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Completed

NCT Number: NCT03224117

Clinicial 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

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Key information

Conditions

Treatment for Submental Fat

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chung-ang university hospital, Seoul, South Korea

Loading trial locations.

About this study

DWJ211

_ reduction of moderate or severe submental fat

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.
  • 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.

Treatment and study plan

DWJ211

Drug

inject the Drug into submental fat via subcutaneous

normal saline

Drug

inject the Drug into submental fat via subcutaneous

Primary outcomes

  1. 2-grade response : PA-SMFRS

    Time frame: 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. 2-grade response : SA-SMFRS

    Time frame: 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

  3. 1-grade response : PA-SMFRS

    Time frame: 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

  4. 1-grade response : SA-SMFRS

    Time frame: 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 outcomes

  1. MRI volume response rate

    Time frame: 4 week after last treatment

    change rate of reduction in SMF volume

  2. improvement: SA-SMFIS

    Time frame: 4 week after last treatment

    improvement in the Subject reported submental fat impact scale overall score

  3. obtained 5 score : SSS

    Time frame: 4 week after last treatment

    proportion of subjects who have more than 5 score on the SSS(somewhat satisfied)

  4. thickness response rate : caliper

    Time frame: 4 week after last treatment

    change rate of reduction in SMF volume

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

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

Acronym: SMF

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2017
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.