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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04144049
Other study ID # MT11-KR18SMF203
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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