NCT03922945

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

A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Determine the Safety and Efficacy of VI-0521 in Obese Adolescents

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: All
• Age: 12 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adolescent Obesity
• Obesity in Adolescence
• Adolescent Overweight

Interventions

Type	Name	Description
DRUG	VI-0521 oral capsule	Phentermine/Topiramate
DRUG	Placebo oral capsule	Inactive drug
BEHAVIORAL	Lifestyle Modification	The lifestyle modification includes physical activity, behavior change, reduced calorie diet advice, and family support. This intervention is applied to all treatment groups.

Timeline

• Start date: 2019-05-02
• Primary completion: 2021-04-16
• Completion: 2021-04-16
• First posted: 2019-04-22
• Last updated: 2022-09-10
• Results posted: 2022-09-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study