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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03946592

Recruitment Status Recruiting

First Posted May 10, 2019

Last update posted May 16, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Submental Fat
  • Intervention/Treatment: Drug: Normal saline
    Drug: DWJ211
  • Phase: Phase 3
Detailed Description

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

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 150 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment
  • Official 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
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: June 2020
  • Estimated Study Completion Date: June 2020
Arms and interventions
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
Outcome Measures
  • Primary Outcome Measures: 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
Eligibility Criteria
  • Ages Eligible for Study: 19 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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.

Contacts and Locations
Contacts

Contact: MIJUNG SONG +82-2-550-8368 mjsong257@daewoong.co.kr

Locations

Korea, Republic of
Chung-ang university hospital
Seoul

Sponsors and Collaborators

Daewoong Pharmaceutical Co. LTD.

More Information
  • Responsible Party: Daewoong Pharmaceutical Co. LTD.
  • ClinicalTrials.gov Identifier: NCT03946592 History of Changes
  • Other Study ID Numbers: DW_DWJ211301
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: May 16, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No