A Randomized, Double-blind, Multi-center, Placebo-controlled, Dose Finding Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 3
- 主要终点
- 2-grade response : PA-SMFRS
研究概览
简要总结
evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat
详细描述
DWJ211
_ reduction of moderate or 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
- Quadruple (Participant, Care Provider, 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
- 是
入选标准
- •submental fat grade by the investigator as 2 or 3 using the PA-SMFRS and graded by the subject as 2 or 3 using the SA-SMFRS as determined on Visit
- •Dissatisfaction with the submental area expressed by the subject as a rating of 1~3 using the SSS as determinded on Visit
- •less than 35kg/m2 in body mass index on Visit
- •subject who will agree with the no treatment for the procedure that may affect to reduction or the submental fat.
- •subject who will agree with maintaining their body weight.
排除标准
- •History of any intervention to treat SMF
- •History of trauma associated with the chin or neck areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment.
- •Evidence of any cause of enlargement in the submental area.
- •history or current symptoms of dysphagia.
- •a result on coagulation tests that indicates the presence of any clinically significant bleeding disorder.
研究组 & 干预措施
Placebo
SQ injection
干预措施: Normal saline (Drug)
DWJ211_0.5%
SQ injection with DWJ211 0.5%
干预措施: DWJ211 (Drug)
DWJ211_1%
SQ injection with DWJ211 1.0%
干预措施: DWJ211 (Drug)
DWJ211_2%
SQ injection with DWJ211 2.0%
干预措施: DWJ211 (Drug)
结局指标
主要结局
2-grade response : PA-SMFRS
时间窗: 4 week after last treatment
proportion of subject who simultaneously have at least a 2 grade improvement from baseline on the PA-SMFRS at 4weeks after the last treatment
2-grade response : SA-SMFRS
时间窗: 4 week after last treatment
proportion of subject who simultaneously have at least a 2-grade improvement from baseline on the SA-SMFRS at 4weeks after the last treatment
1-grade response : PA-SMFRS
时间窗: 4 week after last treatment
proportion of subject who simultaneously have at least a 1-grade improvement from baseline on the PA-SMFRS at 4weeks after the last treatment
1-grade response : SA-SMFRS
时间窗: 4 week after last treatment
proportion of subject who simultaneously have at least a 1-grade improvement from baseline on the SA-SMFRS at 4weeks after the last treatment
次要结局
- MRI volume response rate(4 week after last treatment)
- improvement: SA-SMFIS(4 week after last treatment)
- thickness response rate : caliper(4 week after last treatment)
- obtained 5 score : SSS(4 week after last treatment)