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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03946592

Acronym

SMF

Enrollment

148

Registered

2019-05-10

Start date

2019-05-15

Completion date

2020-07-02

Last updated

2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Submental Fat

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)

Interventions

DRUGNormal saline

Inject the Drug into submental fat via subcutaneous

DRUGDWJ211

Inject the Drug into submental fat via subcutaneous

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
PA-SMFRS, SA-SMFRS	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026