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

Medy-Tox176 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

176

Conditions

Submental Fat

Interventions

MT921DRUG

Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.

PlaceboDRUG

Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Chung-ang University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Responder rate of 2-grade improvement in CA-SMFRS

Proportion of subjects who have at least a 2-grade improvement from basleine on the Clinician Assessed-SubMental Fat Rating Scale (5-point scale, 0-No submental fat to 4-Excessive submental fat) at 4 weeks after the last treatment.

Time frame: 4 weeks after the last treatment session

Responder rate of 2-grade improvement in PA-SMFRS

Proportion of subjects who have at least a 2-grade improvement from basleine on the Patient Assessed-SubMental Fat Rating Scale (5-point scale, 0-No submental fat to 4-Excessive submental fat) at 4 weeks after the last treatment.

Time frame: 4 weeks after the last treatment session

Responder rate of 1-grade improvement in CA-SMFRS

Proportion of subjects who have at least a 1-grade improvement from basleine on the Clinician Assessed-SubMental Fat Rating Scale (5-point scale, 0-No submental fat to 4-Excessive submental fat) at 4 weeks after the last treatment.

Time frame: 4 weeks after the last treatment session

Responder rate of 1-grade improvement in PA-SMFRS

Proportion of subjects who have at least a 1-grade improvement from basleine on the Patient Assessed-SubMental Fat Rating Scale (5-point scale, 0-No submental fat to 4-Excessive submental fat) at 4 weeks after the last treatment.

Time frame: 4 weeks after the last treatment session

Data from ClinicalTrials.gov

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