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

NCT ID: NCT04144049

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-10

Study Completion Date

2020-04-23

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.

Detailed Description

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Conditions

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Submental Fat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MT921

1% or 1.5%, subcutaneously administered at most 50 injections per treatment.

Group Type EXPERIMENTAL

MT921

Intervention Type DRUG

Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.

Placebo

Subcutaneously administered at most 50 injections per treatment.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.

Interventions

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MT921

Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.

Intervention Type DRUG

Placebo

Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.

Intervention Type DRUG

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medy-Tox

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chung-ang University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MT11-KR18SMF203

Identifier Type: -

Identifier Source: org_study_id

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