NCT03922945View on ClinicalTrials.gov

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

PHASE4CompletedINTERVENTIONAL

Enrollment

223

Participants

Timeline

Start Date

May 2, 2019

Primary Completion Date

April 16, 2021

Study Completion Date

April 16, 2021

Conditions

Adolescent ObesityObesity in AdolescenceAdolescent Overweight

Interventions

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.

Trial Locations (1)

73069

Intend Research, LLC, Norman

All Listed Sponsors

lead

VIVUS LLC

INDUSTRY

NCT03922945 - A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity | Biotech Hunter | Biotech Hunter