NCT01180465已完成2 期
A Multi-center, Randomized, Double-masked, Placebo-controlled, Dose-ranging, Study of the Safety and Efficacy of Subcutaneous Injections of LIPO-102 Compared With Placebo for the Reduction of Abdominal Subcutaneous Adiposity
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 主要终点
- Safety
研究概览
简要总结
LIPO-102 is under evaluation for treatment of abdominal adiposity
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 - 50 years old inclusive
- •Localized area of abdominal subcutaneous adiposity of Grade 3 or above on the P-PNS or C-PNS
- •BMI < 25kg/m sq
- •Stable diet and exercise and body weight
排除标准
- •Prior treatment of abdominal subcutaneous adipose tissue
- •Females within 12 months postpardum
- •Known hypersensitivity to the drugs or components
研究组 & 干预措施
LIPO-102 High
Experimental
干预措施: LIPO-102 (Drug)
LIPO-102, Low
Experimental
干预措施: LIPO-102 Low (Drug)
LIPO-102; Placebo
Placebo Comparator
干预措施: LIPO-102, Placebo (Drug)
结局指标
主要结局
Safety
时间窗: 8 weeks treatment and 1 week follow up
physical exam, ECG, vital signs, clinical assessment is injection site, clinical laboratory tests, and adverse events
Change in abdominal circumference
时间窗: 8 weeks
abdominal circumference
次要结局
- Patient and clinician photo numeric scale(8 weeks)
- Patient global assessment of severity scale(8 weeks)
- Abdominal subcutaneous adiposity questionnaire(8 weeks)
- photographic assessment(8 weeks)
研究者
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