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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Submental Fat

Treatments: Drug: Normal saline; Drug: DWJ211

Study type: Interventional

Funder types: Industry

Identifiers

NCT03946592

DW_DWJ211301

Details and patient eligibility

About

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

Full description

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

Enrollment: 148 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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148 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

Inject the Drug into submental fat via subcutaneous

Treatment:

Drug: Normal saline

DWJ211 group

Experimental group

Description:

Inject the Drug into submental fat via subcutaneous

Treatment:

Drug: DWJ211