NCT06686615

A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Effectiveness and Safety of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia: an Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Data on the real-world use and effectiveness and safety of bempedoic acid combined with both a statin and ezetimibe in clinical practice is limited. There is an increased focus on using combination therapy to lower LDL-C.

Detailed description

The aim of the current study is to evaluate the effectiveness and safety of bempedoic acid combined with ezetimibe and either atorvastatin or rosuvastatin (hereafter defined as triple therapy) in a real-world clinical setting. No drug will be administered during this observational study. The primary objective of the study is to evaluate the effectiveness of the triple therapy in terms of LDL-C reduction at 8 weeks. The secondary objectives will include the following: * Goal attainment at 8 weeks and 1 year after start of triple therapy * Effectiveness of triple therapy in terms of LDL-C reduction at 1 year * Effectiveness of adding bempedoic acid to statin and ezetimbe at 8 weeks and 1 year * Effectiveness of adding bempedoic acid/ezetimibe FDC to statin in terms of LDL-C reduction at 8 weeks and 1 year * Changes in laboratory values at 8 weeks and 1 year after start of triple therapy * Adherence to triple therapy treatment * Collection and recording of all adverse events occurred since initiation of triple therapy * MACE-3 and MACE-4 (consisting of non-fatal MI, non-fatal stroke, CV-death, and coronary revascularization (for MACE-4 only)) during the year of follow-up * Treatment changes at LMT initiation and at triple therapy initiation * Treatment pathway from triple therapy initiation to 1-year after start of triple therapy

Conditions

• Primary Hypercholesterolemiia
• Mixed Dyslipidemia

Interventions

Type	Name	Description
DRUG	Bempedoic acid	No drug was administered in this observational study.
DRUG	Ezetimibe	No drug was administered in this observational study.
DRUG	Rosuvastatin	No drug was administered in this observational study.
DRUG	Atorvastatin	No drug was administered in this observational study.

Timeline

• Start date: 2025-02-12
• Primary completion: 2027-07-31
• Completion: 2028-01-31
• First posted: 2024-11-13
• Last updated: 2026-04-07

Locations

163 sites across 5 countries: Austria, Belgium, Germany, Italy, Spain