Conditions: Obesity
Keywords: Obesity Weight loss lorcaserin APD356 BLOSSOM Hypertension Dyslipidemia Sleep apnea glucose tolerance cardiovascular disease Arena
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4008
Healthy volunteers: no

Brief summary:
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.

Detailed 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.

Arms:
arm 1: Lorcaserin 10 mg tablet each morning and placebo tablet each evening arm 2: Lorcaserin 10 mg tablet each morning and evening arm 3: Matching placebo tablet each morning and evening

Interventions: intervention 1: Lorcaserin 10 mg once daily (QD) intervention 2: Lorcaserin 10 mg twice a day (BID) intervention 3: Matching Placebo
Intervention descriptions: intervention 1: Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks. intervention 2: Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks. intervention 3: Matching placebo tablet each morning and evening for a duration of 52 weeks.

Protocol document: