Skip to main content
OpenTrials
Completed

NCT Number: NCT04144049

A 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Submental Fat

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chung-ang University Hospital

Seoul, 06973, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

MT921

Drug

Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.

Placebo

Drug

Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 30, 2019
Registry last updated
Jul 29, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.