Trial · NCT00603902
BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management
NCT00603902, Phase 3, Completed, Eisai Inc.; results first posted 2013-02-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management. Trials, record NCT00603902. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00603902
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management
- NCT number
- NCT00603902
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,008 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Obesity
- Interventions
- Lorcaserin 10 mg once daily (QD), Lorcaserin 10 mg twice a day (BID), Matching Placebo
- First posted
- 2008-01-29
- Last updated
- 2019-10-04
- Results first posted
- 2013-02-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 | Baseline and Week 52 | The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks. |
| Secondary | Percent Change in Body Weight From Baseline to Week 52 | Baseline and Week 52 | The percent change in body weight (kg) from baseline to week 52. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 | Baseline and Week 52 | Modified Intent to Treat (MITT) with last observation carried forward (LOCF) | percentage of participants | NUMBER |
| SECONDARY | Percent Change in Body Weight From Baseline to Week 52 | Baseline and Week 52 | MITT with LOCF | % change from baseline: body wt (kg) | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 | Lorcaserin 10 mg QD | 40.2 | percentage of participants | ||
| Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 | Lorcaserin 10 mg BID | 47.2 | percentage of participants | ||
| Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 | Matching Placebo | 25.0 | percentage of participants | ||
| Percent Change in Body Weight From Baseline to Week 52 | Lorcaserin 10 mg QD | -4.75 | Standard Error 0.23 | % change from baseline: body wt (kg) | |
| Percent Change in Body Weight From Baseline to Week 52 | Lorcaserin 10 mg BID | -5.84 | Standard Error 0.16 | % change from baseline: body wt (kg) | |
| Percent Change in Body Weight From Baseline to Week 52 | Matching Placebo | -2.84 | Standard Error 0.16 | % change from baseline: body wt (kg) |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lorcaserin 10 mg QD | 802 | |
| Overall Study | STARTED | Lorcaserin 10 mg BID | 1,603 | |
| Overall Study | STARTED | Matching Placebo | 1,603 | |
| Overall Study | COMPLETED | Lorcaserin 10 mg QD | 473 | |
| Overall Study | COMPLETED | Lorcaserin 10 mg BID | 917 | |
| Overall Study | COMPLETED | Matching Placebo | 834 | |
| Overall Study | NOT COMPLETED | Lorcaserin 10 mg QD | 329 | |
| Overall Study | NOT COMPLETED | Lorcaserin 10 mg BID | 686 | |
| Overall Study | NOT COMPLETED | Matching Placebo | 769 |
Source ClinicalTrials.gov
Adverse events369
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Lorcaserin 10 mg QD | 61 | 801 | 68 |
| other | Nausea | Gastrointestinal disorders | Lorcaserin 10 mg BID | 145 | 1,602 | 160 |
| other | Nausea | Gastrointestinal disorders | Matching Placebo | 85 | 1,601 | 96 |
| other | Diarrhoea | Gastrointestinal disorders | Lorcaserin 10 mg QD | 53 | 801 | 59 |
| other | Diarrhoea | Gastrointestinal disorders | Lorcaserin 10 mg BID | 98 | 1,602 | 119 |
| other | Diarrhoea | Gastrointestinal disorders | Matching Placebo | 94 | 1,601 | 106 |
| other | Constipation | Gastrointestinal disorders | Lorcaserin 10 mg QD | 41 | 801 | 44 |
| other | Constipation | Gastrointestinal disorders | Lorcaserin 10 mg BID | 80 | 1,602 | 91 |
| other | Constipation | Gastrointestinal disorders | Matching Placebo | 61 | 1,601 | 62 |
| other | Dry mouth | Gastrointestinal disorders | Lorcaserin 10 mg QD | 27 | 801 | 29 |
1 to 10 of 369Source ClinicalTrials.gov
See all 369 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lorcaserin 10 mg QD | ||
| Total, all-cause mortality | Lorcaserin 10 mg BID | ||
| Total, all-cause mortality | Matching Placebo | ||
| Total, other adverse events | Lorcaserin 10 mg QD | 653 | 801 |
| Total, other adverse events | Lorcaserin 10 mg BID | 1,323 | 1,602 |
| Total, other adverse events | Matching Placebo | 1,205 | 1,601 |
| Total, serious adverse events | Lorcaserin 10 mg QD | 27 | 801 |
| Total, serious adverse events | Lorcaserin 10 mg BID | 49 | 1,602 |
| Total, serious adverse events | Matching Placebo | 36 | 1,601 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00603902
GET https://conductscience.org/api/trials/v1/NCT00603902/events?page=2