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This study is researching an experimental drug called alirocumab, referred to as "study drug". In the United States, alirocumab is approved for the treatment of hypercholesterolemia (high blood cholesterol levels).
The aim of the study is to see how safe and effective alirocumab is when given weekly to adult participants who have hypercholesterolemia.
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Low Dose | Experimental |
| |
| Arm 2 - Medium Dose | Experimental |
| |
| Arm 3 - High Dose | Experimental |
| |
| Arm 4 - Control Dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alirocumab | Drug | Administered per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in LDL-C | From Baseline through Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of total alirocumab in serum | Through Week 20 | |
| Concentrations of free Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) in serum | Through Week 20 | |
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Key Inclusion Criteria:
1. Participant has elevated LDL-C level, as defined in the protocol
Key Exclusion Criteria:
NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Recruiting | Anaheim | California | 92801 | United States | |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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|
| Percent change in LDL-C |
| From Baseline through Week 8 |
| Percent change in total cholesterol | From Baseline through Week 12 |
| Percent change in non-High-Density Lipoprotein-Cholesterol (HDL-C) | From Baseline through Week 12 |
| Percent change in HDL-C | From Baseline through Week 12 |
| Percent change in triglycerides | From Baseline through Week 12 |
| Percent change in Apolipoprotein B (ApoB) | From Baseline through Week 12 |
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Through Week 20 |
| Severity of TEAEs | Through Week 20 |
| Cenexel CNS |
| Recruiting |
| Los Alamitos |
| California |
| 90720 |
| United States |
| Diablo Clinical Research - Flourish Research | Recruiting | Walnut Creek | California | 94598 | United States |
| Tampa Bay Medical Research | Recruiting | Clearwater | Florida | 33761 | United States |
| Southwest General Healthcare Center | Recruiting | Fort Myers | Florida | 33907 | United States |
| Precision Clinical Research | Recruiting | Sunrise | Florida | 33351 | United States |
| K2 Medical Research The Villages | Recruiting | The Villages | Florida | 32159 | United States |
| Center for Advanced Research and Education | Recruiting | Gainesville | Georgia | 30501 | United States |
| Balanced Life Health Care Solutions | Recruiting | Lawrenceville | Georgia | 30046 | United States |
| East-West Medical Research Institute | Recruiting | Honolulu | Hawaii | 96814 | United States |
| L-MARC Research Center | Recruiting | Louisville | Kentucky | 40213 | United States |
| Tandem Clinical Research | Recruiting | Marrero | Louisiana | 70072 | United States |
| Mercury Street Medical Group, PLLC | Recruiting | Butte | Montana | 59701 | United States |
| Velocity Clinical Research - Omaha | Recruiting | Omaha | Nebraska | 68134 | United States |
| Palm Research Center, Mountainview Medical Center | Recruiting | Las Vegas | Nevada | 89128 | United States |
| Velocity Clinical Research - Durham | Recruiting | Durham | North Carolina | 27701 | United States |
| Ohio Clinical Trials | Recruiting | Columbus | Ohio | 43212 | United States |
| AMR Norman | Recruiting | Norman | Oklahoma | 73069 | United States |
| Lynn Health Science Institute | Recruiting | Oklahoma City | Oklahoma | 73112 | United States |
| Velocity Clinical Research, Medford | Recruiting | Medford | Oregon | 97504 | United States |
| Altoona Center for Clinical Research | Recruiting | Duncansville | Pennsylvania | 16635 | United States |
| Tribe Clinical Research | Recruiting | Greenville | South Carolina | 29607 | United States |
| Coastal Carolina Research Center_North Charleston | Recruiting | North Charleston | South Carolina | 29405 | United States |
| Velocity Clinical Research Dallas | Recruiting | Dallas | Texas | 75230 | United States |
| Be Well Clinical Studies - Round Rock | Recruiting | Round Rock | Texas | 78681 | United States |
| Flourish Research - San Antonio Medical Trials | Recruiting | San Antonio | Texas | 78229 | United States |
| Endeavor Clinical Trials | Recruiting | San Antonio | Texas | 78240 | United States |
| Consano Clinical Research, LLC | Recruiting | Shavano Park | Texas | 78231 | United States |
| Charlottesville Medical Research | Recruiting | Charlottesville | Virginia | 22911 | United States |
| Rainier Clinical Research Center | Recruiting | Renton | Washington | 98057 | United States |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C571059 | alirocumab |
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