A Phase 2 interventional study of Alirocumab in Hypercholesterolemia, sponsored by Regeneron Pharmaceuticals. Recruiting at 34 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment
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:
Key Inclusion Criteria:
1. Participant has elevated LDL-C level, as defined in the protocol
Key Exclusion Criteria:
NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Drug: Alirocumab
Drug: Alirocumab
Drug: Alirocumab
Drug: Alirocumab
Administered per the protocol
Also known as: Praluent®, REGN727, SAR236553
Percent change in LDL-C
Time frame: From Baseline through Week 12
Concentrations of total alirocumab in serum
Time frame: Through Week 20
Concentrations of free Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) in serum
Time frame: Through Week 20
Percent change in LDL-C
Time frame: From Baseline through Week 8
Percent change in total cholesterol
Time frame: From Baseline through Week 12
Percent change in non-High-Density Lipoprotein-Cholesterol (HDL-C)
Time frame: From Baseline through Week 12
Percent change in HDL-C
Time frame: From Baseline through Week 12
Percent change in triglycerides
Time frame: From Baseline through Week 12
Percent change in Apolipoprotein B (ApoB)
Time frame: From Baseline through Week 12
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through Week 20
Severity of TEAEs
Time frame: Through Week 20
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Regeneron Pharmaceuticals