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The purpose of this study is to determine the safety and efficacy of multiple doses of CAT-2003 in patients with severe hypertriglyceridemia either naive or refractory to current therapy. The study will evaluate effects of CAT-2003 on fasting and postprandial total triglycerides and chylomicron triglyceride levels in patients with severe hypertriglyceridemia.
This is a single-blind study. All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAT-2003 or Placebo | Experimental | All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAT-2003 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events | Safety will be assessed for all enrolled patients from the time the patient signs the informed consent through post-treatment follow-up. Safety parameters include physical exam, vital signs, clinical laboratory tests, ECGs and concomitant medications. | 4 weeks |
| Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | 33143 | United States | |||
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D015228 | Hypertriglyceridemia |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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|
| 4 weeks |
| Indianapolis |
| Indiana |
| 46260 |
| United States |
| Auburn | Maine | 04210 | United States |
| Cincinnati | Ohio | 45227 | United States |