Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the safety and efficacy of different doses of CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with moderate hypertriglyceridemia and (2) fasting LDL-C levels in combination with a statin in patients with hypercholesterolemia who are on a statin.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAT-2003 or Placebo Dose 1 | Experimental | Daily for 28 days in patients with moderate hypertriglyceridemia |
|
| CAT-2003 or Placebo Dose 2 | Experimental | Daily for 28 days in patients with moderate hypertriglyceridemia |
|
| CAT-2003 or Placebo Dose 3 | Experimental | Daily for 28 days in patients with moderate hypertriglyceridemia |
|
| CAT-2003 or Placebo Dose 4 | Experimental | Daily for 28 days in patients with hypercholesterolemia who are on a statin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAT-2003 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute and percent change from baseline in plasma triglycerides in patients with hypertriglyceridemia | 4 weeks | |
| Absolute and percent change from baseline in plasma low density lipoprotein-cholesterol in patients with hypercholesterolemia | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute and percent change from baseline in plasma non-high-density lipoprotein cholesterol | 4 weeks | |
| Pharmacodynamic effects of CAT-2003 on other lipid biomarkers in patients with hyperlipidemia | 4 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muscle Shoals | Alabama | 35662 | United States | |||
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug |
|
| Statin | Drug | All patients being treated with a stable dose of a statin prior to enrollment continue on their dosing regimen. |
|
| Frequency of adverse events | Safety and tolerability 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 |
| Los Angeles |
| California |
| 90057 |
| United States |
| Jacksonville | Florida | 32223 | United States |
| Miami | Florida | 33143 | United States |
| Winter Park | Florida | 32792 | United States |
| Kansas City | Kansas | 66160 | United States |
| Louisville | Kentucky | 40213 | United States |
| Auburn | Maine | 04120 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Cincinnati | Ohio | 45227 | United States |
| Cincinnati | Ohio | 45246 | United States |
| Sainte-Foy | Quebec | G1V 4M6 | Canada |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006937 | Hypercholesterolemia |
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
Not provided
Not provided
| ID | Term |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
Not provided
Not provided