Skip to main content
OpenTrials
Completed

NCT Number: NCT03946592

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Submental Fat

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chung-ang university hospital

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

normal saline

Drug

Inject the Drug into submental fat via subcutaneous

DWJ211

Drug

Inject the Drug into submental fat via subcutaneous

Primary outcomes

  1. PA-SMFRS, SA-SMFRS

    Time frame: 12 week after last treatment

    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

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

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

Acronym: SMF

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 10, 2019
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.