NCT00112021已完成2 期
A Phase 2B, Randomized, Double-Blinded, Placebo-Controlled, Dose Ranging, Multicenter Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- To examine the safety and tolerability of pramlintide in obese subjects
研究概览
简要总结
This is a study to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is obese with a body mass index (BMI) >=30 kg/m^2 to <=50 kg/m^2, and has been obese for at least one year before screening.
- •Usually consumes at least three major meals (morning, midday, and evening) each day.
排除标准
- •Is currently enrolled in a formal weight-loss program.
- •Has had liposuction within 1 year before screening or is planning to have liposuction during the study.
- •Has received any investigational drug within 3 months before screening.
- •Has previously participated in a study using pramlintide.
研究组 & 干预措施
Pramlintide Acetate
Experimental
干预措施: pramlintide acetate (Drug)
结局指标
主要结局
To examine the safety and tolerability of pramlintide in obese subjects
时间窗: Approximately 16 weeks
To examine the effect of pramlintide on body weight in obese subjects
时间窗: Approximately 16 weeks
次要结局
- To investigate the effect of pramlintide in obese subjects on anthropometric and fasting/postprandial humoral metabolic parameters(Approximately 16 weeks)
研究者
研究点 (1)
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