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This study will investigate the efficacy, safety, and tolerability of VK2809 in lowering LDL-C and liver fat content in patients with primary hypercholesterolemia and fatty liver disease. The primary efficacy endpoint is percent change from baseline LDL-C at the end of the treatment period (Week 12). Secondary endpoints include effects on liver fat content and other liver and lipid markers, as well as effects on safety and tolerability, and pharmacokinetic (PK) measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo capsule |
|
| VK2809 (5mg) | Experimental | 5mg VK2809 capsule |
|
| VK2809 (10mg) | Experimental | 10mg VK2809 capsule |
|
| VK2809 (10mg QOD) | Experimental | 10mg VK2809 capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VK2809 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL-C in patients receiving VK2809 compared to placebo | 12 weeks |
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Inclusion Criteria:
Minimum of 10% liver fat as assessed by MRI - Proton Density Fat Fraction
Fasting serum LDL-C >130 mg/dL at screening, >110 mg/dL on lipid lowering medications
Any one of the following:
Body mass index (BMI) 18.50 - 40.00 kg/m2 inclusive at screening
Provide a personally-signed and dated informed consent document
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Mancini | Viking Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research, Inc. | Chandler | Arizona | 85224 | United States | ||
| SC Clinical Research |
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| Drug |
|
| Garden Grove |
| California |
| 92844 |
| United States |
| ACTCA | Los Angeles | California | United States |
| Catalina Research Institute | Montclair | California | 91763 | United States |
| North America Research, Inc | Pomona | California | 91767 | United States |
| Orange County Research Center | Tustin | California | 92780 | United States |
| Research Institute of South Florida | Miami | Florida | 33173 | United States |
| Research Institute of South Florida | Miami | Florida | United States |
| Avant Research Associates, LLC | Crowley | Louisiana | 70526 | United States |
| HCI- MetroMedic Walk-in | New Bedford | Massachusetts | 02740 | United States |
| HCI- MetroMedic Walk-in | New Bedford | Massachusetts | United States |
| Flint Clinical Research, PLLC | Flint | Michigan | 48503 | United States |
| Mid Hudson Medical | Hopewell Junction | New York | 12533 | United States |
| CHEAR Center, LLC | The Bronx | New York | 10459 | United States |
| Wake Research Associcates, LLC. | Raleigh | North Carolina | 27612 | United States |
| Avant Research | Beaumont | Texas | 77702 | United States |
| Clinical Trials of Texas, INC | San Antonio | Texas | 78229 | United States |
| Radiant Research, Inc. | San Antonio | Texas | 78229 | United States |
| Wasatch Clinical Research, LLC | Salt Lake City | Utah | 84107 | United States |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C539547 | 2-((3,5-dimethyl-4-(4'-hydroxy-3'-isopropylbenzyl)phenoxy)methyl)-4-(3-chlorophenyl)-2-oxido(1,3,2)dioxaphosphonane |
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