BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management

Eisai

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Drug: Lorcaserin 10 mg twice a day (BID); Drug: Matching Placebo; Drug: Lorcaserin 10 mg once daily (QD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00603902

APD356-011

Details and patient eligibility

About

The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients.

Full description

Randomized, double-blind, placebo-controlled, parallel-group assessment of the effects of lorcaserin hydrochloride during 52 weeks of administration to overweight or obese male and female volunteers aged 18 to 65 years inclusive.

Enrollment: 4,008 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Overweight and/or obese men and women with a body mass index (BMI) 30 to 45 kg/m2 with or without a comorbid condition (e.g., hypertension, dyslipidemia, CV disease, glucose intolerance, sleep apnea), or 27 to 29.9 kg/m2 with at least one comorbid condition.
• Ability to complete a 1 year study

Exclusion criteria

• Pregnancy
• Diabetes mellitus (type I, II or other)
• History of symptomatic 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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4,008 participants in 3 patient groups, including a placebo group

Lorcaserin 10 mg QD

Experimental group

Description:

Lorcaserin 10 mg tablet each morning and placebo tablet each evening

Treatment:

Drug: Lorcaserin 10 mg once daily (QD)

Lorcaserin 10 mg BID

Experimental group

Description:

Lorcaserin 10 mg tablet each morning and evening

Treatment:

Drug: Lorcaserin 10 mg twice a day (BID)

Matching Placebo

Placebo Comparator group

Description:

Matching placebo tablet each morning and evening

Treatment:

Drug: Matching Placebo