A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity

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

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs VI-0521 Mid Dose vs VI-0521 Top Dose; p <0.0001; Mixed Models Analysis NCT03922945 ↗

paper differences from placebo of -10.44 percentage points (95% CI, -13.89 to -6.99; P<0.001) PMID 36968652 ↗

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.