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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

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)

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 : 3 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 Sub-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 D:
Administered as specified on specified days
Drug: BMS-986036
BMS-986036 20 mg QD

Placebo Comparator: Treatment Group E:
Administered as specified on specified days
Drug: Placebo
Placebo QD




Primary Outcome Measures :
  1. Change in percent hepatic fat fraction (%) by Magnetic Resonance Imaging (MRI) [ Time Frame: From Day 1 to Day 112 ]
  2. 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) ]
  3. Number of participants with marked laboratory abnormalities [ Time Frame: From first dose to date of last dose plus 100 days (up to 212 days) ]
  4. 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) ]
  5. 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) ]
  6. Number of participants with injection site reactions [ Time Frame: From first dose to date of last dose plus 100 days (up to 212 days) ]
  7. Mean percent change from baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) [ Time Frame: From Day 1 to Day 112 ]

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 ]
  2. Percentage of participants with positive Anti-BMS-986036 Antibody response at Day 142 [ Time Frame: From Day 1 to Day 142 ]
  3. Percentage of participants with positive Anti-FGF21 Antibody response at Day 142 [ Time Frame: From Day 1 to Day 142 ]


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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): NCT03400163


Locations
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United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Texas Liver Institute
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03400163     History of Changes
Other Study ID Numbers: MB130-045 A
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

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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