CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 223 enrolled
Drug / intervention
VI-0521 oral capsule +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03922945
NCT03922945Phase 4Completed
CompareCT.gov

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

VIVUS LLC·interventional·Posted Apr 22, 2019·Updated Sep 10, 2022

In Brief

A Phase 4 clinical trial evaluating VI-0521 oral capsule, Placebo oral capsule, and 1 other intervention for Adolescent Obesity and 2 related conditions. Completed, enrolled 223 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdolescent Obesity, Obesity in Adolescence, Adolescent Overweight
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedApr 22, 2019
Enrollment StartMay 2, 2019
Primary CompletionApr 16, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.2 years ago

Interventions

VI-0521 oral capsuledrug

Phentermine/Topiramate

Placebo oral capsuledrug

Inactive drug

Lifestyle Modificationbehavioral

The lifestyle modification includes physical activity, behavior change, reduced calorie diet advice, and family support. This intervention is applied to all treatment groups.