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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT921 | Experimental | 1% or 1.5%, subcutaneously administered at most 50 injections per treatment. |
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| Placebo | Placebo Comparator | Subcutaneously administered at most 50 injections per treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT921 | Drug | Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-ang University Hospital | Seoul | 06973 | South Korea |
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| Placebo | Drug | Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session. |
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