A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab in Patients With Primary Hypercholesterolemia
The clinical trial for alirocumab, a monoclonal antibody targeting PCSK9, aims to establish its efficacy and safety in treating primary hypercholesterolemia with a novel dosing regimen of 300 mg every four weeks. This study is pivotal as it explores the potential for alirocumab to serve as a first-line treatment option, which could enhance its market position against competitors like Amgen's evolocumab. The successful demonstration of long-term safety and tolerability may lead to increased adoption in clinical practice, particularly among patients inadequately controlled on statin therapy. Given the growing emphasis on cardiovascular health and cholesterol management, the asset holds significant commercial potential in a lucrative market segment. Diligence should focus on the competitive landscape and potential reimbursement challenges.
Indication: Hypercholesterolemia
Modality: small molecule
Target: PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9)
Sponsor: Regeneron Pharmaceuticals
Source URL: ClinicalTrials.gov
Source updated: Mar 21, 2017
Ingested: Jun 17, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9)
View original source fields
Condition raw: Hypercholesterolemia
Condition normalized: Hypercholesterolemia
Modality raw: small molecule
Modality normalized: small molecule
Target raw: PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9)
Target normalized: PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9)