Clinical trial NCT05195112: Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Submental Fat
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2022-01-18
Enrollment: 240
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects whose CA-SMFRS (Clinician-Assessed Submental Fat Rating Scale) score changed
timeFrame: 12 weeks
measure: Proportion of subjects whose PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) score changed
timeFrame: 12 weeks
Secondary outcomes:
measure: Proportion of subjects whose CA-SMFRS (Clinician-Assessed Submental Fat Rating Scale) score changed
timeFrame: 4 weeks
measure: Proportion of subjects whose PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) score changed
timeFrame: 4 weeks
measure: PA-SMFIS (Patient Assessed-Submental Fat Impact Scale)
timeFrame: 4 and 12 weeks
measure: Measuring submental fat volume by MRI (magnetic resonance imaging)
timeFrame: 12 weeks
measure: Satisfaction Evaluation by the subject
timeFrame: 4 and 12 weeks
Other outcomes:
measure: Caliper
timeFrame: 4 and 12 weeks
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
References: