BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management; A 104-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Obese Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 3,182
- 试验地点
- 1
- 主要终点
- Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese adults with a BMI 30 to 45 kg/m2 or overweight adults with a BMI 27 to 29.9 kg/m2 and at least one obesity-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, glucose intolerance, sleep apnea)
- •Ability to complete a 2 year study
排除标准
- •Pregnancy
- •History of heart valve disease
- •Serious or unstable current or past medical conditions
研究组 & 干预措施
Lorcaserin 10 mg BID
Lorcaserin 10 mg tablet each morning and evening
干预措施: Lorcaserin 10 mg BID (Drug)
Matching Placebo BID
Matching placebo tablet each morning and evening
干预措施: Matching Placebo BID (Drug)
结局指标
主要结局
Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52
时间窗: 52 weeks
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.
Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104
时间窗: 104 weeks
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.
次要结局
- Year 1: Percent Change in Body Weight From Baseline to Week 52(52 weeks)
- Year 2: Percent Change in Body Weight From Week 52 to Week 104(52 weeks)