Clinical Trial Details
| Trial ID: | L0240 |
| Source ID: | NCT02413372 |
| Associated Drug: | BMS-986036 |
| Title: | A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH) |
| Acronym: | -- |
| Status: | Completed |
| Study Results: | Has Results |
| Results: | https://ClinicalTrials.gov/show/NCT02413372/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: | 184 |
| 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: | January 28, 2020 |
| Last Update Posted: | February 26, 2021 |
| Locations: | Inland Empire Liver Foundation, Rialto, California, United States|University Of California, San Diego, San Diego, California, United States|Indiana University Health - University Hospital, Indianapolis, Indiana, United States|Saint Louis University, Saint Louis, Missouri, United States|Unc Hospitals And Clinics, Chapel Hill, North Carolina, United States|Carolinas Healthcare System, Charlotte, North Carolina, United States|Duke University Medical Center, Durham, North Carolina, United States|Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States|Upmc Center For Liver Diseases, Pittsburgh, Pennsylvania, United States|Gastro One, Germantown, Tennessee, United States|Quality Medical Research PLLC, Nashville, Tennessee, United States|Texas Clinical Research Institute, LLC, Arlington, Texas, United States|Brooke Army Medical Center, Fort Sam Houston, Texas, United States|St. Luke'S Episcopal Hospital - Baylor College Of Medicine, Houston, Texas, United States|Texas Liver Institute, San Antonio, Texas, United States|Digestive and Liver Disease Specialists, Norfolk, Virginia, United States|Virginia Commonwealth University, Richmond, Virginia, United States |
| URL: | https://ClinicalTrials.gov/show/NCT02413372 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D046 | Pegbelfermin | Biological drug | DB15365 | FGF21 analog | Improve insulin resistance; Enhance lipid metabolism; Anti-fibrosis | Under clinical trials | Details |
| D094 | Cysteamine | Chemical drug | DB00847 | GSS stimulant | Renal drug | Under clinical trials | Details |
| D095 | Cysteamine bitartrate | Chemical drug | DB00847 | -- | -- | Under clinical trials | Details |
| D248 | Obeticholic Acid | Chemical drug | DB05990 | NR1H4 activator; NR1H4 agonist; FXR agonist | Enhance lipid metabolism | Approval rejected | Details |
| D328 | Serine | Chemical drug | DB00133 | SRR | Improve insulin resistance | Under clinical trials | Details |