Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sibutramine · 5 trials · 3 indications
For each subject, POE status (with/without an event) and time to first occurrence of a POE using time-to-event analysis were evaluated. All POE confirmed by an independent adjudication committee were included in the analysis.
| Arm | Type | Description |
|---|---|---|
| Sibutramine | EXPERIMENTAL | Subjects were randomized to receive sibutramine 10 mg once daily (QD) during the Treatment Period after a 6-week Lead-in Period |
| Placebo | PLACEBO_COMPARATOR | Subjects were randomized to receive placebo QD during the Treatment Period after a 6-week Lead-in Period |
| Lead-in sibutramine | EXPERIMENTAL | All subjects received 10 mg sibutramine QD during a 6-week Lead-in Period |
| 1 | ACTIVE_COMPARATOR | - |
| 2 | PLACEBO_COMPARATOR | - |
| 3 | ACTIVE_COMPARATOR | felodipine/ramipril |
| Name | Type | Description |
|---|---|---|
| Sibutramine hydrochloride | DRUG | One 10 mg tablet QD plus country-specific standard care for weight management. (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.) |
| Placebo | DRUG | 1 tablet QD plus country-specific standard care for weight management (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.) |
| Sibutramine | DRUG | Capsules, Wk 0: 10mg, once daily; Wks 4-24: 10mg or 15mg, once daily, dosage escalation based upon investigator's assessment. |
| verapamil/trandolapril | DRUG | 2 wk Run-in phase, antihypertensive therapy only |
| metoprolol/HCT | DRUG | 2 wk Run-in phase, antihypertensive therapy only |
| felodipine/ramipril | DRUG | 2 wk Run-in phase, antihypertensive therapy only |
Inclusion Criteria: * Subject's body mass index (BMI) was \>= 27 kg/m(2) and \<= 45 kg/m(2) or their BMI was \>= 25 kg/m(2) and \< 27 kg/m(2) with waist circumference of \>= 102 cm in males or \>= 88 cm in females. * Medical history positive for: * Preexisting cardiovascular disease (i.e., coron...
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Sibutramine is an investigational small molecule being studied for the treatment of obesity and binge eating disorder. It is being developed by Abbott Laboratories (ABT) and has completed Phase 3 clinical trials, though it is not yet approved and remains in clinical development.
Sibutramine is a small molecule that acts on the central nervous system to regulate appetite. Its mechanism involves inhibiting the reuptake of neurotransmitters, which helps promote satiety and reduce food intake, supporting its use in weight management for obesity.
Sibutramine is being developed by Abbott Laboratories, a company publicly traded under the ticker ABT. The drug is currently in Phase 3 clinical development for obesity and binge eating disorder, with all four completed trials sponsored by the company.
Sibutramine is in Phase 3 clinical development. It has completed four Phase 3 trials, including a large cardiovascular outcomes study with over 10,000 participants. The drug is investigational and has not received FDA approval, as it remains under clinical evaluation.
Sibutramine has completed four Phase 3 trials. Key studies include NCT00234832, a long-term cardiovascular outcomes trial in 10,777 obese patients; NCT00261911 in overweight adolescents; NCT00677391 in a Malaysian population; and NCT00679653 in obese hypertensives. All trials are completed.
Sibutramine is the generic name for the drug formerly marketed as Meridia, which was withdrawn from the market. However, the current clinical development program by Abbott Laboratories is investigating sibutramine as an investigational compound for obesity and binge eating disorder.