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

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

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 Overview

• Status: Completed
• Conditions: Submental Fat
• Intervention / Treatment: Drug: MT921; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06973
    • Chung-Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medy-Tox

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): April 23, 2020

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MT11-KR18SMF203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No