A Multicenter, Prospective, Phase IV, Interventional Study to Investigate the Effectiveness and Safety of Bempedoic Acid in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia in Taiwan

Launched by DAIICHI SANKYO TAIWAN LTD. · Apr 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called bempedoic acid for patients in Taiwan who have high cholesterol levels, specifically those diagnosed with primary hypercholesterolemia or mixed dyslipidemia. High cholesterol can lead to serious heart problems, and many patients aren’t able to reach their cholesterol goals even after taking other treatments. Bempedoic acid is a new type of cholesterol-lowering medication that has shown promise in previous studies, but this trial aims to gather more information specifically about its use in the Taiwanese population.

To participate in this study, you must be at least 18 years old and have been diagnosed with high cholesterol that hasn’t improved enough with other treatments. This includes patients who may not be able to tolerate statins, which are commonly used cholesterol medications. The trial will involve around 180 patients, and those who qualify can expect to take bempedoic acid under the supervision of their healthcare team. It’s important to note that this study is not yet recruiting participants, so interested individuals may need to wait for further announcements.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. At least 18 years of age
• 2. Diagnosed with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia:
• • Patients who have been on statin or statin combining with other lipid-lowering therapies\* (both under the maximum tolerated dose of statin) for at least 4 weeks, but unable to reach LDL-C goals† OR
• • Patients who are statin-intolerant or contraindicated to statin, alone or have been on other non-statin lipid-lowering therapies\* for at least 4 weeks, but unable to reach LDL-C goals†
• • \* Other lipid-lowering therapies: Ezetimibe, Cholesterol and/or bile acid, absorption inhibitors, PCSK9 inhibitors, Omega-3 fatty acids, Fibrates, or Niacin derivatives
• † LDL-C goals are defined as:
• • Patients with ASCVD or had conducted coronary revascularization procedures (e.g., PCI or CABG): LDL-C \< 70 mg/dL
• • Patients aside from the above population: LDL-C \< 100 mg/dL
• • 3. The physician intends to prescribe bempedoic acid per locally approved label (the study intends no intervention in physicians' judgement on the prescription of bempedoic acid)
• • 4. Provide written informed consent
• Exclusion Criteria:
• • 1. Concurrent participation in an interventional study (simultaneous participation in other non-interventional studies is acceptable)
• • 2. With eGFR \< 30 mL/min/1.73 m2, end-stage renal disease (ESRD) on dialysis, severe hepatic impairment (Child-Pugh C), bempedoic acid contraindications (i.e., hypersensitivity to the active substance or any of the excipients, galactose intolerance, pregnancy, breastfeeding, concomitant use with simvastatin \> 40 mg daily)