drugset / Trial / NCT03922945
A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is being conducted to assess weight loss efficacy, as determined by changes in body mass index (BMI), and safety of VI-0521 (Qsymia®) or placebo, taken for 56 weeks accompanied by a lifestyle modification program in obese adolescents age 12-16 years.
Timeline
- Start
- 2019-05-02
- Primary completion
- 2021-04-16
- Completion
- 2021-04-16
Publications
- Bensignor MO, Freese RL, Rudser KD, Kelly AS, Kunin-Batson A, Gross AC, Bramante C, Shih W, Peterson C, Fox CK. Predictors of BMI reduction with phentermine/topiramate in adolescents with obesity. Int J Obes (Lond). 2025 Sep;49(9):1777-1780. doi: 10.1038/s41366-025-01821-6. Epub 2025 Jun 15.
- Kelly AS, Bensignor MO, Hsia DS, Shoemaker AH, Shih W, Peterson C, Varghese ST. Phentermine/Topiramate for the Treatment of Adolescent Obesity. NEJM Evid. 2022 Jun;1(6):10.1056/evidoa2200014. doi: 10.1056/evidoa2200014. Epub 2022 Apr 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Phentermine | Small molecule | 7.5 mg | Oral |
| Subject | Phentermine | Small molecule | 15 mg | Oral |
| Subject | Topiramate | Small molecule | 46 mg | Oral |
| Subject | Topiramate | Small molecule | 92 mg | Oral |
Indications
No indication recorded.