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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT921 | Experimental |
|
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT921 | Drug | Active ingredient |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 4 weeks after the last administration day to before administration of the IP, Minimum value: 0 (best outcome) / Maximum value: 4 (worst outcome) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Caliper | Percentage of change in submental fat thickness as measured by Caliper | 4 and 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
Following history that can affect the efficacy and safety evaluation in the chin or neck area as judged by the investigator
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
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inha University Hospital | Incheon | 22332 | South Korea |
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| Drug |
Normal Saline |
|
| 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 4 weeks after the last administration day to before administration of the IP , Minimum value: 0 (worst outcome) / Maximum value: 10 (best outcome) |
| 4 weeks |
| PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) | 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 and 12 weeks |
| Measuring submental fat volume by MRI (magnetic resonance imaging) | 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) | 12 weeks |
| Satisfaction Evaluation by the subject | 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 | 4 and 12 weeks |