drugset / Trial / NCT05209984
A Phase 3, Double-blind/Double-dummy, Safety/Efficacy/Superiority of Sibutramine/Topiramate XR in Adults With Overweight
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A phase 3, multicenter, randomized, double-blind, double-dummy, parallel-group, active-drug- and placebo-controlled clinical trial to assess the safety, efficacy and superiority of the new fixed-dose combination sibutramine IR/topyramat XR in weight reduction in overweight adults with comorbidity(ies) or obesity
Timeline
- Start
- 2026-04
- Primary completion
- 2028-03
- Completion
- 2028-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sibutramine | Small molecule | 15 mg | Oral |
| Subject | Topiramate | Small molecule | 75 mg | Oral |
| Subject | Topiramate | Small molecule | 100 mg | Oral |