HypercholesterolemiaBEMPENETNCT07374861
Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy
An observational study of Hypercholesterolemia, run by Federico II University at 1 site in Italy.
Trial summary
Evaluation of adherence, persistence, and efficacy of treatment with Bempedoic acid in a real-life Italian population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Bempedoic acid
- Type of treatment
- Pill or oral medicine
- How many people
- 1,500 participants
- Where
- 1 siteItaly
- Study dates
- 4 Nov 2025to 31 Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes patients from Italy who have received Bempedoic acid as part of routine clinical management of their hyperlipidaemia, based on national reimbursement criteria at the time of enrollment.
Who may be able to join
- Patients under Bempedoic acid 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, +39081/7462224, fpperron@unina.it
About this study
Evaluation of adherence, persistence, and efficacy of treatment with Bempedoic acid in a real-life Italian population.
- Conditions
- Hypercholesterolemia
- Being tested
- Bempedoic acid
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bempedoic acidDrug
film-coated tablets
| Study group | Role | What they receive |
|---|---|---|
| Subjects with hyperlipidaemia under Bempedoic acid treatment | Not described Receives: Drug: Bempedoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of adherence to treatment with Bempedoic acid 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 efficacy of treatment with Bempedoic acid 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
Description of persistence to treatment with Bempedoic acid 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
Secondary outcomes (1)
Description of safety of treatment with Bempedoic acid 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 start4 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- NCT07374861
- Sponsor's protocol ID
- Prot. 28/2025
- Acronym
- BEMPENET
- 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
- Individual data sharing
- 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
- Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy
- ClinicalTrials.gov ID
- NCT07374861
- Acronym / sponsor ID
- BEMPENET / Prot. 28/2025
- Conditions
- Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (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 Bempedoic acid 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 Bempedoic acid treatment | – | Drug: Bempedoic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients from Italy who have received Bempedoic acid as part of routine clinical management of their hyperlipidaemia, based on national reimbursement criteria at the time of enrollment.
Key inclusion criteria (1 listed)
- Patients under Bempedoic acid 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 |
|---|---|---|
| Bempedoic acidfilm-coated tablets | Drug | Subjects with hyperlipidaemia under Bempedoic acid treatment |
Primary outcome
Description of adherence to treatment with Bempedoic acid 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 efficacy of treatment with Bempedoic acid 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).
Description of persistence to treatment with Bempedoic acid 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.
1 secondary outcome
Description of safety of treatment with Bempedoic acid 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.
- Individual participant dataSharing planned: No
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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 Hypercholesterolemia, 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 (+39081/7462224, 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 to treatment with Bempedoic acid 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; AzTrials last refreshed its copy on 2 Nov 2026.