Double-Blind, Randomized, Placebo-Controlled, 12-Week Study of the Safety and Efficacy of ATHX-105 Phosphate for the Treatment of Obesity
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
- 否
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
干预措施: Placebo (Drug)
2
干预措施: ATHX-105 phosphate (Drug)
3
干预措施: ATHX-105 phosphate (Drug)
4
干预措施: ATHX-105 phosphate (Drug)
5
干预措施: ATHX-105 phosphate (Drug)
6
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)
