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

NCT03922945 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2022-09-10

Study results available
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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

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.

Sponsors & Collaborators

  • VIVUS LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-02
Primary Completion
2021-04-16
Completion
2021-04-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03922945 on ClinicalTrials.gov