NCT00485017已完成2 期
A Phase II Randomized, Double-Blind, Double-Dummy, Parallel Group, Placebo Controlled Study of THR-4109 in Obese Subjects
Theracos20 个研究点 分布在 2 个国家目标入组 220 人开始时间: 2007年8月最近更新:
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
- 入组人数
- 220
- 试验地点
- 20
- 主要终点
- Percent change from baseline weight
研究概览
简要总结
The purpose of this study is to evaluate the safety and effect of THR-4109 on weight loss in obese subjects over a 24-week treatment period.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30 to 60 years of age
- •Body mass index between 30 and 40 kg/m2
- •Women of child bearing potential with a negative pregnancy test prior to entry and who agree to use an acceptable method of contraception throughout the study
- •Able and willing to give written informed consent
排除标准
- •Weight loss of more than 3 kg in the previous 3 months
- •Current or previous use (within 3 months) of medications that influence weight
- •Known endocrine origin for obesity, such as hypothyroidism and Cushing's syndrome
- •Current or history of eating disorder such as bulimia, anorexia nervosa, binge eating or laxative abuse
- •Current serious/unstable medical condition
- •Current pharmacologically treated diabetes or fasting plasma glucose ≥ 126 mg/dL
研究组 & 干预措施
1
Experimental
THR-4109: 115 mg orally in am, 115 mg orally in pm for 24 weeks
干预措施: THR-4109 (Drug)
2
Experimental
THR-4109: 100 mg orally in am, 100 mg orally in pm for 24 weeks
干预措施: THR-4109 (Drug)
3
Experimental
THR-4109: 15 mg orally in am, 15 mg orally in pm for 24 weeks
干预措施: THR-4109 (Drug)
4
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change from baseline weight
时间窗: 24 weeks
次要结局
- Proportion of subjects who achieve weight loss of at least 5% and at least 10% of baseline body weight(24 weeks)
- Serum lipids, waist circumference, fasting plasma glucose and blood pressure(24 weeks)
- Safety and tolerability of THR-4109(24 weeks)
研究者
研究点 (20)
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