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NCT03338296 · ClinicalTrials.gov registry record · Phase 4
Study to Evaluate the Efficacy and Safety of Belviq XR® in Conjunction With Lifestyle Modification for Weight Loss in Obese Adolescents, Age 12 to 17 Years
A Phase 4 study, sponsored by Eisai.
- Terminated
- Registry status
- Phase 4
- Development phase
- 278
- Enrollment target
NCT03338296: Clinical Trial Phase 4 study, sponsored by Eisai.
NCT03338296 is a Phase 4 study that was terminated before completion, run by Eisai. The registered enrollment target is 278 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03338296, a Phase 4 study, was terminated before completion, sponsored by Eisai.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 278 participants
- Enrollment target
Study Summary
This study will be conducted to demonstrate weight loss efficacy by change in body mass index (BMI) and safety in adolescents age 12 to 17 years (inclusive) during 52 weeks of treatment with Belviq XR 20 milligrams (mg) administered once daily (QD) as compared to placebo.
Primary Outcome
BMI is a participant's weight in kilograms divided by the square of height in meters. Change from baseline was calculated as the post-baseline value minus the baseline value.
Interventions
- DRUG Placebo
- DRUG lorcaserin hydrochloride XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 278 participants |
| Start Date | 2017-09-28 |
| Est. Completion | 2020-04-03 |
| Phase | Phase 4 |
Why NCT03338296 stopped before completion
NCT03338296 is an interventional study that assigns participants to a tested intervention. The registered 278 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 (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03338296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03338296 about?
NCT03338296 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Belviq XR® in Conjunction With Lifestyle Modification for Weight Loss in Obese Adolescents, Age 12 to 17 Years". This study will be conducted to demonstrate weight loss efficacy by change in body mass index (BMI) and safety in adolescents age 12 to 17 years (inclusive) during 52 weeks of treatment with Belviq XR 20 milligrams (mg) administered once daily (QD) as compared to placebo.
What is the current status of trial NCT03338296?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 278 participants. The study started on 2017-09-28. Estimated completion is 2020-04-03.
What interventions are being tested in trial NCT03338296?
The interventions under investigation include: Placebo (DRUG), lorcaserin hydrochloride XR (DRUG).
Who is sponsoring clinical trial NCT03338296?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03338296's enrollment target sits among peer trials
278 307th of 2000 higher than 1,691 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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