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

Submental Fat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04144049
• Other study ID #: MT11-KR18SMF203
• Status: Completed
• Phase: Phase 2
• Start date: September 10, 2019
• Est. completion date: April 23, 2020

Study information

• Verified date: July 2020
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: April 23, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Submental Fat

Intervention

Drug:
• MT921
Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.
• Placebo
Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.

Locations

Country	Name	City	State
Korea, Republic of	Chung-ang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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