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

Phase 2

Completed

• Conditions: Submental Fat
• Interventions: Drug: MT921; Drug: Placebo

• Registration Number: NCT04144049
• Lead Sponsor: Medy-Tox

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-10
• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-30
• Primary Completion: 2020-03-10
• Study Completion: 2020-04-23
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MT921	MT921	1% or 1.5%, subcutaneously administered at most 50 injections per treatment.
Placebo	Placebo	Subcutaneously administered at most 50 injections per treatment.

Primary Outcome Measures

Name	Time	Method
Responder rate of 2-grade improvement in CA-SMFRS	4 weeks after the last treatment session	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.
Responder rate of 2-grade improvement in PA-SMFRS	4 weeks after the last treatment session	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.
Responder rate of 1-grade improvement in CA-SMFRS	4 weeks after the last treatment session	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.
Responder rate of 1-grade improvement in PA-SMFRS	4 weeks after the last treatment session	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.

Trial Locations

Locations (1)

Chung-ang University Hospital; 🇰🇷 Seoul, Korea, Republic of