Trial · NCT00395135
BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management
NCT00395135, Phase 3, Completed, Eisai Inc.; results first posted 2013-02-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management. Trials, record NCT00395135. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00395135
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management
- NCT number
- NCT00395135
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,182 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Obesity
- Interventions
- Lorcaserin 10 mg BID, Matching Placebo BID
- First posted
- 2006-11-02
- Last updated
- 2019-10-02
- Results first posted
- 2013-02-07
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 | 52 weeks | The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1. Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1. |
| Primary | Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104 | 104 weeks | The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1 and who maintained this reduction during year 2. |
| Secondary | Year 1: Percent Change in Body Weight From Baseline to Week 52 | 52 weeks | Year 1: The % change in body weight (kg) from baseline to week 52. |
| Secondary | Year 2: Percent Change in Body Weight From Week 52 to Week 104 | 52 weeks | Year 2: The % change in body weight (kg) from week 52 to week 104. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 | 52 weeks | MITT with LOCF | percentage of participants | NUMBER |
| PRIMARY | Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104 | 104 weeks | MITT with LOCF | percentage of participants | NUMBER |
| SECONDARY | Year 1: Percent Change in Body Weight From Baseline to Week 52 | 52 weeks | MITT with LOCF | % change from baseline: body wt (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Year 2: Percent Change in Body Weight From Week 52 to Week 104 | 52 weeks | MITT with LOCF | % change from baseline: body wt (kg) | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 | Lorcaserin 10 mg BID | 47.5 | percentage of participants | ||
| Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 | Matching Placebo BID | 20.3 | percentage of participants | ||
| Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104 | Lorcaserin 10 mg BID (Yr 1) / Lorcaserin 10 mg BID (Yr 2) | 67.9 | percentage of participants | ||
| Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104 | Lorcaserin 10 mg BID (Yr 1) / Matching Placebo (Yr 2) | 50.3 | percentage of participants | ||
| Year 1: Percent Change in Body Weight From Baseline to Week 52 | Lorcaserin 10 mg BID | -5.87 | Standard Error 0.18 | % change from baseline: body wt (kg) | |
| Year 1: Percent Change in Body Weight From Baseline to Week 52 | Matching Placebo BID | -2.20 | Standard Error 0.18 | % change from baseline: body wt (kg) | |
| Year 2: Percent Change in Body Weight From Week 52 to Week 104 | Lorcaserin 10 mg BID (Yr 1) / Lorcaserin 10 mg BID (Yr 2) | 2.79 | Standard Error 0.23 | % change from baseline: body wt (kg) | |
| Year 2: Percent Change in Body Weight From Week 52 to Week 104 | Lorcaserin 10 mg BID (Yr 1) / Matching Placebo (Yr 2) | 5.38 | Standard Error 0.31 | % change from baseline: body wt (kg) | |
| Year 2: Percent Change in Body Weight From Week 52 to Week 104 | Placebo (Yr 1) / Placebo (Yr 2) | 1.15 | Standard Error 0.22 | % change from baseline: body wt (kg) |
Source ClinicalTrials.gov
Participant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Year 1 | STARTED | Year 1 - Lorcaserin 10 mg BID | 1,595 | |
| Year 1 | STARTED | Year 1 - Matching Placebo BID | 1,587 | |
| Year 1 | STARTED | Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2) | 0 | |
| Year 1 | STARTED | Year 2 - Lorc 10 mg BID (Yr 1) / Placebo (Yr 2) | 0 | |
| Year 1 | STARTED | Year 2 - Placebo (Yr 1) / Placebo (Yr 2) | 0 | |
| Year 1 | COMPLETED | Year 1 - Lorcaserin 10 mg BID | 883 | |
| Year 1 | COMPLETED | Year 1 - Matching Placebo BID | 716 | |
| Year 1 | COMPLETED | Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2) | 0 | |
| Year 1 | COMPLETED | Year 2 - Lorc 10 mg BID (Yr 1) / Placebo (Yr 2) | 0 | |
| Year 1 | COMPLETED | Year 2 - Placebo (Yr 1) / Placebo (Yr 2) | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events575
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 | Arthralgia | Musculoskeletal and connective tissue disorders | Year 1 - Lorcaserin 10 mg BID | 70 | 1,593 | 79 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Year 1 - Matching Placebo BID | 75 | 1,584 | 87 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2) | 38 | 573 | 44 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2) | 17 | 283 | 18 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Year 2 - Placebo (Yr 1) / Placebo (Yr 2) | 43 | 697 | 51 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Year 1 - Lorcaserin 10 mg BID | 99 | 1,593 | 114 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Year 1 - Matching Placebo BID | 89 | 1,584 | 93 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2) | 34 | 573 | 39 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2) | 16 | 283 | 19 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Year 2 - Placebo (Yr 1) / Placebo (Yr 2) | 30 | 697 | 33 |
1 to 10 of 575Source ClinicalTrials.gov
See all 575 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Year 1 - Lorcaserin 10 mg BID | ||
| Total, all-cause mortality | Year 1 - Matching Placebo BID | ||
| Total, all-cause mortality | Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2) | ||
| Total, all-cause mortality | Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2) | ||
| Total, all-cause mortality | Year 2 - Placebo (Yr 1) / Placebo (Yr 2) | ||
| Total, other adverse events | Year 1 - Lorcaserin 10 mg BID | 1,324 | 1,593 |
| Total, other adverse events | Year 1 - Matching Placebo BID | 1,203 | 1,584 |
| Total, other adverse events | Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2) | 450 | 573 |
| Total, other adverse events | Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2) | 210 | 283 |
| Total, other adverse events | Year 2 - Placebo (Yr 1) / Placebo (Yr 2) | 515 | 697 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers6
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/NCT00395135
GET https://conductscience.org/api/trials/v1/NCT00395135/flow?page=2