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

A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase Ⅲ 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: Submental Fat
• Intervention / Treatment: Drug: Normal saline; Drug: DWJ211

Detailed Description

DWJ211 is a injectable drug for improvement in the appearance of moderate to severe submental fat (SMF)

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital

Participation Criteria

Eligibility Criteria

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

Description

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.

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; Inject the Drug into submental fat via subcutaneous	Drug: Normal saline; Inject the Drug into submental fat via subcutaneous
Experimental: DWJ211 group; Inject the Drug into submental fat via subcutaneous	Drug: DWJ211; Inject the Drug into submental fat via subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PA-SMFRS, SA-SMFRS	Proportion of subject who simultaneously have at least a 1 grade, 2grade improvement from baseline on the PA-SMFRS, SA-SMFRS after the last treatment	12 week after last treatment

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): July 2, 2020
• Study Completion (Actual): July 2, 2020

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 10, 2019

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_DWJ211301

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