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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
3,182
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks.
Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks.
Arena Pharmaceuticals, Inc.
San Diego, California, United States
Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52
The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1. Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1.
Time frame: 52 weeks
Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104
The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1 and who maintained this reduction during year 2.
Time frame: 104 weeks
Year 1: Percent Change in Body Weight From Baseline to Week 52
Year 1: The % change in body weight (kg) from baseline to week 52.
Time frame: 52 weeks
Year 2: Percent Change in Body Weight From Week 52 to Week 104
Year 2: The % change in body weight (kg) from week 52 to week 104.
Time frame: 52 weeks
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