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临床试验/NCT00735683
NCT00735683撤回2 期

Double-Blind, Randomized, Placebo-Controlled, 12-Week Study of the Safety and Efficacy of ATHX-105 Phosphate for the Treatment of Obesity

Healios K.K.0 个研究点开始时间: 2008年9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
撤回
发起方
Healios K.K.
主要终点
Change in body weight

研究概览

简要总结

This primary purpose of this study is to determine if ATHX-105 phosphate causes weight loss over a 12-week period.

详细描述

The rate of obesity in adults continues to increase. Obesity affects overall health and is associated with an increased risk for diabetes, high blood pressure, coronary artery disease, osteoarthritis, and sleep apnea. To date, the medication options to treat obesity have been limited.

This study will examine if a new investigational drug, ATHX-105 phosphate, may cause weight loss in humans over a 12-week 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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Obese adults with a body mass index of 30-45 kg/m2

排除标准

  • Pregnancy
  • Adults with serious or unstable current or past medical conditions

研究组 & 干预措施

1

Placebo Comparator

干预措施: Placebo (Drug)

2

Experimental

干预措施: ATHX-105 phosphate (Drug)

3

Experimental

干预措施: ATHX-105 phosphate (Drug)

4

Experimental

干预措施: ATHX-105 phosphate (Drug)

5

Experimental

干预措施: ATHX-105 phosphate (Drug)

6

Experimental

干预措施: ATHX-105 phosphate (Drug)

结局指标

主要结局

Change in body weight

时间窗: 12 weeks

次要结局

  • vital signs, lipids/glucose, waist circumference(12 weeks)

研究者

发起方
Healios K.K.
申办方类型
Industry

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