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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This study will test the safety, tolerability, and bioeffects (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in hyperlipidemic patients with or without atorvastatin therapy. The study drug and placebo will be administered by subcutaneous injection at the clinic. There will be a total of 2 or 3 study drug injections over 16 clinic visits, which will include 3 overnight stays(study duration 148 days, not including the screening period). Patients on atorvastatin will take their daily dose in the morning for the duration of the study. Patients will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 with atorvastatin | Experimental | Dose 1 versus placebo |
|
| Group 2 with atorvastatin | Experimental | Dose 1 versus placebo |
|
| Group 3 with atorvastatin | Experimental | Dose 2 versus placebo |
|
| Group 4 with atorvastatin | Experimental | Dose 2 versus placebo |
|
| Group 5 with atorvastatin | Experimental | Dose 3 versus placebo |
|
| Group 6 with atorvastatin | Experimental | Dose 3 versus placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN727(SAR236553) | Drug | subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin. | visit 4 (day 1) to visit 16 (day 148) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the pharmacodynamic effect of REGN727 added to atorvastatin on lipids | Visit 4 (Day 1) to Visit 16 (Day 148) | |
| To assess the pharmacodynamic effect of monotherapy REGN727 in hyperlipidemic patients | Visit 4 (Day 1) to Visit 16 (Day 148) |
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Inclusion Criteria
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Gary Swergold, MD, PhD | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1 | Cincinnati | Ohio | United States | |||
| Site 2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22435370 | Derived | Stein EA, Mellis S, Yancopoulos GD, Stahl N, Logan D, Smith WB, Lisbon E, Gutierrez M, Webb C, Wu R, Du Y, Kranz T, Gasparino E, Swergold GD. Effect of a monoclonal antibody to PCSK9 on LDL cholesterol. N Engl J Med. 2012 Mar 22;366(12):1108-18. doi: 10.1056/NEJMoa1105803. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C571059 | alirocumab |
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| Group 7 without atorvastatin | Experimental | Dose 3 versus placebo |
|
| Group 8 with atorvastatin | Experimental | Dose4 versus placebo |
|
| To assess the pharmacokinetics of REGN727 in hyperlipidemic patients with or without atorvastatin | Visit 4 (Day 1) to Visit 16 (Day 148) |
| Knoxville |
| Tennessee |
| United States |
| D009750 |
| Nutritional and Metabolic Diseases |