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

NCT05195112 | Completed Phase 3

• 1 other identifier: MT11-KR19SMF309
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Submental Fat

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  12 weeks

Secondary Outcomes (5)

• Proportion of subjects whose CA-SMFRS (Clinician-Assessed Submental Fat Rating Scale) score changed

  4 weeks

• Proportion of subjects whose PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) score changed

  4 weeks

• PA-SMFIS (Patient Assessed-Submental Fat Impact Scale)

  4 and 12 weeks

• Measuring submental fat volume by MRI (magnetic resonance imaging)

  12 weeks

• Satisfaction Evaluation by the subject

  4 and 12 weeks

Other Outcomes (1)

• Caliper

  4 and 12 weeks

Study Arms (2)

MT921

EXPERIMENTAL

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

Drug: MT921

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

MT921 DRUG

Active ingredient

MT921

Placebo DRUG

Normal Saline

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (1)

Inha University Hospital

Incheon, 22332, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 18, 2022
• Study Start: December 24, 2021
• Primary Completion: February 18, 2023
• Study Completion: February 18, 2023
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

KR (1)