A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia
Part of paid clinical trials in Sunrise, Florida.
- Sponsor
- Regeneron Pharmaceuticals
- Study ID
- NCT07477704
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Alirocumab — DRUGAdministered per the protocol
Study Details
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: * What side effects may happen from taking the study drug once a week * How much study drug is in the blood at different times
Key Dates
- Start date
- Jun 29, 2026
- Status verified
- Jun 2026
- Primary completion
- Dec 29, 2026
- Completion
- Feb 23, 2027
Study Design
- Enrollment
- 420 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 1 - Low Dose
- Experimental: Arm 2 - Medium Dose
- Experimental: Arm 3 - High Dose
- Experimental: Arm 4 - Control Dose
Primary Outcome Measure
Percent change in LDL-C [ Time Frame: From Baseline through Week 12 ]
Central Contacts
- Clinical Trials Administrator844-734-6643
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Precision Clinical Research | Sunrise | Florida | 33351 | - |
| Balanced Life Health Care Solutions | Lawrenceville | Georgia | 30046 | - |
| Mercury Street Medical Group, PLLC | Butte | Montana | 59701 | - |
| Velocity Clinical Research - Durham | Durham | North Carolina | 27701 | - |
| Velocity Clinical Research, Medford | Medford | Oregon | 97504 | - |
| Velocity Clinical Research Dallas | Dallas | Texas | 75230 | - |
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