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

Phase 2

Completed

• Conditions: Non-Alcoholic Steatohepatitis
• Interventions: Drug: Placebo; Drug: BMS-986036

• Registration Number: NCT03400163
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this sub-study of MB130-045 is to determine the pharmacokinetic effects, pharmacodynamic effects, efficacy and safety of BMS-986036 20 mg QD in subjects with Non-alcoholic Steatohepatitis (NASH)

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-05-08
• Primary Completion: 2017-01-18
• Study Completion: 2017-06-19
• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-17
• Disposition First Submitted: 2018-01-17
• Disposition First Submitted QC: 2018-01-17
• Disposition First Posted: 2018-01-19
• Results First Submitted: 2020-01-16
• Results First Submitted QC: 2020-02-07
• Results First Posted: 2020-02-19
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Male or female between 21 and 75 years old
• Body Mass Index (BMI) of 25 or more

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group E:	Placebo	Administered as specified on specified days
Treatment Group D:	BMS-986036	Administered as specified on specified days

Primary Outcome Measures

Name	Time	Method
Number of Participants With Physical Examination Abnormalities	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.
Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16	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.
Number of Participants With Adverse Events (AEs)	From first dose to date of last dose plus 30 days	The number of participants with on-study AEs was reported for each arm.
Number of Participants With Serious Adverse Events (SAEs)	From first dose to date of last dose plus 30 days	The number of participants with on-study SAEs was reported for each arm.
Number of Participants With Injection Site Reactions	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.
Number of Participants With Adverse Events Leading to Discontinuation	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.
Number of Deaths	From first dose to date of last dose plus 30 days	The number of deaths was reported for each arm.
Number of Participants With Marked Laboratory Abnormalities	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.
Number of Participants With Vital Sign Abnormalities	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.
Number of Participants With Electrocardiogram (ECG) Abnormalities	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.
Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA)	From Day 1 to Day 112	The mean percent change in bone mineral density from baseline to day 112 reported for each arm.

Secondary Outcome Measures

Name	Time	Method
Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112	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.
Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142	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.
Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142	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.

Trial Locations

Locations (2)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States