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

Overview

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)

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 18, 2017

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Treatment Group D:
    • Administered as specified on specified days
  • Placebo Comparator: Treatment Group E:
    • Administered as specified on specified days

Clinical Trial Outcome Measures

Primary Measures

  • 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 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 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.
  • 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.
  • 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 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.
  • 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.
  • 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.

Secondary Measures

  • Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112
    • Time Frame: 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-BMS-986036 Antibody (ADA) Response at Day 142
    • Time Frame: 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.
  • Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb

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