BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395135
• Other study ID #: APD356-009
• Status: Completed
• Phase: Phase 3
• Start date: November 2006
• Est. completion date: February 2009

Study information

• Verified date: January 2013
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3182
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Lorcaserin 10 mg BID
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks.
• Matching Placebo BID
Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks.

Locations

Country	Name	City	State
United States	Arena Pharmaceuticals, Inc.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52	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.	52 weeks
Primary	Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104	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.	104 weeks
Secondary	Year 1: Percent Change in Body Weight From Baseline to Week 52	Year 1: The % change in body weight (kg) from baseline to week 52.	52 weeks
Secondary	Year 2: Percent Change in Body Weight From Week 52 to Week 104	Year 2: The % change in body weight (kg) from week 52 to week 104.	52 weeks

External Links

•   Arena Pharmaceuticals, Inc. Home Page