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142 [ Time Frame: From Day 1 to Day 142 ]
    Participants were monitored for antibodies to study medication using a validated ADA homogenous bridge assay with BMS-986036 and electrochemical luminescence detection. The number of treated participants with positive Anti-BMS-986036 antibody titers up to Day 142 with regards to baseline was reported for each arm.

  3. Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142 [ Time Frame: From Day 1 to Day 142 ]
    Participants were monitored for antibodies to FGF21 using a validated homogenous bridge assay with Met-FGF21 (recombinant produced) and electrochemical luminescence detection. The number of treated participants with positive Anti-FGF21 antibody titers up to Day 142 with regards to baseline was reported for each arm.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Contacts and Locations
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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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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] June 3, 2016
Statistical Analysis Plan  [PDF] September 18, 2017

More Information
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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    
Other Study ID Numbers: MB130-045
First Posted: April 9, 2015    Key Record Dates
Results First Posted: January 28, 2020
Last Update Posted: February 26, 2021
Last Verified: February 2021

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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