A Phase II Study to Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat

Medytox

Status and phase: Completed; Phase 2

Conditions: Submental Fat

Treatments: Drug: Placebo; Drug: MT921

Study type: Interventional

Funder types: Industry

Identifiers

NCT04144049

MT11-KR18SMF203

Details and patient eligibility

About

This study is a randomized, double-blind, placebo-controlled, dose-ranging, parallel, multi-center, phase II study to evaluate the efficacy and safety of MT921 in subjects with moderate to severe submental fat.

Enrollment: 176 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects over 19 and under 65 years old
• Subjects achieving CA-SMFRS and PA-SMFRS score of 2 or 3
• Subjects who voluntarily signed the Informed Consent

Exclusion criteria

• Subjects who had liposuction or other procedures on the treatment area that might affect the assessment.
• Subjects with BMI over 35.0kg/m^2
• Subjects with dysphagia
• Subjects who are allergic or hypersensitive to the investigational product
• Subjects who are pregnant or lactating, or does not agree to use an accepatble form of contraception during the clinical trial.
• Subjects who are otherwise deemed uneligible by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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176 participants in 2 patient groups, including a placebo group

MT921

Experimental group

Description:

1% or 1.5%, subcutaneously administered at most 50 injections per treatment.

Treatment:

Drug: MT921

Placebo

Placebo Comparator group

Description:

Subcutaneously administered at most 50 injections per treatment.

Treatment:

Drug: Placebo