BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management
1 other identifier
interventional
3,182
1 country
1
Brief Summary
The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight loss at the end of the second year of treatment (Week 104)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Nov 2006
Typical duration for phase_3 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedFirst Posted
Study publicly available on registry
November 2, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
February 7, 2013
CompletedOctober 2, 2019
January 1, 2013
2.3 years
October 31, 2006
January 4, 2013
September 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52
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.
52 weeks
Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104
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.
104 weeks
Secondary Outcomes (2)
Year 1: Percent Change in Body Weight From Baseline to Week 52
52 weeks
Year 2: Percent Change in Body Weight From Week 52 to Week 104
52 weeks
Study Arms (2)
Lorcaserin 10 mg BID
EXPERIMENTALLorcaserin 10 mg tablet each morning and evening
Matching Placebo BID
PLACEBO COMPARATORMatching placebo tablet each morning and evening
Interventions
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks.
Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks.
Eligibility Criteria
You may qualify if:
- Obese adults with a BMI 30 to 45 kg/m2 or overweight adults with a BMI 27 to 29.9 kg/m2 and at least one obesity-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, glucose intolerance, sleep apnea)
- Ability to complete a 2 year study
You may not qualify if:
- Diabetes
- Pregnancy
- History of heart valve disease
- Serious or unstable current or past medical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (1)
Arena Pharmaceuticals, Inc.
San Diego, California, 92121, United States
Related Publications (6)
Weissman NJ, Smith SR, Fain R, Hall N, Shanahan WR. Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials. Obesity (Silver Spring). 2017 Jan;25(1):39-44. doi: 10.1002/oby.21695. Epub 2016 Nov 26.
PMID: 27888609DERIVEDHandelsman Y, Fain R, Wang Z, Li X, Fujioka K, Shanahan W. Lorcaserin treatment allows for decreased number needed to treat for weight and glycemic parameters in week 12 responders with >/=5% weight loss. Postgrad Med. 2016 Nov;128(8):740-746. doi: 10.1080/00325481.2016.1240591. Epub 2016 Oct 19.
PMID: 27659698DERIVEDNguyen CT, Zhou S, Shanahan W, Fain R. Lorcaserin in Obese and Overweight Patients Taking Prohibited Serotonergic Agents: A Retrospective Analysis. Clin Ther. 2016 Jun;38(6):1498-1509. doi: 10.1016/j.clinthera.2016.04.004. Epub 2016 May 17.
PMID: 27206567DERIVEDNesto R, Fain R, Li Y, Shanahan W. Evaluation of lorcaserin on progression of prediabetes to type 2 diabetes and reversion to euglycemia. Postgrad Med. 2016 May;128(4):364-70. doi: 10.1080/00325481.2016.1178590.
PMID: 27116910DERIVEDWeissman NJ, Sanchez M, Koch GG, Smith SR, Shanahan WR, Anderson CM. Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials. Circ Cardiovasc Imaging. 2013 Jul;6(4):560-7. doi: 10.1161/CIRCIMAGING.112.000128. Epub 2013 May 9.
PMID: 23661689DERIVEDSmith SR, Weissman NJ, Anderson CM, Sanchez M, Chuang E, Stubbe S, Bays H, Shanahan WR; Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM) Study Group. Multicenter, placebo-controlled trial of lorcaserin for weight management. N Engl J Med. 2010 Jul 15;363(3):245-56. doi: 10.1056/NEJMoa0909809.
PMID: 20647200DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eisai Medical Information
- Organization
- Eisai Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2006
First Posted
November 2, 2006
Study Start
November 1, 2006
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
October 2, 2019
Results First Posted
February 7, 2013
Record last verified: 2013-01