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Evaluating the effectiveness of bempedoic acid with ezetimibe and statins for cholesterol management

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

Daiichi Sankyo · NCT06686615

This study is testing if a combination of bempedoic acid, ezetimibe, and statins can help people with high cholesterol lower their LDL levels and stick to their treatment over time.

Quick facts

Study typeObservational
Enrollment2000 (estimated)
Ages18 Years and up
SexAll
SponsorDaiichi Sankyo (industry)
Locations163 sites (Braunau am Inn and 162 other locations)
Trial IDNCT06686615 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness and safety of a combination therapy involving bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin in patients with primary hypercholesterolemia or mixed dyslipidemia. The study will evaluate LDL-C reduction at 8 weeks and 1 year, along with goal attainment and adherence to the therapy. No drugs will be administered during the study, as it focuses on real-world clinical practice data. Adverse events and changes in laboratory values will also be monitored throughout the study period.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with documented primary hypercholesterolemia or mixed dyslipidemia who are at high or very high risk.

Not a fit: Patients who do not have primary hypercholesterolemia or mixed dyslipidemia, or those not at high risk, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective cholesterol management strategies for patients at high risk.

How similar studies have performed: Other studies have explored similar combination therapies, showing promising results in LDL-C reduction, but this specific combination is being evaluated in a real-world setting.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Written informed consent to participate
2. At least 18 years of age
3. High and very high risk patients as assessed by the physician suffering from documented primary hypercholesterolemia or mixed dyslipidemia at start of bempedoic acid treatment
4. Patients treated with:

   * bempedoic acid added to ezetimibe and rosuvastatin or atorvastatin,
   * bempedoic acid plus ezetimibe added to rosuvastatin or atorvastatin,
   * bempedoic acid plus atorvastatin or rosuvastatin added to ezetimibe
   * initiation of bempedoic acid, ezetimibe, and atorvastatin or rosuvastatin simultaneously

6\) Initiation of triple therapy within a maximum of four weeks prior to inclusion 7) An untreated LDL-C value must be available within 5 years prior to the start of the triple therapy. Untreated means that the LDL-C value is not influenced by any lipid lowering therapy at the time of blood collection. Time window for not being treated as specified in the protocol.

8\) No contraindications exist according to the SmPC of bempedoic acid, the respective statin and ezetimibe as per physicians' assessment 9) No concurrent participation in an interventional study (simultaneous participation in other non-interventional studies is possible) 10) Life expectancy \> 1 -year

Key Exclusion Criteria:

1. Patients who have received PCSK9i monoclonal antibody treatment in the last 3 months before the start of the triple therapy exposure
2. Patients who have ever received PCSK9i-siRNA treatment

Where this trial is running

Braunau am Inn and 162 other locations

+113 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Primary Hypercholesterolemiia, Mixed Dyslipidemia, Primary hypercholesterolemia, Mixed dyslipidemia

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.