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

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ClinicalTrials.gov Identifier: NCT03224117
Recruitment Status : Unknown
Verified October 2017 by Daewoong Pharmaceutical Co. LTD..
Recruitment status was:  Active, not recruiting
First Posted : July 21, 2017
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Study Description
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Brief Summary:
evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat

Condition or disease Intervention/treatment Phase
Treatment for Submental Fat Drug: DWJ211 Drug: Normal saline Phase 2

Detailed Description:

DWJ211

_ reduction of moderate or severe submental fat

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 26, 2017
Estimated Primary Completion Date : June 29, 2018
Estimated Study Completion Date : June 29, 2018
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224117


Locations
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Korea, Republic of
Chung-ang university hospital
Seoul, Korea, Republic of
Konkuk university medical center
Seoul, Korea, Republic of
Seoul Asan medical center
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
Investigators
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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
More Information
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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT03224117    
Other Study ID Numbers: DW_DWJ211001
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No