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

Non-Alcoholic Steatohepatitis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Sub-study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-986036 in Adults With Non-alcoholic Steatohepatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400163
• Other study ID #: MB130-045 A
• Status: Completed
• Phase: Phase 2
• Start date: May 8, 2015
• Est. completion date: June 19, 2017

Study information

• Verified date: February 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: June 19, 2017
• Est. primary completion date: January 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Non-Alcoholic Steatohepatitis

Intervention

Drug:
• BMS-986036
BMS-986036 20 mg QD
• Placebo
Placebo QD

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Texas Liver Institute	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of Deaths	The number of deaths was reported for each arm.	From first dose to date of last dose plus 30 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at 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.	From Day 1 to Day 112
Secondary	Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at 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.	From Day 1 to Day 142
Secondary	Number of Participants With Positive Anti-FGF21 Antibody Response at 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.	From Day 1 to Day 142

External Links

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