NCT01540864终止2 期
A 26 Week Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety and Efficacy of Various Doses of HPP404 on Weight Loss in Overweight or Obese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 126
- 试验地点
- 10
- 主要终点
- Percent weight loss
研究概览
简要总结
The purpose of this study is to compare the safety and effect of HPP404 versus placebo on body weight in overweight or obese subjects.
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
- •Body Mass Index (BMI) from 30.0 to 39.9 kg/m2, for subjects with no additional co morbidities;
- •BMI from 27 to 39.9 kg/m2, for subjects with co morbidities (i.e. dyslipidemia defined as high LDL (≥ 160 mg/dL) or high total cholesterol (≥ 240 mg/dL), or subjects with hypertension)
排除标准
- •Systolic blood pressure > 160 mmHg and/or diastolic pressure > 90 mmHg at the Screening Visit without treatment
- •History of use of tobacco or nicotine-containing products 180 days prior to Screening visit
- •Subjects with type 2 diabetes or fasting blood glucose concentration ≥ 126 mg/dL
- •History of appetite or weight modifying surgeries/procedures
研究组 & 干预措施
HPP404 35 mg
Experimental
干预措施: HPP404 (Drug)
HPP404 50 mg
Experimental
干预措施: HPP404 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent weight loss
时间窗: Day 1 to Day 182
次要结局
- Absolute and percent change in Body Mass Index (BMI)(Day 1 to Day 182)
- Number of subjects attaining a 5% or more weight loss(Day 1 to Day 182)
研究者
研究点 (10)
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