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The purpose of this research study is to determine the safety and efficacy of 10XB-101 vs. vehicle (placebo) for adults with excessive submental fat (SMF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10XB-101 Solution for Injection, 2.0% | Experimental | Participants receive 10XB-101 Solution for Injection, 2.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments. |
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| 10XB-101 Solution for Injection, 3.0% | Experimental | Participants receive 10XB-101 Solution for Injection, 3.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments. |
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| 10XB-101 Solution for Injection, 4.5% | Experimental | Participants receive 10XB-101 Solution for Injection, 4.5% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments. |
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| 10XB-101 Vehicle Solution for Injection | Placebo Comparator | Participants receive 10XB-101 Vehicle Solution for Injection, via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10XB-101 Solution for Injection | Drug | One of the three concentrations of 10XB-101 will be evaluated against placebo for submental fat reduction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Submental Fat Scale (CSFS) | Change from Baseline after final treatment. CSFS is a 5 point scale, with a higher score indicating higher severity | 24 weeks after final injection treatment |
| Patient Submental Fat Scale (PSFS) | Change from Baseline after final treatment. PSFS is a 5 point scale, with a higher score indicating higher severity | 24 weeks after final injection treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 03 | Encino | California | 91436 | United States | ||
| Site 02 |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| 10XB-101 Vehicle Solution for Injection | Drug | This is the placebo control |
|
| San Diego |
| California |
| 92122 |
| United States |
| Site 01 | San Diego | California | 92123 | United States |
| Site 04 | Rolling Meadows | Illinois | 60008 | United States |