A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Weekly Alirocumab in Adults With Hypercholesterolemia
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 1\. Participant has elevated LDL-C level, as defined in the protocol
Locations
United States
Florida
Precision Clinical Research
RECRUITING
Sunrise
Georgia
Balanced Life Health Care Solutions
RECRUITING
Lawrenceville
Montana
Mercury Street Medical Group, PLLC
RECRUITING
Butte
North Carolina
Velocity Clinical Research - Durham
RECRUITING
Durham
Oregon
Velocity Clinical Research, Medford
RECRUITING
Medford
Texas
Velocity Clinical Research Dallas
RECRUITING
Dallas
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2026-06-29
Estimated Completion Date: 2027-02-23
Participants
Target number of participants: 420
Treatments
Experimental: Arm 1 - Low Dose
Experimental: Arm 2 - Medium Dose
Experimental: Arm 3 - High Dose
Experimental: Arm 4 - Control Dose
Related Therapeutic Areas
Sponsors
Leads: Regeneron Pharmaceuticals