NCT01096979已完成2 期
A Double-Masked, Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal 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
- 60
- 主要终点
- Waist circumference
研究概览
简要总结
This is a double-masked evaluation of the safety and efficacy of LIPO-102 for the reduction of subcutaneous 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non pregnant female
- •Good general health
- •Sufficient abdominal fat for injections
- •Signed informed consent
- •BMI greater than or equal to 18 and less than 28 kg/m2
- •History of stable weight in past 3 months
排除标准
- •Known hypersensitivity to study drugs
- •Treatment with an investigational agent within 30 days of first dose
研究组 & 干预措施
LIPO-102, High
Experimental
LIPO-102, High
干预措施: LIPO-102 (Drug)
LIPO-102, Low
Experimental
LIPO-102, Low
干预措施: LIPO-102 (Drug)
Placebo
Experimental
Pbo
干预措施: Placebo (Drug)
结局指标
主要结局
Waist circumference
时间窗: 8 weeks
Reduction in abdominal adiposity
时间窗: 8 weeks
Safety
时间窗: 8 weeks
Vital signs, injection site assessment, clinical laboratory tests (hematology, serum chemistry, lipid panel including FFA, and urine dipstick analysis) and adverse events.
次要结局
- Photographic assessments(8 weeks)
- Skin-fold caliper measurements(8 weeks)
- Patient and clinician global impression of change questions(8 weeks)
- Patient and clinician Global Impression of severity survey(8 weeks)
- Abdominal appearance questionnaire(8 weeks)
研究者
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