drugset / Trial / NCT04095104
Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds
Phase 2
Completed
13 enrolled
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collabUniversity of Colorado- Clinical and Translational Sciences Institute · collabUniversity of Colorado- Nutrition Obesity Research Center · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The goal of this pilot study is to establish the feasibility and initial efficacy of the combination of phentermine and topiramate for adolescents and young adults who require additional risk reduction after bariatric surgery. This study will use a randomized, placebo-controlled, double-blinded design to evaluate an adjunctive 12-week intervention of phentermine + topiramate + standard of care vs. placebos + standard of care 6 months after bariatric surgery, among 12 to 24 year olds who don't achieve expected weight loss or who remain severely obese (n=10 total).
Timeline
- Start
- 2020-01-15
- Primary completion
- 2022-01-25
- Completion
- 2022-01-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Phentermine | Small molecule | 16 mg | — |
| Subject | Topiramate | Small molecule | 100 mg | — |