At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Three Doses of SAR236553 (REGN727) Over 12 Weeks in Patients With Primary Hypercholesterolemia and LDL-cholesterol ≥100 mg/dL (≥2.59 mmol/L) on Ongoing Stable Atorvastatin Therapy
In Brief
A Phase 2 clinical trial evaluating Alirocumab, Placebo (for alirocumab), and 1 other intervention for Hypercholesterolemia. Completed, enrolled 100 participants across 4 sites.
Detailed Summary
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9). Primary Objective of the study: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥100 mg/dL (≥2.59 mmol/L) on ongoing stable atorvastatin therapy. Secondary Objectives: * To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment in comparison with placebo * To evaluate the safety and tolerability of alirocumab * To evaluate the development of anti-alirocumab antibodies * To evaluate the pharmacokinetics of alirocumab
Study Details
Timeline
Interventions
Two SC injections in the abdomen only
Two subcutaneous (SC) injections in the abdomen only Route of administration: subcutaneous injection (1 mL) in the abdomen
Orally once daily at a stable dose of 5 to 20 mg as background therapy Route of administration: oral administration in the evening