A Phase II Study to Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04144049

Enrollment

176

Registered

2019-10-30

Start date

2019-09-10

Completion date

2020-04-23

Last updated

2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Submental Fat

Brief summary

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.

Interventions

DRUGMT921

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Responder rate of 2-grade improvement in CA-SMFRS	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.
Responder rate of 2-grade improvement in PA-SMFRS	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.
Responder rate of 1-grade improvement in CA-SMFRS	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.
Responder rate of 1-grade improvement in PA-SMFRS	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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026