NCT07477704

A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia

A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Weekly Alirocumab in Adults With Hypercholesterolemia

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Alirocumab	Administered per the protocol

Timeline

• Start date: 2026-04-14
• Primary completion: 2026-10-20
• Completion: 2027-03-09
• First posted: 2026-03-17
• Last updated: 2026-03-17

Regulatory

• FDA-regulated drug study