| Trial ID: | L0211 |
| Source ID: | NCT03400163
|
| Associated Drug: |
BMS-986036
|
| Title: |
A Sub-study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
Has Results
|
| Results: |
https://ClinicalTrials.gov/show/NCT03400163/results
|
| Conditions: |
Non-Alcoholic Steatohepatitis
|
| Interventions: |
Drug: BMS-986036|Drug: Placebo
|
| Outcome Measures: |
Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16|Number of Participants With Adverse Events (AEs)|Number of Participants With Serious Adverse Events (SAEs)|Number of Participants With Injection Site Reactions|Number of Participants With Adverse Events Leading to Discontinuation|Number of Deaths|Number of Participants With Marked Laboratory Abnormalities|Number of Participants With Vital Sign Abnormalities|Number of Participants With Electrocardiogram (ECG) Abnormalities|Number of Participants With Physical Examination Abnormalities|Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA)|Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112|Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142|Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142
|
| Sponsor/Collaborators: |
Bristol-Myers Squibb
|
| Gender: |
All
|
| Age: |
21 Years to 75 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
3
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
|
| Start Date: |
May 8, 2015
|
| Completion Date: |
June 19, 2017
|
| Results First Posted: |
February 19, 2020
|
| Last Update Posted: |
February 26, 2021
|
| Locations: |
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States|Texas Liver Institute, San Antonio, Texas, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT03400163
|
