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NCT03922945 · ClinicalTrials.gov registry record · Phase 4
A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity
A Phase 4 study, sponsored by VIVUS.
- Completed
- Registry status
- Phase 4
- Development phase
- 223
- Enrollment target
NCT03922945: Completed Phase 4 study, sponsored by VIVUS.
NCT03922945 is a Phase 4 study that has completed, run by VIVUS. The registered enrollment target is 223 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03922945, a Phase 4 study, has completed, sponsored by VIVUS.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 223 participants
- Enrollment target
Study 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.
Primary Outcome
Mean % change in BMI from Baseline to Week 56
Interventions
- DRUG Placebo oral capsule
- BEHAVIORAL Lifestyle Modification
- DRUG VI-0521 oral capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2019-05-02 |
| Est. Completion | 2021-04-16 |
| Phase | Phase 4 |
What the finished NCT03922945 record still lists
NCT03922945 is an interventional study that assigns participants to a tested intervention. The registered 223 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo oral capsule is the first listed.
NCT03922945 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03922945 about?
NCT03922945 is a clinical study titled "A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity". 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.
What is the current status of trial NCT03922945?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 223 participants. The study started on 2019-05-02. Estimated completion is 2021-04-16.
What interventions are being tested in trial NCT03922945?
The interventions under investigation include: Placebo oral capsule (DRUG), Lifestyle Modification (BEHAVIORAL), VI-0521 oral capsule (DRUG).
Who is sponsoring clinical trial NCT03922945?
This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03922945's enrollment target sits among peer trials
223 383rd of 2000 higher than 1,618 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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