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

NCT ID: NCT03946592

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-15

Study Completion Date

2020-07-02

Brief Summary

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

Detailed Description

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

Conditions

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Submental Fat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo group

Inject the Drug into submental fat via subcutaneous

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Inject the Drug into submental fat via subcutaneous

DWJ211 group

Inject the Drug into submental fat via subcutaneous

Group Type EXPERIMENTAL

DWJ211

Intervention Type DRUG

Inject the Drug into submental fat via subcutaneous

Interventions

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Normal saline

Inject the Drug into submental fat via subcutaneous

Intervention Type DRUG

DWJ211

Inject the Drug into submental fat via subcutaneous

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chung-ang university hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW_DWJ211301

Identifier Type: -

Identifier Source: org_study_id

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