NCT00479492已完成2 期
A 12-Week, Randomized, Subject And Investigator Blind, Placebo-Controlled Trial To Evaluate The Effect Of CP-866,087 On Weight Loss In Obese, Otherwise Healthy Adult 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
- Pfizer
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Measure the effect of weight loss over 12 weeks in overweight otherwise healthy patients. Measurements will include body weight and waist circumference. Measurements will occur at Day 1, 7, 14, 28, 42, 56, 70, 84 and 94.
研究概览
简要总结
The purpose of this study is to determine whether CP-866,087 is effective in the weight loss of overweight patients.
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
- 否
入选标准
- •Body Mass Index (BMI) 30 to 40 kg/m2 and total body weight of >110 lbs.
- •Otherwise healthy
排除标准
- •Women must be of non-childbearing potential.
- •Significant current or history of medical illness.
研究组 & 干预措施
1
Experimental
干预措施: CP-866,087 (Drug)
2
Experimental
干预措施: CP-866,087 (Drug)
3
Experimental
干预措施: CP-866,087 (Drug)
4
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Measure the effect of weight loss over 12 weeks in overweight otherwise healthy patients. Measurements will include body weight and waist circumference. Measurements will occur at Day 1, 7, 14, 28, 42, 56, 70, 84 and 94.
时间窗: 94 days
次要结局
- To characterize the effect of 4 weeks of dosing of 3 different doses of CP-866,087 on 24-hour urinary cortisol levels. Measured at Day 1 and Day 29(29 days)
- Exploratory biomarkers measured at Day 1, 14, 28, 56, and 84.(84 days)
- Waist circumference measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94.(94 days)
- To explore changes in pharmacodynamics (PD) markers of efficacy resulting from multiple PO doses of CP-866,087, including waist circumference, and serum lipids and exploratory biomarkers.(94 days)
- Serum Lipids measured at Day 1, 7, 14, 28, 56, 84 and 94.(94 days)
- To explore the effects of chronic, 12-week dosing with CP-866,087 on neuroendocrine endpoints, including testosterone, TSH, T4, and IGF1. Measured at Day 1, 28, 84 and 94.(94 days)
研究者
研究点 (1)
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