A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Weekly Alirocumab in Adults With Hypercholesterolemia
Regeneron Pharmaceuticals
Summary
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
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: 1\. Participant has elevated LDL-C level, as defined in the protocol Key Exclusion Criteria: 1. Participant plans to initiate or change dose of lipid-lowering therapy 2. Use of any PCSK9 inhibitors NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Interventions
- DrugAlirocumab
Administered per the protocol
Locations (6)
- Precision Clinical ResearchSunrise, Florida
- Balanced Life Health Care SolutionsLawrenceville, Georgia
- Mercury Street Medical Group, PLLCButte, Montana
- Velocity Clinical Research - DurhamDurham, North Carolina
- Velocity Clinical Research, MedfordMedford, Oregon
- Velocity Clinical Research DallasDallas, Texas