Clinicial Trial to Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat

Study Overview
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Brief Summary
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evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat

Detailed Description
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DWJ211 _ reduction of moderate or severe submental fat

Official Title
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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

Conditions
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Treatment for Submental Fat

Intervention / Treatment
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* Drug: DWJ211
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 1. Dissatisfaction with the submental area expressed by the subject as a rating of 1 3 using the SSS as determinded on Visit 1. less than 35kg/m2 in body mass index on Visit1. 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>SQ injection | Drug: Normal saline<br>* inject the Drug into submental fat via subcutaneous<br>|
| Experimental: DWJ211_0.5%<br>SQ injection with DWJ211 0.5% | Drug: DWJ211<br>* inject the Drug into submental fat via subcutaneous<br>|
| Experimental: DWJ211_1%<br>SQ injection with DWJ211 1.0% | Drug: DWJ211<br>* inject the Drug into submental fat via subcutaneous<br>|
| Experimental: DWJ211_2%<br>SQ injection with DWJ211 2.0% | Drug: DWJ211<br>* inject the Drug into submental fat via subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-grade response : PA-SMFRS | proportion of subject who simultaneously have at least a 2 grade improvement from baseline on the PA-SMFRS at 4weeks after the last treatment | 4 week after last treatment | 
| 2-grade response : SA-SMFRS | proportion of subject who simultaneously have at least a 2-grade improvement from baseline on the SA-SMFRS at 4weeks after the last treatment | 4 week after last treatment | 
| 1-grade response : PA-SMFRS | proportion of subject who simultaneously have at least a 1-grade improvement from baseline on the PA-SMFRS at 4weeks after the last treatment | 4 week after last treatment | 
| 1-grade response : SA-SMFRS | proportion of subject who simultaneously have at least a 1-grade improvement from baseline on the SA-SMFRS at 4weeks after the last treatment | 4 week after last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI volume response rate | change rate of reduction in SMF volume | 4 week after last treatment | 
| improvement: SA-SMFIS | improvement in the Subject reported submental fat impact scale overall score | 4 week after last treatment | 
| obtained 5 score : SSS | proportion of subjects who have more than 5 score on the SSS(somewhat satisfied) | 4 week after last treatment | 
| thickness response rate : caliper | change rate of reduction in SMF volume | 4 week after last treatment |