Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-823778 · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| BMS-823778 (2 mg) | ACTIVE_COMPARATOR | \+ metformin |
| BMS-823778 (10 mg) | ACTIVE_COMPARATOR | \+ metformin |
| BMS-823778 (20 mg) | ACTIVE_COMPARATOR | \+ metformin |
| Placebo | PLACEBO_COMPARATOR | \+ metformin |
| Panel 1: BMS-823778 or Placebo matching BMS-823778 | EXPERIMENTAL | Healthy Subjects |
| Panel 2: BMS-823778 or Placebo matching BMS-823778 | EXPERIMENTAL | Healthy Subjects |
| Panel 3: BMS-823778 or Placebo matching BMS-823778 | EXPERIMENTAL | Healthy Subjects |
| Panel 4: BMS-823778 or Placebo matching BMS-823778 | EXPERIMENTAL | Subjects with T2DM |
| Panel 5: BMS-823778 or Placebo matching BMS-823778 | EXPERIMENTAL | Subjects with T2DM |
| Name | Type | Description |
|---|---|---|
| BMS-823778 | DRUG | Capsules, Oral, 2 mg, once daily, 28 days |
| Placebo | DRUG | Capsules, Oral, 0 mg, once daily, 28 days |
| Metformin | DRUG | Capsules, Oral, ≥ 1500 mg, once daily, 28 days |
| Placebo matching with BMS-823778 | DRUG | Capsules, Oral, 0 mg, Once daily, 14 days |
Inclusion Criteria: * Type 2 diabetes mellitus * Drug naive or on stable metformin therapy * HbA1c 7-10% * FPG ≤ 240mg/dL Exclusion Criteria: * History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack,...
BMS-823778 is an investigational small molecule being developed for metabolic conditions, specifically dyslipidemia and type 2 diabetes mellitus. It has been studied in clinical trials for these indications, including a Phase 2 study in subjects with type 2 diabetes and a Phase 2 study in subjects with hypercholesterolemia.
BMS-823778 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company has conducted clinical trials of this investigational drug in the United States, Australia, Canada, and Japan.
BMS-823778 has completed Phase 2 clinical trials. It is an investigational drug and has not been approved by regulatory authorities. The completed trials include two Phase 2 studies and one Phase 1 study, all of which have been completed.
BMS-823778 has been studied in three completed clinical trials. NCT01111955 was a Phase 2 safety study in subjects with type 2 diabetes. NCT01112423 was a Phase 2 safety study in subjects with hypercholesterolemia. NCT01515202 was a Japanese Phase 1 multiple ascending dose study in healthy volunteers.
BMS-823778 is the only name provided for this investigational drug. No alternative names have been identified in the available clinical trial information. It is a small molecule being developed by Bristol-Myers Squibb for metabolic indications.