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| Name | Class |
|---|---|
| Therapeutics, Inc. | INDUSTRY |
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The goal of this clinical trial is to test the safety and effectiveness of an injection study drug in decreasing bilateral flank adiposity.
The main question it aims to answer is:
•How safe and effective is the injection study drug in removing bilateral flank adiposity compared to a placebo?
Participants will be:
Fifteen subjects with bilateral flank adiposity will be enrolled across 1-3 sites in the USA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10XB-101 Solution for Injection, 6.0% | Experimental | Participants receive 10XB-101 Solution for Injection, 6.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4 weeks for up to 6 treatments. |
|
| Placebo Solution for Injection | Placebo Comparator | Participants receive Placebo Solution for Injection, via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4 weeks for up to 6 treatments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10XB-101 Solution for Injection, 6.0% | Drug | The active drug (adipolytic) given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Volumetric measurements | Change from Baseline until end of study. Volumetric measurements will be obtained on each right and left flanks thru a standard photographic assessment. | 24 weeks after final injection treatment |
| Flank Skin Laxity Scale (FSLS) | Change from Baseline on each flank after final treatment. Flank Skin Laxity Scale (FSLS) is a 4 point scale, with a score of 0 for no skin folds, and a score of 3 for severe or worse skin folds.A higher score means a worse outcome. | 24 weeks after final injection treatment |
| Clinician Global Impression of Change (CGIC) | Change from Baseline on each flank after final treatment. Clinician Global Impression of Change (CGIC) is a 7-point bi-directional scale with 1 as much improved and 7 as much worse. | 24 weeks after final injection treatment |
| Patient Global Impression of Change (PGIC) | Change from Baseline on each flank after final treatment. Patient Global Impression of Change (PGIC) is a 7-point bi-directional scale with 1 as much improved and 7 as much worse. | 24 weeks after final injection treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Dobak, M.D. | 10xBio, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site #01 | Rolling Meadows | Illinois | 60008 | 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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Active drug 6% vs Placebo
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1:1 ratio
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| Placebo Solution for Injection (no active ingredient) | Drug | Placebo given as subcutaneous injection on either the right or left flank every 4 weeks for 20 weeks. |
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|
| New Brighton |
| Minnesota |
| 55112 |
| United States |