NCT03224117

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 26, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2018

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

July 19, 2017

Last Update Submit

April 3, 2024

Conditions

Treatment for Submental Fat

Outcome Measures

Primary Outcomes (4)

  • 2-grade response : PA-SMFRS

    proportion of subject who simultaneously have at least a 2 grade improvement from baseline on the PA-SMFRS at 4weeks after the last treatment

    4 week after last treatment

  • 2-grade response : SA-SMFRS

    proportion of subject who simultaneously have at least a 2-grade improvement from baseline on the SA-SMFRS at 4weeks after the last treatment

    4 week after last treatment

  • 1-grade response : PA-SMFRS

    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 week after last treatment

  • 1-grade response : SA-SMFRS

    proportion of subject who simultaneously have at least a 1-grade improvement from baseline on the SA-SMFRS at 4weeks after the last treatment

    4 week after last treatment

Secondary Outcomes (4)

  • MRI volume response rate

    4 week after last treatment

  • improvement: SA-SMFIS

    4 week after last treatment

  • obtained 5 score : SSS

    4 week after last treatment

  • thickness response rate : caliper

    4 week after last treatment

Study Arms (4)

Placebo

PLACEBO COMPARATOR

SQ injection

Drug: Normal saline

DWJ211_0.5%

EXPERIMENTAL

SQ injection with DWJ211 0.5%

Drug: DWJ211

DWJ211_1%

EXPERIMENTAL

SQ injection with DWJ211 1.0%

Drug: DWJ211

DWJ211_2%

EXPERIMENTAL

SQ injection with DWJ211 2.0%

Drug: DWJ211

Interventions

DWJ211DRUG

inject the Drug into submental fat via subcutaneous

DWJ211_0.5%DWJ211_1%DWJ211_2%
Normal salineDRUG

inject the Drug into submental fat via subcutaneous

Placebo

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chung-ang university hospital

Seoul, South Korea

Location

Konkuk university medical center

Seoul, South Korea

Location

Seoul Asan medical center

Seoul, South Korea

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Beom Joon Kim, MD, PhD

    Chung-Ang University Hosptial, Chung-Ang University College of Medicine

    STUDY CHAIR

  • Yang-won Lee, MD, PhD

    Konkuk University Medical Center

    PRINCIPAL INVESTIGATOR

  • Chong-hyun Won, MD, PhD

    Seoul Asan medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2017

First Posted

July 21, 2017

Study Start

October 26, 2017

Primary Completion

June 29, 2018

Study Completion

June 29, 2018

Last Updated

April 4, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(3)