Phase 2
Completed N=3
A Sub-study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
Source: ClinicalTrials.gov NCT03400163 ↗Enrolled (actual)
3
Serious AEs
—
Results posted
Feb 2020
Primary outcomePrimary: Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 — NA; NA percentage
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 |
NA; NA | — |
| PRIMARY Number of Participants With Adverse Events (AEs) |
NA; NA | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
NA; NA | — |
| PRIMARY Number of Participants With Injection Site Reactions |
NA; NA; NA; NA; NA; NA | — |
| PRIMARY Number of Participants With Adverse Events Leading to Discontinuation |
NA; NA | — |
| PRIMARY Number of Deaths |
NA; NA | — |
| PRIMARY Number of Participants With Marked Laboratory Abnormalities |
NA; NA; NA; NA | — |
| PRIMARY Number of Participants With Vital Sign Abnormalities |
NA; NA | — |
| PRIMARY Number of Participants With Electrocardiogram (ECG) Abnormalities |
NA; NA; NA; NA; NA; NA | — |
| PRIMARY Number of Participants With Physical Examination Abnormalities |
NA; NA | — |
| PRIMARY Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) |
NA; NA | — |
| SECONDARY Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112 |
NA; NA; NA; NA | — |
| SECONDARY Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142 |
NA; NA | — |
| SECONDARY Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142 |
NA; NA | — |
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
Data sourced from ClinicalTrials.gov (NCT03400163). 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. Informational only — not medical advice.