NCT00395135

BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,182 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Lorcaserin 10 mg BID	Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks.
DRUG	Matching Placebo BID	Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks.

Timeline

• Start date: 2006-11-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2006-11-02
• Last updated: 2019-10-02
• Results posted: 2013-02-07

Locations

1 site across 1 country: United States