Non-interventional Study on the Monthly Administration of... | NCT05129241

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

NCT05129241

Sponsor

Sanofi

Status

Completed

Last Update Posted

Mar 24, 2025Actual

Enrollment

163Actual

Phase

Not provided

Conditions

Primary Hypercholesterolaemia and Mixed Dyslipidaemia
Atherosclerotic Cardiovascular Disease

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1265-6221	Registry Identifier	ICTRP

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 18, 2021Actual

Primary Completion Date

Feb 16, 2023Actual

Completion Date

Feb 16, 2023Actual

First Submitted Date

Nov 15, 2021

First Submission Date that Met QC Criteria

Nov 15, 2021

First Posted Date

Nov 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2025

Last Update Posted Date

Mar 24, 2025Actual

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

163Actual

Label	Type	Description	Intervention Names
Cohort 1		Patients 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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
Treatment acceptance assessed using the Injection Treatment Acceptance Questionnaire (ITAQ)		week 12

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with adverse events		up to 12 weeks
Number of quality defects assessed using product complaints		up to 12 weeks

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39875772	Result	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.

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases