Clinical trial NCT05129241: Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector
Official title: Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector (MARS-NIS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Hypercholesterolaemia and Mixed Dyslipidaemia
Atherosclerotic Cardiovascular Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2021-11-22
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia and confirmed cardiovascular disease and with regular additional risk factors, and/or patients with confirmed familial heterozygous hypercholesterolaemia for whom the treating physician has decided to initiate lipid-lowering treatment with the PRALUENT® 2 ml SYDNEY auto-injector, irrespective of participation in the study.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Absolute change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)
timeFrame: from baseline to week 12
measure: Percent change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)
timeFrame: from baseline to week 12
measure: Treatment acceptance assessed using the Injection Treatment Acceptance Questionnaire (ITAQ)
timeFrame: week 12
Secondary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 12 weeks
measure: Number of quality defects assessed using product complaints
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Germany
country: Germany
facility: Investigational Site Number
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Parhofer KG, Bramlage P, Gries C, Harder C, Look C, Paar WD, Rauch-Krohnert U. Lipid-Lowering Efficiency and Safety of Alirocumab 300 mg Using a 2-mL Autoinjector Device in Real-World Practice: The MARS Study. Drugs Real World Outcomes. 2025 Mar;12(1):63-74. doi: 10.1007/s40801-024-00471-w. Epub 2025 Jan 28.