NCT00297180已完成2 期
A Double-Blind, Randomized, Placebo-controlled Study to Evaluate Weight Loss, Safety, Tolerability and Pharmacokinetics in Obese Subjects Following 12-Week Dosing of GW869682, an SGLT2 Inhibitor
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 3
- 主要终点
- Percentage change in body weight from baseline to Week 12.
研究概览
简要总结
GW869682 causes glucose to be excreted in the urine. The purpose of this study is to see whether enough calories from glucose are excreted in the urine to cause weight loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a BMI within range 30.0 to 40.0kg/m2, inclusive.
- •Females who meet above criteria must be physiologically incapable of becoming pregnant (ie., surgically sterilized, or post-menopausal per protocol definition).
排除标准
- •History of eating disorders.
- •Recent history of weight loss or gain.
- •Had gastrointestinal surgery for treatment of obesity.
- •Type 1 or type 2 diabetes mellitus.
- •Have a positive urine drug screen.
- •Have liver disease.
- •Have hepatitis B, hepatitis C, or HIV antibodies.
- •Have a thyroid disorder that is not under control with medication.
- •Have any disease (such as heart, liver, blood, nervous system, or kidney disease, or cancer).
- •Are unable to participate in an exercise program.
- •Have used weight loss drugs within 3 months before the start of the study.
- •Are currently using warfarin, digoxin, oral anti-coagulants (other than aspirin and non-steroidal anti-inflammatory drugs), oral or injectable corticosteroids (inhaled & intranasal corticosteroids are permitted), or antiretroviral medications.
- •Used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
- •High or low blood pressure.
结局指标
主要结局
Percentage change in body weight from baseline to Week 12.
时间窗: from baseline to Week 12.
次要结局
- Blood levels of GW869682 at the Week 2 and Week 11.(at the Week 2 and Week 11)
研究者
研究点 (3)
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