Phase 2 N=75 Randomized Double-blind Treatment

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

Non-Alcoholic Steatohepatitis

Bottom Line

View on ClinicalTrials.gov: NCT02413372 ↗

Enrolled (actual)

Serious AEs

2.7%

Results posted

Jan 2020

Primary outcome: Primary: Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 — -8.43; -6.45; -1.26; -6.77 percentage — p=0.0004

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: BMS-986036 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Jan 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16	-8.43; -6.45; -1.26; -6.77; -5.20; -1.35	0.0004 sig
PRIMARY Number of Participants With Adverse Events (AEs)	18; 13; 15	—
PRIMARY Number of Participants With Serious Adverse Events (SAEs)	1; 0; 1	—
PRIMARY Number of Participants With Injection Site Reactions	2; 2; 0; 1; 1; 1	—
PRIMARY Number of Participants With Adverse Events Leading to Discontinuation	0; 0; 0	—
PRIMARY Number of Deaths	0; 0; 0	—
PRIMARY Number of Participants With Marked Laboratory Abnormalities	1; 1; 2; 0; 1; 0	—
PRIMARY Number of Participants With Vital Sign Abnormalities	17; 16; 14	—
PRIMARY Number of Participants With Electrocardiogram (ECG) Abnormalities	2; 1; 2; 1; 0; 3	—
PRIMARY Number of Participants With Physical Examination Abnormalities	11; 9; 12	—
PRIMARY Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA)	-2.79; -1.08; -0.11; -0.91; -1.10; -0.93	—
SECONDARY Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112	162; 10.9; NA; 3250; 1130; NA	—
SECONDARY Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142	23; 15; 0	—
SECONDARY Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142	23; 15; 0	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02413372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.