BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management

A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients

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.

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.

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