NCT02568319已完成2 期
A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging in a Defined Special Population - Obese Subjects (BMI > or Equal to 30 kg/m2)
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
- 120
- 试验地点
- 6
- 主要终点
- Safety as measured by physical examination, adverse events, vital signs, and laboratory tests.
研究概览
简要总结
This is a multi-center, randomized, placebo-controlled, double-blind study evaluating the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging in 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male or non-pregnant female subjects
- •Capable of providing written consent
- •BMI > 30 kg/m2 but < 40 kg/m2
- •Stable diet and exercise routine
- •At least "Slightly Dissatisfied" with their abdominal bulging on the Abdominal Contour Questionnaire (ACQ)
排除标准
- •BMI > 40 kg/m2
- •Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen.
- •Plan on starting a weight loss or exercise program during the study
- •Known hypersensitivity to study drugs
- •Have any medical condition that might complicate study procedures
研究组 & 干预措施
LIPO-202
Experimental
Experimental arm
干预措施: LIPO-202 (Drug)
Placebo
Placebo Comparator
Placebo comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety as measured by physical examination, adverse events, vital signs, and laboratory tests.
时间窗: 9 weeks
Physical examination, adverse events, vital signs, and laboratory tests.
次要结局
- Change in waist circumference.(9 weeks)
研究者
研究点 (6)
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