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

February 24, 2021 updated by: Bristol-Myers Squibb

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

The purpose of this study is to determine whether BMS-986036 is effective in the treatment of subjects with Non-alcoholic Steatohepatitis (NASH).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Rialto, California, United States, 92377
        • Inland Empire Liver Foundation
      • San Diego, California, United States, 92103
        • University of California, San Diego
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health - University Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7584
        • Unc Hospitals And Clinics
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Healthcare System
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Center for Liver Diseases
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research PLLC
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute, LLC
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • Houston, Texas, United States, 77030
        • St. Luke'S Episcopal Hospital - Baylor College Of Medicine
      • San Antonio, Texas, United States, 78215
        • Texas Liver Institute
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
      • Richmond, Virginia, United States, 23298-0341
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group A: BMS-986036
Administered as specified on specified days
Drug: BMS-986036
Experimental: Treatment Group B: BMS-986036
Administered as specified on specified days
Drug: BMS-986036
Placebo Comparator: Treatment Group C: Placebo
Administered as specified on specified days
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Day 1 to Day 112
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.
From first dose to date of last dose plus 30 days
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.
From first dose to date of last dose plus 30 days
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.
From first dose to date of last dose plus 30 days
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.
From first dose to date of last dose plus 30 days
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.
From first dose to date of last dose plus 30 days
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.
From first dose to date of last dose plus 30 days
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.
From first dose to date of last dose plus 30 days
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.
From first dose to date of last dose plus 30 days
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.
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)
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.
From Day 1 to Day 112

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Day 1 to Day 112
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.
From Day 1 to Day 142
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.
From Day 1 to Day 142

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2015

Primary Completion (Actual)

January 18, 2017

Study Completion (Actual)

June 19, 2017

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 9, 2015

Study Record Updates

Last Update Posted (Actual)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB130-045

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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