Overview

BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
0
Participant gender:
All
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)
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Arena Pharmaceuticals
Eisai Inc.
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