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

NCT04144049 | Completed Phase 2

• 1 other identifier: MT11-KR18SMF203
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Submental Fat

Outcome Measures

Primary Outcomes (4)

• Responder rate of 2-grade improvement in CA-SMFRS

  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.

  4 weeks after the last treatment session

• Responder rate of 2-grade improvement in PA-SMFRS

  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.

  4 weeks after the last treatment session

• Responder rate of 1-grade improvement in CA-SMFRS

  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 weeks after the last treatment session

• Responder rate of 1-grade improvement in PA-SMFRS

  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.

  4 weeks after the last treatment session

Study Arms (2)

MT921

EXPERIMENTAL

1% or 1.5%, subcutaneously administered at most 50 injections per treatment.

Drug: MT921

Placebo

PLACEBO COMPARATOR

Subcutaneously administered at most 50 injections per treatment.

Drug: Placebo

Interventions

MT921 DRUG

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

MT921

Placebo DRUG

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

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:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (1)

Chung-ang University Hospital

Seoul, 06973, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: September 10, 2019
• Primary Completion: March 10, 2020
• Study Completion: April 23, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

KR (1)