Submental FatPhase 3NCT05195112
Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat
A Phase 3 study testing MT921 in people with Submental Fat, run by Medy-Tox at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Submental Fat
- What is being tested?
- MT921
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Dec 2021to 18 Feb 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 19~65 years of age
- CA-SMFRS and PA-SMFRS score of 2 or 3
- Satisfaction level is 3points or less
- Voluntarily provide informed consent
Who cannot join
- 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
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- BMI over 35.0 kg/m^2
- Submandibular enlargement due to causes other than localized subcutaneous fat (hyperthyroidism, cervical lymphadenopathy, etc.)
- Current or past dysphagia
- Judged difficult to measure submandibular fat due to sagging skin on the chin and neck or wide platysmal bands on the neck
- 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)
- Skin disease or would infection on the study treatment region
- Hypersensitivity to Lidocaine, Benzocaine, Procaine or the IP
- 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.
- Experience of other clinical trials within 30 days before screening
- Any other clinically meaningful conditions that are considered ineligible for the study in the medical judgement of principal investigator or sub-investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Submental Fat
- Being tested
- MT921, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT921Drug
Active ingredient
PlaceboDrug
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| MT921 | Experimental | * Injection volume/interval: 0.2mL/1.0cm
* Number of Injection: Maximum 50 times
* Concentration per unit area: 3mg/cm2 Receives: Drug: MT921 |
| Placebo | Placebo comparator | * Injection volume/interval: 0.2mL/1.0cm
* Number of Injection: Maximum 50 times
* Concentration per unit area: 0mg/cm2 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects whose CA-SMFRS (Clinician-Assessed Submental Fat Rating Scale) score changed
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)
Measured: 12 weeks
Proportion of subjects whose PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) score changed
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)
Measured: 12 weeks
Secondary outcomes (5)
Proportion of subjects whose CA-SMFRS (Clinician-Assessed Submental Fat Rating Scale) score changed
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)
Measured: 4 weeks
Proportion of subjects whose PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) score changed
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)
Measured: 4 weeks
PA-SMFIS (Patient Assessed-Submental Fat Impact Scale)
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)
Measured: 4 and 12 weeks
Measuring submental fat volume by MRI (magnetic resonance imaging)
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)
Measured: 12 weeks
Satisfaction Evaluation by the subject
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
Measured: 4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start24 Dec 2021
- Primary completion18 Feb 2023
- Study completion18 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Submental FatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195112
- Sponsor's protocol ID
- MT11-KR19SMF309
- Status last verified
- Feb 2023
- First submitted
- 13 Dec 2021
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05195112
- Acronym / sponsor ID
- MT11-KR19SMF309
- Conditions
- Submental Fat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 24 Dec 2021 (actual)
- Primary completion
- 18 Feb 2023 (actual)
- Study completion
- 18 Feb 2023 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT921 | Experimental | Drug: MT921* Injection volume/interval: 0.2mL/1.0cm * Number of Injection: Maximum 50 times * Concentration per unit area: 3mg/cm2 |
| Placebo | Placebo comparator | Drug: Placebo* Injection volume/interval: 0.2mL/1.0cm * Number of Injection: Maximum 50 times * Concentration per unit area: 0mg/cm2 |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults 19~65 years of age
- CA-SMFRS and PA-SMFRS score of 2 or 3
- Satisfaction level is 3points or less
- Voluntarily provide informed consent
Key exclusion criteria (18 listed)
- Following history that can affect the efficacy and safety evaluation in the chin or neck area as judged by the investigator
- BMI over 35.0 kg/m^2
- Submandibular enlargement due to causes other than localized subcutaneous fat (hyperthyroidism, cervical lymphadenopathy, etc.)
- Current or past dysphagia
- Judged difficult to measure submandibular fat due to sagging skin on the chin and neck or wide platysmal bands on the neck
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT921Active ingredient | Drug | MT921 |
| PlaceboNormal Saline | Drug | Placebo |
Primary outcome
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)
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)
5 secondary outcomes
Proportion of subjects whose CA-SMFRS (Clinician-Assessed Submental Fat Rating Scale) score changed
Time frame: 4 weeks
Proportion of subjects whose PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) score changed
Time frame: 4 weeks
PA-SMFIS (Patient Assessed-Submental Fat Impact Scale)
Time frame: 4 and 12 weeks
Measuring submental fat volume by MRI (magnetic resonance imaging)
Time frame: 12 weeks
Satisfaction Evaluation by the subject
Time frame: 4 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MT921 in people with Submental Fat, run by Medy-Tox at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects whose CA-SMFRS (Clinician-Assessed Submental Fat Rating Scale) score changed (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.