Overview

This trial is active, not recruiting.

Condition non-alcoholic steatohepatitis
Treatments bms-986036, placebo
Phase phase 2
Sponsor Bristol-Myers Squibb
Start date May 2015
End date January 2017
Trial size 202 participants
Trial identifier NCT02413372, MB130-045

Summary

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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking participant, investigator
Arm
(Experimental)
Administered as specified on specified days
bms-986036
(Experimental)
Administered as specified on specified days
bms-986036
(Placebo Comparator)
Administered as specified on specified days
placebo
(Experimental)
Administered as specified on specified days
bms-986036
(Placebo Comparator)
Administered as specified on specified days
placebo

Primary Outcomes

Measure
Change in percent hepatic fat fraction (%) by Magnetic Resonance Imaging (MRI)
time frame: From screening/baseline to week 16
Safety, as measured by adverse events (AEs)
time frame: From screening/baseline, subsequent days after, upto week 16
Safety, as measured by clinical laboratory tests
time frame: From screening/baseline, subsequent days after, upto week 16
Safety, as measured by vital signs
time frame: From screening/baseline, subsequent days after, upto week 16
Safety, as measured by electrocardiograms
time frame: From screening/baseline, subsequent days after, upto week 16
Safety, as measured by physical examinations
time frame: From screening/baseline, subsequent days after, upto week 16
Safety, as measured by bone mineral density
time frame: From screening/baseline, subsequent days after, upto week 16

Secondary Outcomes

Measure
BMS-986036 observed concentration by Ctrough
time frame: From Day 1 to Day 142
Anti-BMS-986036 antibodies
time frame: From Day 1 to Day 142

Eligibility Criteria

All participants from 21 years up to 75 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.