BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

Eisai

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Drug: Lorcaserin 10 mg BID; Drug: Matching Placebo BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT00395135

APD356-009

Details and patient eligibility

About

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)

Enrollment: 3,182 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,182 participants in 2 patient groups, including a placebo group

Lorcaserin 10 mg BID

Experimental group

Description:

Lorcaserin 10 mg tablet each morning and evening

Treatment:

Drug: Lorcaserin 10 mg BID

Matching Placebo BID

Placebo Comparator group

Description:

Matching placebo tablet each morning and evening

Treatment:

Drug: Matching Placebo BID