Primary Hypercholesterolaemia and Mixed DyslipidaemiaMARSNCT05129241
Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector
An observational study of Primary Hypercholesterolaemia and Mixed Dyslipidaemia and Atherosclerotic Cardiovascular Disease, run by Sanofi at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hypercholesterolaemia and Mixed Dyslipidaemia, Atherosclerotic Cardiovascular Disease
- How many people
- 163 participants
- Where
- 1 siteGermany
- Study dates
- 18 Nov 2021to 16 Feb 2023
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector (MARS-NIS)
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
Read the detailed description
Study duration per participant is approximately 12 weeks
- Conditions
- Primary Hypercholesterolaemia and Mixed Dyslipidaemia, Atherosclerotic Cardiovascular Disease
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)
Measured: from baseline to week 12
Percent change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)
Measured: from baseline to week 12
Treatment acceptance assessed using the Injection Treatment Acceptance Questionnaire (ITAQ)
Measured: week 12
Secondary outcomes (2)
Number of patients with adverse events
Measured: up to 12 weeks
Number of quality defects assessed using product complaints
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start18 Nov 2021
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Hypercholesterolaemia and Mixed DyslipidaemiaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129241
- Sponsor's protocol ID
- OBS17242
- Other IDs
- U1111-1265-6221
- Acronym
- MARS
- Status last verified
- Mar 2025
- First submitted
- 15 Nov 2021
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
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.
PubMed 39875772
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector (MARS-NIS)
- ClinicalTrials.gov ID
- NCT05129241
- Acronym / sponsor ID
- MARS / OBS17242
- Conditions
- Primary Hypercholesterolaemia and Mixed Dyslipidaemia, Atherosclerotic Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Absolute change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)
Time frame: from baseline to week 12
Percent change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)
Time frame: from baseline to week 12
Treatment acceptance assessed using the Injection Treatment Acceptance Questionnaire (ITAQ)
Time frame: week 12
2 secondary outcomes
Number of patients with adverse events
Time frame: up to 12 weeks
Number of quality defects assessed using product complaints
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Results publication: PubMed 39875772Parhofer 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.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hypercholesterolaemia and Mixed Dyslipidaemia and Atherosclerotic Cardiovascular Disease, run by Sanofi at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C) (time frame: from baseline to week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05129241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.