Evaluate the Efficacy and Safety of DWJ211 in Patient Wit... | NCT03946592

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

NCT03946592

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Completed

Last Update Posted

Apr 4, 2024Actual

Enrollment

148Actual

Phase

Phase 3

Conditions

Submental Fat

Interventions

Normal saline
DWJ211

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2019Actual

Primary Completion Date

Jul 2, 2020Actual

Completion Date

Jul 2, 2020Actual

First Submitted Date

May 9, 2019

First Submission Date that Met QC Criteria

May 9, 2019

First Posted Date

May 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2024

Last Update Posted Date

Apr 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

148Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo group	Placebo Comparator	Inject the Drug into submental fat via subcutaneous	Drug: Normal saline
DWJ211 group	Experimental	Inject the Drug into submental fat via subcutaneous	Drug: DWJ211

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Normal saline	Drug	Inject the Drug into submental fat via subcutaneous	Placebo group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PA-SMFRS, SA-SMFRS	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	12 week after last treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chung-ang university hospital		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided