A Randomized, Double-blind, Placebo-controlled, Dose Ranging, Parallel, Multi-center, Phase II Study to Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Responder rate of 2-grade improvement in CA-SMFRS
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled, dose-ranging, parallel, multi-center, phase II study to evaluate the efficacy and safety of MT921 in subjects with moderate to severe submental fat.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects over 19 and under 65 years old
- •Subjects achieving CA-SMFRS and PA-SMFRS score of 2 or 3
- •Subjects who voluntarily signed the Informed Consent
排除标准
- •Subjects who had liposuction or other procedures on the treatment area that might affect the assessment.
- •Subjects with BMI over 35.0kg/m^2
- •Subjects with dysphagia
- •Subjects who are allergic or hypersensitive to the investigational product
- •Subjects who are pregnant or lactating, or does not agree to use an accepatble form of contraception during the clinical trial.
- •Subjects who are otherwise deemed uneligible by the investigator.
研究组 & 干预措施
MT921
1% or 1.5%, subcutaneously administered at most 50 injections per treatment.
干预措施: MT921 (Drug)
Placebo
Subcutaneously administered at most 50 injections per treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Responder rate of 2-grade improvement in CA-SMFRS
时间窗: 4 weeks after the last treatment session
Proportion of subjects who have at least a 2-grade improvement from basleine on the Clinician Assessed-SubMental Fat Rating Scale (5-point scale, 0-No submental fat to 4-Excessive submental fat) at 4 weeks after the last treatment.
Responder rate of 2-grade improvement in PA-SMFRS
时间窗: 4 weeks after the last treatment session
Proportion of subjects who have at least a 2-grade improvement from basleine on the Patient Assessed-SubMental Fat Rating Scale (5-point scale, 0-No submental fat to 4-Excessive submental fat) at 4 weeks after the last treatment.
Responder rate of 1-grade improvement in CA-SMFRS
时间窗: 4 weeks after the last treatment session
Proportion of subjects who have at least a 1-grade improvement from basleine on the Clinician Assessed-SubMental Fat Rating Scale (5-point scale, 0-No submental fat to 4-Excessive submental fat) at 4 weeks after the last treatment.
Responder rate of 1-grade improvement in PA-SMFRS
时间窗: 4 weeks after the last treatment session
Proportion of subjects who have at least a 1-grade improvement from basleine on the Patient Assessed-SubMental Fat Rating Scale (5-point scale, 0-No submental fat to 4-Excessive submental fat) at 4 weeks after the last treatment.
次要结局
未报告次要终点