BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

Phase 3

Completed

• Conditions: Obesity
• Interventions: Drug: Lorcaserin 10 mg BID; Drug: Matching Placebo BID

• Registration Number: NCT00395135
• Lead Sponsor: Eisai Inc.

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-31
• Study First Submitted QC: 2006-10-31
• Study Start: 2006-11
• Study First Posted: 2006-11-02
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Disposition First Submitted: 2012-07-26
• Disposition First Submitted QC: 2012-08-06
• Disposition First Posted: 2012-08-14
• Status Verified: 2013-01
• Results First Submitted: 2013-01-04
• Results First Submitted QC: 2013-01-04
• Results First Posted: 2013-02-07
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3182

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lorcaserin 10 mg BID	Lorcaserin 10 mg BID	Lorcaserin 10 mg tablet each morning and evening
Matching Placebo BID	Matching Placebo BID	Matching placebo tablet each morning and evening

Primary Outcome Measures

Name	Time	Method
Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52	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	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.

Secondary Outcome Measures

Name	Time	Method
Year 1: Percent Change in Body Weight From Baseline to Week 52	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	52 weeks	Year 2: The % change in body weight (kg) from week 52 to week 104.

Trial Locations

Locations (1)

Arena Pharmaceuticals, Inc.; 🇺🇸 San Diego, California, United States