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

NCT03946592 | Completed Phase 3

• 1 other identifier: DW_DWJ211301
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Submental Fat

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Normal saline DRUG

Inject the Drug into submental fat via subcutaneous

Placebo group

DWJ211 DRUG

Inject the Drug into submental fat via subcutaneous

DWJ211 group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.

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.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Chung-ang university hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 10, 2019
• Study Start: May 15, 2019
• Primary Completion: July 2, 2020
• Study Completion: July 2, 2020
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)