A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity
Public ClinicalTrials.gov record NCT03922945. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03922945
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 223 participants
Conditions and interventions
Interventions
- VI-0521 oral capsule Drug
- Placebo oral capsule Drug
- Lifestyle Modification Behavioral
Drug · Behavioral
Eligibility (public fields only)
- Age range
- 12 Years to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 1, 2019
- Primary completion
- Apr 15, 2021
- Completion
- Apr 15, 2021
- Last update posted
- Sep 9, 2022
2019 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Intend Research, LLC | Norman | Oklahoma | 73069 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03922945, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2022 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03922945 live on ClinicalTrials.gov.