BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management
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|ClinicalTrials.gov Identifier: NCT00395135|
Recruitment Status : Completed
First Posted : November 2, 2006
Results First Posted : February 7, 2013
Last Update Posted : October 2, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Obesity||Drug: Lorcaserin 10 mg BID Drug: Matching Placebo BID||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3182 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management; A 104-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Obese Patients|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
Experimental: Lorcaserin 10 mg BID
Lorcaserin 10 mg tablet each morning and evening
Drug: Lorcaserin 10 mg BID
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks.
Other Name: APD356
Placebo Comparator: Matching Placebo BID
Matching placebo tablet each morning and evening
Drug: Matching Placebo BID
Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks.
- Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 [ Time Frame: 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.
- Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104 [ Time Frame: 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.
- Year 1: Percent Change in Body Weight From Baseline to Week 52 [ Time Frame: 52 weeks ]Year 1: The % change in body weight (kg) from baseline to week 52.
- Year 2: Percent Change in Body Weight From Week 52 to Week 104 [ Time Frame: 52 weeks ]Year 2: The % change in body weight (kg) from week 52 to week 104.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- History of heart valve disease
- Serious or unstable current or past medical conditions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395135
|United States, California|
|Arena Pharmaceuticals, Inc.|
|San Diego, California, United States, 92121|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Eisai Inc.|
|Other Study ID Numbers:||
|First Posted:||November 2, 2006 Key Record Dates|
|Results First Posted:||February 7, 2013|
|Last Update Posted:||October 2, 2019|
|Last Verified:||January 2013|