CClinicalTrials.gg
Sign In
CompletedNCT05195112Updated Feb 23, 2023

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

A Phase 3 interventional study of MT921 and Placebo in Submental Fat, sponsored by Medy-Tox. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-23.

Sponsored by Medy-Tox · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Submental Fat
03

In context

Lead sponsor

Medy-Tox is the lead sponsor of 48 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    MT921

    * Injection volume/interval: 0.2mL/1.0cm * Number of Injection: Maximum 50 times * Concentration per unit area: 3mg/cm2

    Drug: MT921

  • Placebo comparator
    Placebo

    * Injection volume/interval: 0.2mL/1.0cm * Number of Injection: Maximum 50 times * Concentration per unit area: 0mg/cm2

    Drug: Placebo

Interventions

  • DrugMT921

    Active ingredient

  • DrugPlacebo

    Normal Saline

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 12 weeks

  2. 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)

    Time frame: 12 weeks

Secondary outcomes

  1. 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)

    Time frame: 4 weeks

  2. 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)

    Time frame: 4 weeks

  3. 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)

    Time frame: 4 and 12 weeks

  4. 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)

    Time frame: 12 weeks

  5. 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

    Time frame: 4 and 12 weeks

Other outcomes

  1. Caliper

    Percentage of change in submental fat thickness as measured by Caliper

    Time frame: 4 and 12 weeks

07

Study locations

1 site
  • Inha University Hospital
    Incheon, 22332, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05195112
Lead sponsor
Medy-Tox
Responsible party
Sponsor
First posted
Jan 18, 2022
Start date
Dec 24, 2021
Primary completion
Feb 18, 2023
Completion
Feb 18, 2023
Last update
Feb 23, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Medy-Tox

Start the discussion