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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Treatment for Submental Fat

Treatments: Drug: DWJ211; Drug: Normal saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT03224117

DW_DWJ211001

Details and patient eligibility

About

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

Full description

DWJ211

_ reduction of moderate or severe submental fat

Enrollment: 140 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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.
2. Dissatisfaction with the submental area expressed by the subject as a rating of 1~3 using the SSS as determinded on Visit 1.
3. less than 35kg/m2 in body mass index on Visit1.
4. subject who will agree with the no treatment for the procedure that may affect to reduction or the submental fat.
5. subject who will agree with maintaining their body weight.

Exclusion criteria

1. History of any intervention to treat SMF
2. 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.
3. Evidence of any cause of enlargement in the submental area.
4. history or current symptoms of dysphagia.
5. a result on coagulation tests that indicates the presence of any clinically significant bleeding disorder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

SQ injection

Treatment:

Drug: Normal saline

DWJ211_0.5%

Experimental group

Description:

SQ injection with DWJ211 0.5%

Treatment:

Drug: DWJ211

DWJ211_1%

Experimental group

Description:

SQ injection with DWJ211 1.0%

Treatment:

Drug: DWJ211

DWJ211_2%

Experimental group

Description:

SQ injection with DWJ211 2.0%

Treatment:

Drug: DWJ211