NCT00785408已完成2 期
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Examine the Safety, Tolerability, and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight 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
- 273
- 试验地点
- 1
- 主要终点
- To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects
研究概览
简要总结
A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to examine the safety, tolerability, and effect on body weight of subcutaneous AC2307 in obese or overweight 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 (Participant, Investigator)
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
- •Is obese with a body mass index (BMI) ≥30 kg/m^2 to ≤45 kg/m^2, or is overweight with a BMI ≥27 kg/m^2 to <30 kg/m^2 and has at least one weight-related comorbidity (dyslipidemia, impaired fasting glucose, hypertension, obstructive sleep apnea syndrome, polycystic ovary syndrome, and/or osteoarthritis)
排除标准
- •Has had a major change in daily physical activity (e.g., initiation of an exercise program) or has been enrolled in a weight loss program within 2 months prior to study start
- •Has received AC2307 or pramlintide in a clinical study or has received prior treatment with pramlintide (SYMLIN®) or calcitonin
- •Has received any investigational drug within 1 month or within a period corresponding to five times the half-life of the investigational drug, whichever is greater, before study start
- •Has donated blood within 2 months before study start or is planning to donate blood during the study
研究组 & 干预措施
1
Experimental
干预措施: AC2307 (Drug)
2
Experimental
干预措施: AC2307 (Drug)
3
Experimental
干预措施: AC2307 (Drug)
4
Placebo Comparator
干预措施: placebo (Drug)
5
Placebo Comparator
干预措施: placebo (Drug)
6
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects
时间窗: 24 weeks
To assess the safety and tolerability of AC2307 injected SC BID in obese or overweight subjects
时间窗: 24 weeks
次要结局
- To examine the effect of AC2307 injected SC BID in obese or overweight subjects on the following parameters: waist circumference; gastric emptying rate; fasting circulating metabolic parameters; patient reported outcomes(24 weeks)
- To examine the pharmacokinetics of AC2307 injected SC BID in obese or overweight subjects(24 weeks)
研究者
研究点 (1)
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