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 105 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
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
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

Male or female 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 November 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.