NCT00395135

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

Completed Phase 3 Results posted Last updated 19 September 2019

What this trial tests

Phase 3 trial testing Lorcaserin 10 mg BID in Obesity in 3,182 participants. Completed in 1 February 2009.

Timeline

1 November 2006

Primary endpoint
1 February 2009

1 February 2009

Quick facts

Lead sponsor	Eisai Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	3,182
Start date	1 November 2006
Primary completion	1 February 2009
Estimated completion	1 February 2009
Sites	1 location across United States

Drugs / interventions tested

• Lorcaserin 10 mg BID — full drug profile →
• Matching Placebo BID — full drug profile →

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Eisai Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Multicenter, placebo-controlled trial of lorcaserin for weight management.
   Smith SR, Weissman NJ, Anderson CM, Sanchez M, et al · · 2010 · cited 603× · PMID 20647200 · DOI 10.1056/nejmoa0909809
2. Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials.
   Weissman NJ, Sanchez M, Koch GG, Smith SR, et al · · 2013 · cited 46× · PMID 23661689 · DOI 10.1161/circimaging.112.000128
3. Evaluation of lorcaserin on progression of prediabetes to type 2 diabetes and reversion to euglycemia.
   Nesto R, Fain R, Li Y, Shanahan W. · · 2016 · cited 18× · PMID 27116910 · DOI 10.1080/00325481.2016.1178590
4. Abstracts from the 38th annual meeting of the society of general internal medicine.
   · 2015 · cited 14× · PMID 25869016 · DOI 10.1007/s11606-015-3271-0
5. Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials.
   Weissman NJ, Smith SR, Fain R, Hall N, et al · · 2017 · cited 10× · PMID 27888609 · DOI 10.1002/oby.21695
6. Lorcaserin in Obese and Overweight Patients Taking Prohibited Serotonergic Agents: A Retrospective Analysis.
   Nguyen CT, Zhou S, Shanahan W, Fain R. · · 2016 · cited 8× · PMID 27206567 · DOI 10.1016/j.clinthera.2016.04.004
7. Discrepancies in the Registries of Diet vs Drug Trials.
   Ludwig DS, Ebbeling CB, Heymsfield SB. · · 2019 · cited 5× · PMID 31722021 · DOI 10.1001/jamanetworkopen.2019.15360
8. Medicines for Obesity: Appraisal of Clinical Studies with Grading of Recommendations, Assessment, Development, and Evaluation Tool.
   Karavia EA, Giannopoulou PC, Konstantinopoulou V, Athanasopoulou K, et al · · 2023 · cited 3× · PMID 36771314 · DOI 10.3390/nu15030606