HypercholesterolaemiaALINETNCT07375225
Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy
An observational study of Hypercholesterolaemia, run by Federico II University at 1 site in Italy.
Trial summary
Evaluation of adherence, persistence and efficacy of treatment with alirocumab 300 mg in a real-life Italian population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypercholesterolaemia
- What is being tested?
- Praluent (Alirocumab)
- Type of treatment
- Injection or infusion
- How many people
- 1,500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2024to 1 Dec 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes patients from Italy, who have received alirocumab 300mg as part of routine clinical management of their hyperlipidaemia at time of enrollment, based on national reimbursement criteria.
Who may be able to join
- Patients under alirocumab 300mg treatment.
Who cannot join
- Age < 18 years o > 80 years;
- Patients who refuse to participate and to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Federico II University of Naples, Department of Advanced Biomedical Sciences
Naples, Napoli, 80131
Pasquale Perrone Filardi, +390817462224, fpperron@unina.it
About this study
Official title: Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy - The ALINET Registry
Evaluation of adherence, persistence and efficacy of treatment with alirocumab 300 mg in a real-life Italian population.
- Conditions
- Hypercholesterolaemia
- Being tested
- Praluent (Alirocumab)
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Praluent (Alirocumab)Drug
Alirocumab 300 mg injection
| Study group | Role | What they receive |
|---|---|---|
| Subjects with hyperlipidaemia under Alirocumab 300 mg treatment. | Subjects with hyperlipidaemia Receives: Drug: Praluent (Alirocumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of adherence of treatment with alirocumab 300mg in a real-life Italian population.
Adherence will be assessed in terms of Medical Possession Ratio (MPR) which is defined as the ratio between the treatment units dispensed during the treatment period and the duration of the treatment period itself.
Measured: 6-12-24-36 months
Description of persistence of treatment with alirocumab 300mg in a real-life Italian population.
Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.
Measured: 6-12-24-36 months
Description of efficacy of treatment with alirocumab 300mg in a real-life Italian population.
Efficacy of treatment will be evaluated as a change in the LDL (deltaLDL) value from the start of treatment (percentage and absolute value).
Measured: 6-12-24-36 months
Secondary outcomes (1)
Description of safety of treatment with alirocumab 300mg in a real-life Italian population.
Safety will be evaluated in terms of adverse reactions or intolerance to the drug.
Measured: 6-12-24-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Dec 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolaemiaStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pasquale Perrone Filardi, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375225
- Sponsor's protocol ID
- Prot. 28/2024
- Acronym
- ALINET
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy - The ALINET Registry
- ClinicalTrials.gov ID
- NCT07375225
- Acronym / sponsor ID
- ALINET / Prot. 28/2024
- Conditions
- Hypercholesterolaemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 29 Jan 2026 (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.
Evaluation of adherence, persistence and efficacy of treatment with alirocumab 300 mg in a real-life Italian population.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with hyperlipidaemia under Alirocumab 300 mg treatment. | – | Drug: Praluent (Alirocumab)Subjects with hyperlipidaemia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients from Italy, who have received alirocumab 300mg as part of routine clinical management of their hyperlipidaemia at time of enrollment, based on national reimbursement criteria.
Key inclusion criteria (1 listed)
- Patients under alirocumab 300mg treatment.
Key exclusion criteria (2 listed)
- Age < 18 years o > 80 years;
- Patients who refuse to participate and to sign informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Praluent (Alirocumab)Alirocumab 300 mg injection | Drug | Subjects with hyperlipidaemia under Alirocumab 300 mg treatment. |
Primary outcome
Description of adherence of treatment with alirocumab 300mg in a real-life Italian population.
Time frame: 6-12-24-36 months
Adherence will be assessed in terms of Medical Possession Ratio (MPR) which is defined as the ratio between the treatment units dispensed during the treatment period and the duration of the treatment period itself.
Description of persistence of treatment with alirocumab 300mg in a real-life Italian population.
Time frame: 6-12-24-36 months
Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.
Description of efficacy of treatment with alirocumab 300mg in a real-life Italian population.
Time frame: 6-12-24-36 months
Efficacy of treatment will be evaluated as a change in the LDL (deltaLDL) value from the start of treatment (percentage and absolute value).
1 secondary outcome
Description of safety of treatment with alirocumab 300mg in a real-life Italian population.
Time frame: 6-12-24-36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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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.
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 Hypercholesterolaemia, run by Federico II University at 1 site in Italy.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 29 Jan 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pasquale Perrone Filardi (+390817462224, fpperron@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of adherence of treatment with alirocumab 300mg in a real-life Italian population. (time frame: 6-12-24-36 months). 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?
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 29 Jan 2026.