NCT07477704RecruitingPhase 2
A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Weekly Alirocumab in Adults With Hypercholesterolemia
Regeneron Pharmaceuticals34 sites in 1 country420 target enrollmentStarted: June 17, 2026Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 420
- Locations
- 34
- Primary Endpoint
- Percent change in LDL-C
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1. Participant has elevated LDL-C level, as defined in the protocol
Exclusion Criteria
- •Participant plans to initiate or change dose of lipid-lowering therapy
- •Use of any PCSK9 inhibitors
- •NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Arms & Interventions
Arm 2 - Medium Dose
Experimental
Intervention: Alirocumab (Drug)
Arm 4 - Control Dose
Experimental
Intervention: Alirocumab (Drug)
Arm 3 - High Dose
Experimental
Intervention: Alirocumab (Drug)
Arm 1 - Low Dose
Experimental
Intervention: Alirocumab (Drug)
Outcomes
Primary Outcomes
Percent change in LDL-C
Time Frame: From Baseline through Week 12
Secondary Outcomes
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)(Through Week 32)
- Severity of TEAEs(Through Week 32)
- Percent change in Apolipoprotein B (ApoB)(From Baseline through Week 24)
- Percent change in total cholesterol(From Baseline through Week 24)
- Percent change in triglycerides(From Baseline through Week 24)
- Percent change in non-High-Density Lipoprotein-Cholesterol (HDL-C)(From Baseline through Week 24)
- Concentrations of total alirocumab in serum(Through Week 32)
- Percent change in HDL-C(From Baseline through Week 24)
- Number of participants meeting up-titration of dose of alirocumab(Week 12 through Week 24)
- Concentrations of free Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) in serum(Through Week 32)
- Percent change in LDL-C(From Baseline through Week 24)
Investigators
Study Sites (34)
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