A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
- Registration Number
- NCT02413372
- Lead Sponsor
- Bristol-Myers Squibb
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
- Male or female between 21 and 75 years old
- Body Mass Index (BMI) of 25 or more
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group C: Placebo Placebo Administered as specified on specified days Treatment Group A: BMS-986036 BMS-986036 Administered as specified on specified days Treatment Group B: BMS-986036 BMS-986036 Administered as specified on specified days
- Primary Outcome Measures
Name Time Method Number of Participants With Serious Adverse Events (SAEs) 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 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 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 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) From Day 1 to Day 112 The mean percent change in bone mineral density from baseline to day 112 reported for each arm.
Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 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) 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 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 Injection Site Reactions 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.
Number of Participants With Vital Sign Abnormalities 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 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 Outcome Measures
Name Time Method Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112 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.
Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142 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.
Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142 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.
Trial Locations
- Locations (17)
Quality Medical Research PLLC
🇺🇸Nashville, Tennessee, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Indiana University Health - University Hospital
🇺🇸Indianapolis, Indiana, United States
University Of California, San Diego
🇺🇸San Diego, California, United States
Carolinas Healthcare System
🇺🇸Charlotte, North Carolina, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Upmc Center For Liver Diseases
🇺🇸Pittsburgh, Pennsylvania, United States
Unc Hospitals And Clinics
🇺🇸Chapel Hill, North Carolina, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Texas Clinical Research Institute, LLC
🇺🇸Arlington, Texas, United States
St. Luke'S Episcopal Hospital - Baylor College Of Medicine
🇺🇸Houston, Texas, United States
Texas Liver Institute
🇺🇸San Antonio, Texas, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States