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NCT01926782COMPLETEDanonymous

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

Sponsor

Source record

Regeneron Pharmaceuticals

Phase

Source record

Phase 3

Modality

AI-normalized

small molecule

Target

AI-normalized

PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9)

Indication / condition

AI-normalized

Hypercholesterolemia

Intervention

Source record

Placebo (for alirocumab), Alirocumab, Statin

Source & freshness

Source record

NCT ID

NCT01926782

Original source

ClinicalTrials.gov

Source last updated

Mar 21, 2017

Ingested at

Jun 17, 2026

Internal sync

Jun 17, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT01926782

Title

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

Sponsor

Regeneron Pharmaceuticals

Status

COMPLETED

Phase

Phase 3

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)

Interventions

Placebo (for alirocumab), Alirocumab, Statin

Public preview

Source record

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.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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