Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector

Completed

• Conditions: Primary Hypercholesterolaemia and Mixed Dyslipidaemia; Atherosclerotic Cardiovascular Disease

• Registration Number: NCT05129241
• Lead Sponsor: Sanofi

Brief Summary

Primary objectives:

* To assess the effectiveness of the PRALUENT® 2 ml SYDNEY auto-injector as measured by the lipid-lowering effect of alirocumab after approx. 12 weeks treatment

* To assess the treatment satisfaction, as well as patient adherence and persistence after approximately 12 weeks of treatment with the PRALUENT® 2 ml SYDNEY auto-injector

Secondary objective:

Safety and tolerability

Detailed Description

Study duration per participant is approximately 12 weeks

Study Timeline

• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-11-15
• Study Start: 2021-11-18
• Study First Posted: 2021-11-22
• Primary Completion: 2023-02-16
• Study Completion: 2023-02-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

Inclusion Criteria

• Primary hypercholesterolaemia (heterozygous familial or non-familial) or mixed dyslipidaemia AND confirmed vascular disease(*) AND other regular risk factors(**), OR confirmed familial heterozygous hypercholesterolaemia
• Documented maximum dietary and drug lipid-lowering therapy within the last 12 months
• Inadequate reduction of low-density lipoprotein cholesterol (LDL-C) despite maximum possible dietary and lipid-lowering therapy
• The decision of the treating physician to use the PRALUENT® 2 ml SYDNEY auto-injector regardless of study enrolment
• No previous therapy with a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor OR prior treatment with a PCSK9 inhibitor every 2 weeks (Q2W) or monthly (Q4W)
• Signed Informed Consent Form

(*) Coronary heart disease (CHD), cerebrovascular manifestation, peripheral arterial occlusive disease (PAOD)

(**) For cardiovascular events (e.g. diabetes mellitus, renal function glomerular filtration rate (GFR) < 60 ml/min)

Exclusion Criteria

• Planned or existing pregnancy, cancer, drug or alcohol abuse, dementia, or general inability to understand the content of the observational study
• Existing treatment by lipid apheresis
• Age < 18 years
• Contraindications to treatment with alirocumab (PRALUENT®) according to the SmPC
• Current participation in a clinical study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment acceptance assessed using the Injection Treatment Acceptance Questionnaire (ITAQ)	week 12
Absolute change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)	from baseline to week 12
Percent change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)	from baseline to week 12

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events	up to 12 weeks
Number of quality defects assessed using product complaints	up to 12 weeks

Trial Locations

Locations (1)

Investigational Site Number; 🇩🇪 Germany, Germany