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

Primary Purpose

Non-Alcoholic Steatohepatitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BMS-986036
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Steatohepatitis focused on measuring First Line Therapy, NASH

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson University Hospital
  • Texas Liver Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group D:

Treatment Group E:

Arm Description

Administered as specified on specified days

Administered as specified on specified days

Outcomes

Primary Outcome Measures

Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16
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.
Number of Participants With Adverse Events (AEs)
The number of participants with on-study AEs was reported for each arm.
Number of Participants With Serious Adverse Events (SAEs)
The number of participants with on-study SAEs was reported for each arm.
Number of Participants With Injection Site Reactions
The number of participants with on-study injection site reactions was reported for each arm.
Number of Participants With Adverse Events Leading to Discontinuation
The number of participants with on-study AEs leading to discontinuation was reported for each arm.
Number of Deaths
The number of deaths was reported for each arm.
Number of Participants With Marked Laboratory Abnormalities
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.
Number of Participants With Vital Sign Abnormalities
The number of participants with out-of-range vital signs noted during interim or final vital sign assessments was reported for each arm.
Number of Participants With Electrocardiogram (ECG) Abnormalities
The number of participants with out-of-range ECG intervals observed during interim or final electrocardiogram assessments was reported for each arm.
Number of Participants With Physical Examination Abnormalities
The number of participants with abnormalities observed during interim or final physical examination assessments is reported for each arm.
Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA)
The mean percent change in bone mineral density from baseline to day 112 reported for each arm.

Secondary Outcome Measures

Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at 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.
Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at 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.
Number of Participants With Positive Anti-FGF21 Antibody Response at 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.

Full Information

First Posted
January 2, 2018
Last Updated
February 24, 2021
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03400163
Brief Title
A Sub-study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 8, 2015 (Actual)
Primary Completion Date
January 18, 2017 (Actual)
Study Completion Date
June 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Steatohepatitis
Keywords
First Line Therapy, NASH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group D:
Arm Type
Experimental
Arm Description
Administered as specified on specified days
Arm Title
Treatment Group E:
Arm Type
Placebo Comparator
Arm Description
Administered as specified on specified days
Intervention Type
Drug
Intervention Name(s)
BMS-986036
Intervention Description
BMS-986036 20 mg QD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo QD
Primary Outcome Measure Information:
Title
Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16
Description
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.
Time Frame
From Day 1 to Day 112
Title
Number of Participants With Adverse Events (AEs)
Description
The number of participants with on-study AEs was reported for each arm.
Time Frame
From first dose to date of last dose plus 30 days
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
The number of participants with on-study SAEs was reported for each arm.
Time Frame
From first dose to date of last dose plus 30 days
Title
Number of Participants With Injection Site Reactions
Description
The number of participants with on-study injection site reactions was reported for each arm.
Time Frame
From first dose to date of last dose plus 30 days
Title
Number of Participants With Adverse Events Leading to Discontinuation
Description
The number of participants with on-study AEs leading to discontinuation was reported for each arm.
Time Frame
From first dose to date of last dose plus 30 days
Title
Number of Deaths
Description
The number of deaths was reported for each arm.
Time Frame
From first dose to date of last dose plus 30 days
Title
Number of Participants With Marked Laboratory Abnormalities
Description
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.
Time Frame
From first dose to date of last dose plus 30 days
Title
Number of Participants With Vital Sign Abnormalities
Description
The number of participants with out-of-range vital signs noted during interim or final vital sign assessments was reported for each arm.
Time Frame
From first dose to date of last dose plus 30 days
Title
Number of Participants With Electrocardiogram (ECG) Abnormalities
Description
The number of participants with out-of-range ECG intervals observed during interim or final electrocardiogram assessments was reported for each arm.
Time Frame
From first dose to date of last dose plus 30 days
Title
Number of Participants With Physical Examination Abnormalities
Description
The number of participants with abnormalities observed during interim or final physical examination assessments is reported for each arm.
Time Frame
From first dose to date of last dose plus 30 days
Title
Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA)
Description
The mean percent change in bone mineral density from baseline to day 112 reported for each arm.
Time Frame
From Day 1 to Day 112
Secondary Outcome Measure Information:
Title
Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112
Description
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.
Time Frame
From Day 1 to Day 112
Title
Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142
Description
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.
Time Frame
From Day 1 to Day 142
Title
Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142
Description
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.
Time Frame
From Day 1 to Day 142

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States

12. IPD Sharing Statement

Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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