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Completed

NCT Number: NCT05195112

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.

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Key information

Conditions

Submental Fat

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Inha University Hospital

Incheon, 22332, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

MT921

Drug

Active ingredient

Placebo

Drug

Normal Saline

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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. 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)

  5. 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

Other outcomes

  1. Caliper

    Time frame: 4 and 12 weeks

    Percentage of change in submental fat thickness as measured by Caliper

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2022
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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