Trial · NCT00603291

BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus

NCT00603291, 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-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus. Trials, record NCT00603291. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00603291

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus
NCT number: NCT00603291
Status: Completed
Phases: Phase 3
Enrollment: 604 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: 2019-10-02
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	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 BID	37.5		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 QD	44.7		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	16.1		percentage of participants
Percent Change in Body Weight From Baseline to Week 52	Lorcaserin 10 mg BID	-4.54	Standard Error 0.35	% change from baseline: body wt (kg)
Percent Change in Body Weight From Baseline to Week 52	Lorcaserin 10 mg QD	-4.97	Standard Error 0.54	% change from baseline: body wt (kg)
Percent Change in Body Weight From Baseline to Week 52	Matching Placebo	-1.48	Standard Error 0.36	% 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
Overall Study	STARTED	Lorcaserin 10 mg Once Daily (QD)	95
Overall Study	STARTED	Lorcaserin 10 mg Twice a Day (BID)	256
Overall Study	STARTED	Matching Placebo	253
Overall Study	COMPLETED	Lorcaserin 10 mg Once Daily (QD)	75
Overall Study	COMPLETED	Lorcaserin 10 mg Twice a Day (BID)	169
Overall Study	COMPLETED	Matching Placebo	157
Overall Study	NOT COMPLETED	Lorcaserin 10 mg Once Daily (QD)	20
Overall Study	NOT COMPLETED	Lorcaserin 10 mg Twice a Day (BID)	87
Overall Study	NOT COMPLETED	Matching Placebo	96

Source ClinicalTrials.gov

Adverse events192

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 BID	24	256	26
other	Nausea	Gastrointestinal disorders	Lorcaserin 10 mg QD	8	95	8
other	Nausea	Gastrointestinal disorders	Matching Placebo	20	252	27
other	Diarrhoea	Gastrointestinal disorders	Lorcaserin 10 mg BID	19	256	19
other	Diarrhoea	Gastrointestinal disorders	Lorcaserin 10 mg QD	13	95	16
other	Diarrhoea	Gastrointestinal disorders	Matching Placebo	19	252	23
other	Constipation	Gastrointestinal disorders	Lorcaserin 10 mg BID	11	256	11
other	Constipation	Gastrointestinal disorders	Lorcaserin 10 mg QD	6	95	8
other	Constipation	Gastrointestinal disorders	Matching Placebo	12	252	14
other	Fatigue	General disorders	Lorcaserin 10 mg BID	19	256	19

1 to 10 of 192Source ClinicalTrials.gov

See all 192 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lorcaserin 10 mg BID
Total, all-cause mortality	Lorcaserin 10 mg QD
Total, all-cause mortality	Matching Placebo
Total, other adverse events	Lorcaserin 10 mg BID	236	256
Total, other adverse events	Lorcaserin 10 mg QD	89	95
Total, other adverse events	Matching Placebo	213	252
Total, serious adverse events	Lorcaserin 10 mg BID	16	256
Total, serious adverse events	Lorcaserin 10 mg QD	8	95
Total, serious adverse events	Matching Placebo	17	252

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22421927	DERIVED	PubMed
23661689	DERIVED	PubMed
27206567	DERIVED	PubMed
27389084	DERIVED	PubMed
27659698	DERIVED	PubMed
27888609	DERIVED	PubMed
28345809	DERIVED	PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00603291

GET https://conductscience.org/api/trials/v1/NCT00603291/events?page=2

API reference For AI assistants