TrialSignal
Clinical trial intelligence report
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
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 17, 2026
NCT ID
NCT01926782
Status
COMPLETED
Phase
Phase 3
Sponsor
Regeneron Pharmaceuticals
Executive brief
Investment-Ready Snapshot
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.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT01926782
Indication
Hypercholesterolemia
Modality
small molecule
Target
PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9)
Intervention
Placebo (for alirocumab), Alirocumab, Statin
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.