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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4,008
Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
Matching placebo tablet each morning and evening for a duration of 52 weeks.
Arena Pharmaceuticals, Inc.
San Diego, California, United States
Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52
The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.
Time frame: Baseline and Week 52
Percent Change in Body Weight From Baseline to Week 52
The percent change in body weight (kg) from baseline to week 52.
Time frame: Baseline and Week 52
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