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Completed

NCT Number: NCT02413372

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

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

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Key information

Conditions

Non-alcoholic Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Inland Empire Liver Foundation, Rialto, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986036

Drug

Placebo

Drug

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 9, 2015
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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