Clinical trial NCT00395135: BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: Obesity
Weight loss
lorcaserin
APD356
BLOOM
Hypertension
Dyslipidemia
Sleep apnea
glucose tolerance
cardiovascular disease
Arena
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2006-11-02
Enrollment: 3182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Diabetes
* Pregnancy
* History of heart valve disease
* Serious or unstable current or past medical conditions

Primary outcomes:
measure: Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52
timeFrame: 52 weeks
measure: Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104
timeFrame: 104 weeks
Secondary outcomes:
measure: Year 1: Percent Change in Body Weight From Baseline to Week 52
timeFrame: 52 weeks
measure: Year 2: Percent Change in Body Weight From Week 52 to Week 104
timeFrame: 52 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Arena Pharmaceuticals, Inc.
state: California
Study officials:
References:
citation: 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.
citation: Handelsman 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.
citation: Nguyen 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.
citation: Nesto 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.
citation: Weissman 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.
citation: Smith 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.