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| Name | Class |
|---|---|
| MB Clinical Research and Consulting LLC | UNKNOWN |
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The goal of this clinical trial is to learn if Obicetrapib works to change antioxidant levels in HDL and plasma, as well as retinal tissue. The main questions it aims to answer are:
Do Obicetrapib effect absorption of antioxidants in a person's blood or their eye tissue? Researchers will compare Obicetrapib to a placebo (a look-alike substance that contains no drug) to see if Obicetrapib helps improve a person's ability to absorb antioxidants.
Participants will:
Take Obicetrapib or a placebo every day for 4 months Visit the clinic once every 8 weeks for checkups and tests Have their blood taken and their eyes checked to measure antioxidant levels
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obicetrapib 10mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obicetrapib 10mg | Drug | Active Drug |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Percent Change of Antioxidant Levels within HDL | The primary efficacy endpoint is the effect of obicetrapib on the sum of the percent changes in lutein, zeaxanthin, and α-tocopherol levels within HDL particles from baseline to visit 4 (week 16) compared to placebo. | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Obicetrapib on Percent Changes of Antioxidant Levels in Retinal Tissue, Plasma, and HDL Particles | The secondary efficacy endpoints are the effect of obicetrapib compared to placebo on the percent changes from baseline to visit 3 (week 8) and baseline to visit 4 (week 16) for the following variables:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Excellence Medical Research | Recruiting | Miami Gardens | Florida | 33169 | United States |
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| Drug |
Placebo Control |
|
| 8 and 16 weeks |