Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat

February 21, 2023 updated by: Medy-Tox

A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat

The purpose of this study is to evaluate the Efficacy and Safety of MT921 in Subjects with Moderate to Severe Submental fat compared with Placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults 19~65 years of age
  2. CA-SMFRS and PA-SMFRS score of 2 or 3
  3. Satisfaction level is 3points or less
  4. Voluntarily provide informed consent

Exclusion Criteria:

  1. Following history that can affect the efficacy and safety evaluation in the chin or neck area as judged by the investigator

    • Scars or skin lesion on the study treatment region
    • Liposuction or lipolytic material treatment to decrease submental fat
    • Permanent filler, synthetic implantation and autologous fat grafting
    • Within 1 year of screening visit, semi-permanent filler (Calcium Hydroxyapatite, collagen-stimulator, etc.), radio-frequency treatment, HIFU, thread, laser procedure and chemical peeling procedure over medium-depth
    • Within 6 months of screening visit, temporary filler (Hyaluronic acid, etc.) procedure on the chin or neck, injection of botulinum toxin, radio-frequency treatment, HIFU, thread, laser procedure and chemical peeling procedure over medium-depth
  2. BMI over 35.0 kg/m^2
  3. Submandibular enlargement due to causes other than localized subcutaneous fat (hyperthyroidism, cervical lymphadenopathy, etc.)
  4. Current or past dysphagia
  5. Judged difficult to measure submandibular fat due to sagging skin on the chin and neck or wide platysmal bands on the neck
  6. Bleeding or taking anticoagulant drugs (except for patients taking anticoagulant drugs, those who can discontinue administration from 3 days before injection to 24 hours after injection of the IP)
  7. Skin disease or would infection on the study treatment region
  8. Hypersensitivity to Lidocaine, Benzocaine, Procaine or the IP

  9. Pregnancy or breast feeding or female of child-bearing potential who has not agreed to use of medically acceptable contraception during the study period

    • All women of childbearing age have negative pregnancy test results can be enrolled in parallel with surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or menopause (amenorrhea for more than 12 months).
    • Medically acceptable contraception: Intrauterine device, Intrauterine system, vasectomy, tubal ligation, condom, Cervical cap, Contraceptive diaphragm, contraceptive sponges, spermicide, oral contraceptive pill and etc.
  10. Experience of other clinical trials within 30 days before screening
  11. Any other clinically meaningful conditions that are considered ineligible for the study in the medical judgement of principal investigator or sub-investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MT921
  • Injection volume/interval: 0.2mL/1.0cm
  • Number of Injection: Maximum 50 times
  • Concentration per unit area: 3mg/cm2
Drug: MT921
Active ingredient
Placebo Comparator: Placebo
  • Injection volume/interval: 0.2mL/1.0cm
  • Number of Injection: Maximum 50 times
  • Concentration per unit area: 0mg/cm2
Drug: Placebo
Normal Saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects whose CA-SMFRS (Clinician-Assessed Submental Fat Rating Scale) score changed
Time Frame: 12 weeks
Proportion of subjects whose CA-SMFRS decreased 1, 2 points or more compared the 12 weeks after the last administration day to before administration of the IP, Minimum value: 0 (best outcome) / Maximum value: 4 (worst outcome)
12 weeks
Proportion of subjects whose PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) score changed
Time Frame: 12 weeks
Proportion of subjects whose PA-MFRS decreased 1, 2 points or more compared the 12 weeks after the last administration day to before administration of the IP , Minimum value: 0 (worst outcome) / Maximum value: 10 (best outcome)
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects whose CA-SMFRS (Clinician-Assessed Submental Fat Rating Scale) score changed
Time Frame: 4 weeks
Proportion of subjects whose CA-SMFRS decreased 1, 2 points or more compared the 4 weeks after the last administration day to before administration of the IP, Minimum value: 0 (best outcome) / Maximum value: 4 (worst outcome)
4 weeks
Proportion of subjects whose PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) score changed
Time Frame: 4 weeks
Proportion of subjects whose PA-MFRS decreased 1, 2 points or more compared the 4 weeks after the last administration day to before administration of the IP , Minimum value: 0 (worst outcome) / Maximum value: 10 (best outcome)
4 weeks
PA-SMFIS (Patient Assessed-Submental Fat Impact Scale)
Time Frame: 4 and 12 weeks
Change PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) score compared 4 to 12 weeks after the last administration of the IP, Minimum value: 0 (worst outcome) / Maximum value: 10 (best outcome)
4 and 12 weeks
Measuring submental fat volume by MRI (magnetic resonance imaging)
Time Frame: 12 weeks
Confirmation the volume of submental fat compared the 12 weeks after the last administration to before administration of the IP measured by MRI (Number of Participants: approximately 120)
12 weeks
Satisfaction Evaluation by the subject
Time Frame: 4 and 12 weeks
A score of 5 (slightly satisfied) or higher in the subject satisfaction evaluation at 4 and 12 weeks after the last administration to before administration of the IP
4 and 12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Caliper
Time Frame: 4 and 12 weeks
Percentage of change in submental fat thickness as measured by Caliper
4 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medy-Tox

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MT11-KR19SMF309

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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