Submental FatPhase 2NCT04144049
A Phase II Study to Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat
A Phase 2 study testing MT921 in people with Submental Fat, run by Medy-Tox at 1 site in South Korea.
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. 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
- 176 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Sep 2019to 23 Apr 2020
- Phase
- Phase 2
- 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
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- 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
Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.
PlaceboDrug
Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.
| Study group | Role | What they receive |
|---|---|---|
| MT921 | Experimental | 1% or 1.5%, subcutaneously administered at most 50 injections per treatment. Receives: Drug: MT921 |
| Placebo | Placebo comparator | Subcutaneously administered at most 50 injections per treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks after the last treatment session
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.
Measured: 4 weeks after the last treatment session
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.
Measured: 4 weeks after the last treatment session
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.
Measured: 4 weeks after the last treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start10 Sep 2019
- Primary completion10 Mar 2020
- Study completion23 Apr 2020
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 176 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
- NCT04144049
- Sponsor's protocol ID
- MT11-KR18SMF203
- Status last verified
- Jul 2020
- First submitted
- 28 Oct 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04144049
- Acronym / sponsor ID
- MT11-KR18SMF203
- Conditions
- Submental Fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 30 Oct 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT921 | Experimental | Drug: MT9211% or 1.5%, subcutaneously administered at most 50 injections per treatment. |
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneously administered at most 50 injections per treatment. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| MT921Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session. | Drug | MT921 |
| PlaceboSubcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session. | Drug | Placebo |
Primary outcome
Responder rate of 2-grade improvement in CA-SMFRS
Time frame: 4 weeks after the last treatment session
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.
Responder rate of 2-grade improvement in PA-SMFRS
Time frame: 4 weeks after the last treatment session
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.
Responder rate of 1-grade improvement in CA-SMFRS
Time frame: 4 weeks after the last treatment session
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.
Responder rate of 1-grade improvement in PA-SMFRS
Time frame: 4 weeks after the last treatment session
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.
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 29 Jul 2020.
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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 2 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 3 inclusion and 6 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 29 Jul 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Responder rate of 2-grade improvement in CA-SMFRS (time frame: 4 weeks after the last treatment session). The study lists 4 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 29 Jul 2020.