A 12-Week, Dose-Ranging, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of APD356 in Obese Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Change in body weight
研究概览
简要总结
This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c receptor agonist, in clinical development as a potential treatment for obesity.
The purpose of this study is to obtain a preliminary assessment of the safety and efficacy of APD356, when administered daily for 12 weeks, in obese subjects who are otherwise healthy. Subjects who are on concomitant medications for control of hypertension or blood lipids may qualify.
详细描述
This is a double-blind, placebo-controlled, randomized, parallel group study. Three different doses of APD356 or placebo will be administered daily for 12 weeks, to obese, male and nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400 subjects will be enrolled.
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
- Double
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
- 是
入选标准
- •Healthy male or nonpregnant, nonlactating females aged 18-65 years (inclusive)
- •Body mass index (BMI) of 30-45 kg/m2
- •Non-smoker
- •No concomitant medications other than hypertension medications (stable > 90 days) and/or statins (stable > 90 days)
- •No past treatment with drugs associated with the development of pulmonary hypertension or cardiac valvular insufficiency
- •No more than mild mitral valve regurgitation and absence of aortic valve regurgitation upon screening echocardiogram
排除标准
- 未提供
结局指标
主要结局
Change in body weight
次要结局
- Changes in waist circumference, hip circumference, and waist/hip ratio
- Safety