The purpose of this study is to determine whether BMS-986036 is effective in the treatment of subjects with Non-alcoholic Steatohepatitis (NASH).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
184
Inland Empire Liver Foundation
Rialto, California, United States
University Of California, San Diego
San Diego, California, United States
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.
Time frame: From Day 1 to Day 112
Number of Participants With Adverse Events (AEs)
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
Number of Participants With Serious Adverse Events (SAEs)
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
Number of Participants With Injection Site Reactions
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
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.
Time frame: From first dose to date of last dose plus 30 days
Number of Deaths
The number of deaths was reported for each arm.
Time frame: From first dose to date of last dose plus 30 days
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.
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Indiana University Health - University Hospital
Indianapolis, Indiana, United States
Saint Louis University
St Louis, Missouri, United States
Unc Hospitals And Clinics
Chapel Hill, North Carolina, United States
Carolinas Healthcare System
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Upmc Center For Liver Diseases
Pittsburgh, Pennsylvania, United States
Gastro One
Germantown, Tennessee, United States
...and 7 more locations
Time frame: From first dose to date of last dose plus 30 days
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.
Time frame: From first dose to date of last dose plus 30 days
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.
Time frame: From first dose to date of last dose plus 30 days
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.
Time frame: From first dose to date of last dose plus 30 days
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.
Time frame: From Day 1 to Day 112
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.
Time frame: From Day 1 to Day 112
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.
Time frame: From Day 1 to Day 142
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.
Time frame: From Day 1 to Day 142