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
Overview
- Phase
- Phase 2
- Intervention
- BMS-986036
- Conditions
- Non-Alcoholic Steatohepatitis
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 184
- Locations
- 17
- Primary Endpoint
- Number of Participants With Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Treatment Group B: BMS-986036
Administered as specified on specified days
Intervention: BMS-986036
Treatment Group C: Placebo
Administered as specified on specified days
Intervention: Placebo
Treatment Group A: BMS-986036
Administered as specified on specified days
Intervention: BMS-986036
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcomes
- Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112(From Day 1 to Day 112)
- Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142(From Day 1 to Day 142)
- Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142(From Day 1 to Day 142)