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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Submental Fat

Intervention / Treatment
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* Drug: MT921
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT921<br>1% or 1.5%, subcutaneously administered at most 50 injections per treatment. | Drug: MT921<br>* Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.<br>|
| Placebo Comparator: Placebo<br>Subcutaneously administered at most 50 injections per treatment. | Drug: Placebo<br>* Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 4 weeks after the last treatment session |