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NCT00603291 · ClinicalTrials.gov registry record · Phase 3
BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus
A Phase 3 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 604
- Enrollment target
NCT00603291: Completed Phase 3 study, sponsored by Eisai.
NCT00603291 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 604 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00603291, a Phase 3 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 604 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral hypoglycemic agents.
Primary Outcome
The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.
Interventions
- DRUG Matching Placebo
- DRUG Lorcaserin 10 mg once daily (QD)
- DRUG Lorcaserin 10 mg twice a day (BID)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 604 participants |
| Start Date | 2007-12 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
What the finished NCT00603291 record still lists
NCT00603291 is an interventional study that assigns participants to a tested intervention. The registered 604 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 3 interventions - of which Matching Placebo is the first listed.
NCT00603291 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00603291 about?
NCT00603291 is a clinical study titled "BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus". The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral hypoglycemic agents.
What is the current status of trial NCT00603291?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 604 participants. The study started on 2007-12. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00603291?
The interventions under investigation include: Matching Placebo (DRUG), Lorcaserin 10 mg once daily (QD) (DRUG), Lorcaserin 10 mg twice a day (BID) (DRUG).
Who is sponsoring clinical trial NCT00603291?
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 NCT00603291's enrollment target sits among peer trials
604 607th of 2000 higher than 1,394 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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