BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management
A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients
1 other identifier
interventional
4,008
1 country
1
Brief 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.
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 Jan 2008
Shorter than P25 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
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 16, 2008
CompletedFirst Posted
Study publicly available on registry
January 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
February 7, 2013
CompletedOctober 4, 2019
August 1, 2019
1.5 years
January 16, 2008
January 4, 2013
September 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52
The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.
Baseline and Week 52
Secondary Outcomes (1)
Percent Change in Body Weight From Baseline to Week 52
Baseline and Week 52
Study Arms (3)
Lorcaserin 10 mg QD
EXPERIMENTALLorcaserin 10 mg tablet each morning and placebo tablet each evening
Lorcaserin 10 mg BID
EXPERIMENTALLorcaserin 10 mg tablet each morning and evening
Matching Placebo
PLACEBO COMPARATORMatching placebo tablet each morning and evening
Interventions
Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
Matching placebo tablet each morning and evening for a duration of 52 weeks.
Eligibility Criteria
You may qualify if:
- Overweight and/or obese men and women with a body mass index (BMI) 30 to 45 kg/m2 with or without a comorbid condition (e.g., hypertension, dyslipidemia, CV disease, glucose intolerance, sleep apnea), or 27 to 29.9 kg/m2 with at least one comorbid condition.
- Ability to complete a 1 year study
You may not qualify if:
- Pregnancy
- Diabetes mellitus (type I, II or other)
- History of symptomatic 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: 23661689DERIVEDFidler MC, Sanchez M, Raether B, Weissman NJ, Smith SR, Shanahan WR, Anderson CM; BLOSSOM Clinical Trial Group. A one-year randomized trial of lorcaserin for weight loss in obese and overweight adults: the BLOSSOM trial. J Clin Endocrinol Metab. 2011 Oct;96(10):3067-77. doi: 10.1210/jc.2011-1256. Epub 2011 Jul 27.
PMID: 21795446DERIVED
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
January 16, 2008
First Posted
January 29, 2008
Study Start
January 1, 2008
Primary Completion
July 1, 2009
Study Completion
August 1, 2009
Last Updated
October 4, 2019
Results First Posted
February 7, 2013
Record last verified: 2019-08