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

NCT07374861 | Recruiting DMC FDA Drug

• 1 other identifier: Prot. 28/2025
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  6-12-24-36 months

Secondary Outcomes (1)

• Description of safety of treatment with Bempedoic acid in a real-life Italian population

  6-12-24-36 months

Study Arms (1)

Subjects with hyperlipidaemia under Bempedoic acid treatment

Drug: Bempedoic acid

Interventions

Bempedoic acid DRUG

film-coated tablets

Subjects with hyperlipidaemia under Bempedoic acid treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Patients under Bempedoic acid treatment

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University of Naples, Department of Advanced Biomedical Sciences

Naples, Napoli, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Pasquale Perrone Filardi

CONTACT

+39081/7462224; fpperron@unina.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: November 4, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)