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

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

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

Study Overview

• Status: Completed
• Conditions: Treatment for Submental Fat
• Intervention / Treatment: Drug: Normal saline; Drug: DWJ211

Detailed Description

DWJ211

_ reduction of moderate or severe submental fat

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of
    • Seoul ASAN Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Study Chair: Beom Joon Kim, MD, PhD, Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Principal Investigator: Yang-won Lee, MD, PhD, Konkuk University Medical Center; Principal Investigator: Chong-hyun Won, MD, PhD, Seoul ASAN Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2017
• Primary Completion (Actual): June 29, 2018
• Study Completion (Actual): June 29, 2018

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWJ211001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No