What is this study trying to find out about primary hypercholesterolemia and mixed dyslipidemia?

This study aims to understand how effective and safe the combination of bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin is in lowering LDL cholesterol in real-world patients. It helps assess how well this triple therapy works and its impact on health outcomes over one year.

Who may be eligible for this primary hypercholesterolemia or mixed dyslipidemia clinical trial?

Adults aged 18 years or older with diagnosed primary hypercholesterolemia or mixed dyslipidemia who are treated with the triple therapy combination may be eligible. Participants should not have recent PCSK9i treatments and must have a life expectancy over one year. Please review eligibility criteria for more details.

Is there any cost to participate in this primary hypercholesterolemia or mixed dyslipidemia clinical trial?

Study-related care, including monitoring and trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Age: 18Years +

All Genders

ID06686615

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

Led by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company · Updated on 2026-05-08

2000

Participants Needed

163

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the real-world use, effectiveness, and safety of triple therapy combining bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin in adults with primary hypercholesterolemia or mixed dyslipidemia. This observational study focuses on how well this combination lowers LDL cholesterol LDL-C and its safety when used in clinical practice, addressing the limited data currently available on such combination treatments. The study observes patients who have started triple therapy with bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin without administering any drugs as part of the trial. Participants will be followed for up to one year after beginning triple therapy. The study does not compare rosuvastatin and atorvastatin directly but assesses the overall impact of the triple therapy on LDL-C levels. Participants will have their LDL-C levels measured at 8 weeks and one year after starting triple therapy to evaluate effectiveness. Researchers will also track goal attainment based on guidelines, changes in laboratory values, adherence to therapy, and any adverse events. Cardiovascular events such as non-fatal heart attacks, strokes, and deaths will be monitored during the follow-up. Treatment changes and the patient journey over the year will also be recorded. The total participation time is up to one year after therapy initiation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Provided written informed consent to participate
At least 18 years of age
High or very high risk patients diagnosed with primary hypercholesterolemia or mixed dyslipidemia at start of bempedoic acid treatment
Treated with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin in any combination or simultaneously
Initiated triple therapy within 4 weeks before inclusion
Has an untreated LDL-C value available within 5 years before starting triple therapy
No contraindications to bempedoic acid, statins, or ezetimibe as assessed by physician
Not participating in any interventional study currently
Life expectancy greater than 1 year

You will not qualify if you...

Received PCSK9i monoclonal antibody treatment within 3 months before starting triple therapy
Ever received PCSK9i-siRNA treatment

Research Team

Daiichi Sankyo Contact for Clinical Trial Information

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