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

Phase 2

Completed

• Conditions: Treatment for Submental Fat
• Interventions: Drug: Normal saline; Drug: DWJ211

• Registration Number: NCT03224117
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat

Detailed Description

DWJ211

_ reduction of moderate or severe submental fat

Study Timeline

• Study First Submitted: 2017-07-19
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Study Start: 2017-10-26
• Primary Completion: 2018-06-29
• Study Completion: 2018-06-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. 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.
2. Dissatisfaction with the submental area expressed by the subject as a rating of 1~3 using the SSS as determinded on Visit 1.
3. less than 35kg/m2 in body mass index on Visit1.
4. subject who will agree with the no treatment for the procedure that may affect to reduction or the submental fat.
5. subject who will agree with maintaining their body weight.

Exclusion Criteria

1. History of any intervention to treat SMF
2. 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.
3. Evidence of any cause of enlargement in the submental area.
4. history or current symptoms of dysphagia.
5. a result on coagulation tests that indicates the presence of any clinically significant bleeding disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Normal saline	SQ injection
DWJ211_0.5%	DWJ211	SQ injection with DWJ211 0.5%
DWJ211_1%	DWJ211	SQ injection with DWJ211 1.0%
DWJ211_2%	DWJ211	SQ injection with DWJ211 2.0%

Primary Outcome Measures

Name	Time	Method
2-grade response : PA-SMFRS	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	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	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	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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Chung-ang university hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul Asan medical center; 🇰🇷 Seoul, Korea, Republic of

Konkuk university medical center; 🇰🇷 Seoul, Korea, Republic of