CClinicalTrials.gg
RecruitingNCT06287177CHOLINETUpdated Jan 22, 2026

Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy

An observational study in Hypercholesterolemia, sponsored by Federico II University. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by Federico II University · Observational

From the registry’s dates

  • Started Nov 2022; still recruiting 3 years 11 months later.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
3,000
Ages
18 Years and older
Sex
All
01

Study summary

Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population

02

Conditions studied

  • Hypercholesterolemia
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 110 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 800 across 185 observational studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Study population

The study population includes patients from Italy, who have received Inclisiran as part of routine clinical management of their hyperlipidaemia, based on national reimbursement criteria, at time of enrollment

Inclusion criteria

  • Patients under Inclisiran treatment

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years o > 80 years
  • Patients who refuse to participate and to sign informed consent
05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
3,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Subjects with hyperlipidaemia under Inclisiran treatment

    Drug: Inclisiran

Interventions

  • DrugInclisiran

    Injection

06

What researchers measure

Primary outcomes

  1. Description of adherence to treatment with Inclisiran 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: at 3 months and every 6 months thereafter

  2. Description of persistence to treatment with Inclisiran in a real-life Italian population

    Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.

    Time frame: at 3 months and every 6 months thereafter

  3. Description of efficacy of treatment with Inclisiran 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). The deltaLDL will be calculated as an overall (mean and median value), by type of prevention (primary and secondary), by type of basic therapy, by demographic variables (age, sex, geographic origin, basal LDL levels) and by type of prescriber (hospital or territorial).

    Time frame: at 3 months and every 6 months thereafter

07

Study locations

1 of 1 sites recruiting
  • Federico II University of Naples, Department of Advanced Biomedical Sciences
    Naples, 80131, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06287177
Lead sponsor
Federico II University
Responsible party
Pasquale Perrone Filardi (Professor, Federico II University) — Principal investigator
First posted
Feb 29, 2024
Start date
Nov 1, 2022
Primary completion
Feb 29, 2024
Completion
Nov 1, 2030 (estimated)
Last update
Jan 22, 2026

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.

No contact was published for this record. The registry link below has the sponsor’s details.

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