CClinicalTrials.gg
RecruitingNCT07375225ALINETUpdated Jan 29, 2026

Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy

An observational study in Hypercholesterolaemia, sponsored by Federico II University. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by Federico II University · Observational

Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
1,500
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Evaluation of adherence, persistence and efficacy of treatment with alirocumab 300 mg in a real-life Italian population.

02

Conditions studied

  • Hypercholesterolaemia
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

- Patients under alirocumab 300mg treatment.

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years o > 80 years;
  • Patients who refuse to participate and to sign informed consent.
04

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
1,500 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • Subjects with hyperlipidaemia under Alirocumab 300 mg treatment.

    Subjects with hyperlipidaemia

    Drug: Praluent (Alirocumab)

Interventions

  • DrugPraluent (Alirocumab)

    Alirocumab 300 mg injection

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6-12-24-36 months

  2. 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.

    Time frame: 6-12-24-36 months

  3. 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).

    Time frame: 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.

    Time frame: 6-12-24-36 months

06

Study locations

1 of 1 sites recruiting
  • Federico II University of Naples, Department of Advanced Biomedical Sciences
    Naples, Napoli 80131, Italy
    Recruiting
07

Registry details

Key details

Study ID
NCT07375225
Lead sponsor
Federico II University
Responsible party
Pasquale Perrone Filardi (Professor, Federico II University) — Principal investigator
First posted
Jan 29, 2026
Start date
Dec 1, 2024
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Jan 29, 2026

Study contacts

Pasquale Perrone Filardi
Contact
fpperron@unina.it
+390817462224

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion