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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03400163
Other study ID # MB130-045 A
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 8, 2015
Est. completion date June 19, 2017

Study information

Verified date February 2021
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date June 19, 2017
Est. primary completion date January 18, 2017
Accepts healthy volunteers No
Gender All
Age group 21 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BMS-986036
BMS-986036 20 mg QD
Placebo
Placebo QD

Locations

Country Name City State
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Texas Liver Institute San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From Day 1 to Day 112
Primary Number of Participants With Adverse Events (AEs) The number of participants with on-study AEs was reported for each arm. From first dose to date of last dose plus 30 days
Primary Number of Participants With Serious Adverse Events (SAEs) The number of participants with on-study SAEs was reported for each arm. From first dose to date of last dose plus 30 days
Primary Number of Participants With Injection Site Reactions The number of participants with on-study injection site reactions was reported for each arm. From first dose to date of last dose plus 30 days
Primary 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. From first dose to date of last dose plus 30 days
Primary Number of Deaths The number of deaths was reported for each arm. From first dose to date of last dose plus 30 days
Primary 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. From first dose to date of last dose plus 30 days
Primary 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. From first dose to date of last dose plus 30 days
Primary 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. From first dose to date of last dose plus 30 days
Primary 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. From first dose to date of last dose plus 30 days
Primary 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. From Day 1 to Day 112
Secondary 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. From Day 1 to Day 112
Secondary 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. From Day 1 to Day 142
Secondary 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. From Day 1 to Day 142
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