A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
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
1 other identifier
interventional
184
1 country
17
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2015
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2015
CompletedFirst Posted
Study publicly available on registry
April 9, 2015
CompletedStudy Start
First participant enrolled
May 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2017
CompletedResults Posted
Study results publicly available
January 28, 2020
CompletedFebruary 26, 2021
February 1, 2021
1.7 years
April 7, 2015
January 16, 2020
February 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
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
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
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
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
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
Number of Deaths
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
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
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
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
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)
The mean percent change in bone mineral density from baseline to day 112 reported for each arm.
From Day 1 to Day 112
Secondary Outcomes (3)
Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112
From Day 1 to Day 112
Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142
From Day 1 to Day 142
Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142
From Day 1 to Day 142
Study Arms (3)
Treatment Group A: BMS-986036
EXPERIMENTALAdministered as specified on specified days
Treatment Group B: BMS-986036
EXPERIMENTALAdministered as specified on specified days
Treatment Group C: Placebo
PLACEBO COMPARATORAdministered as specified on specified days
Interventions
Eligibility Criteria
You may qualify if:
- Male or female between 21 and 75 years old
- Body Mass Index (BMI) of 25 or more
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Inland Empire Liver Foundation
Rialto, California, 92377, United States
University Of California, San Diego
San Diego, California, 92103, United States
Indiana University Health - University Hospital
Indianapolis, Indiana, 46202, United States
Saint Louis University
St Louis, Missouri, 63104, United States
Unc Hospitals And Clinics
Chapel Hill, North Carolina, 27599-7584, United States
Carolinas Healthcare System
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Upmc Center For Liver Diseases
Pittsburgh, Pennsylvania, 15213, United States
Gastro One
Germantown, Tennessee, 38138, United States
Quality Medical Research PLLC
Nashville, Tennessee, 37211, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
St. Luke'S Episcopal Hospital - Baylor College Of Medicine
Houston, Texas, 77030, United States
Texas Liver Institute
San Antonio, Texas, 78215, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Virginia Commonwealth University
Richmond, Virginia, 23298-0341, United States
Related Publications (1)
Sanyal A, Charles ED, Neuschwander-Tetri BA, Loomba R, Harrison SA, Abdelmalek MF, Lawitz EJ, Halegoua-DeMarzio D, Kundu S, Noviello S, Luo Y, Christian R. Pegbelfermin (BMS-986036), a PEGylated fibroblast growth factor 21 analogue, in patients with non-alcoholic steatohepatitis: a randomised, double-blind, placebo-controlled, phase 2a trial. Lancet. 2019 Dec 22;392(10165):2705-2717. doi: 10.1016/S0140-6736(18)31785-9. Epub 2018 Dec 13.
PMID: 30554783DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2015
First Posted
April 9, 2015
Study Start
May 8, 2015
Primary Completion
January 18, 2017
Study Completion
June 19, 2017
Last Updated
February 26, 2021
Results First Posted
January 28, 2020
Record last verified: 2021-02