A Study to Investigate the Effectiveness and Safety of Bempedoic Acid in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia in Taiwan

NCT06925100 | Completed Phase 4

• 1 other identifier: BA-TWMA-HLD-4001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

Brief Summary

Cardiovascular disease (CVD) is a chronic non-communicable disease among the most common causes of death worldwide. Substantial reductions in risks of CVD can be achieved through the management of modifiable risk factors, particularly low-density lipoprotein cholesterol (LDL-C). However, only 18.3% of high-risk primary prevention patients and 20.7% of secondary prevention patients achieved the treatment goals based on the 2019 ESC guidelines. Similar trends were reported by the latest European multinational observational SANTORINI study. These real-world evidence data indicate the suboptimal implementation of ESC/EAS 2019 guidelines on LDL-C, particularly the low use of combinational lipid-lowering therapy (LLT), leading to a substantial proportion of patients remaining at high residual risk of ASCVD events. Bempedoic acid, a first-in-class novel nonstatin lipid-lowering agent, was approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2020 for the treatment of primary hypercholesterolemia. Bempedoic acid inhibits cholesterol biosynthesis through the inhibition of adenosine triphosphate-citrate lyase, an upstream enzyme of 3-hydroxy-3-methylglutaryl-coenzyme A reductase. The unique hepatic activation of bempedoic acid results in limited exposure to skeletal muscle, which prevents musculoskeletal-related adverse events. Phase II and III RCTs have demonstrated efficacy with adequate safety data of bempedoic acid as mono- or combination therapy with statins and ezetimibe. The CLEAR outcomes trial demonstrated the benefit of bempedoic acid in lowering the risks of major adverse cardiovascular events in statin-intolerant patients. However, there is limited data on bempedoic acid treatment in East Asian subjects and no data in the Taiwanese population, despite modeling data from large studies indicating the potential for no ethnic differences. To investigate the effectiveness and safety of bempedoic acid in a Taiwanese population, this phase IV study is conducted to examine the treatment outcomes in approximately 180 patients using bempedoic acid in Taiwan.

Conditions

Primary Hypercholesterolemia or Mixed Hyperlipidemia

Keywords

Taiwan; low-density lipoprotein cholesterol; primary hypercholesterolemia; bempedoic acid; mixed dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Percentage change from baseline in LDL-C level at Week 12

  To investigate the percentage change from baseline in LDL-C level at Week 12

  12 weeks

Secondary Outcomes (4)

• LDL-C goal attainment rate at Week 12

  12 weeks

• Percentage change from baseline in other lipid parameters (total cholesterol [TC], apolipoprotein B [apoB], high-density lipoprotein cholesterol [HDL-C], non-HDL-C, and triglycerides [TGs]) at Week 12

  12 weeks

• Percentage change from baseline in hsCRP level at Week 12

  12 weeks

• Adverse events, adverse events of special interest (AESI), and adverse drug reactions associated with bempedoic acid

  12 weeks

Other Outcomes (2)

• Percentage change from baseline in lipoprotein A [Lp(a)] at Week 12

  12 weeks

• Change from baseline in HbA1c level at Week 12

  12 weeks

Study Arms (1)

bempedoic acid

EXPERIMENTAL

180 mg, oral, once daily for 12 weeks

Drug: Bempedoic acid 180 mg tablet

Interventions

Bempedoic acid 180 mg tablet DRUG

180 mg tablet, once daily administered for 12 weeks

bempedoic acid

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age
• 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
• 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)
• Provide written informed consent

You may not qualify if:

• Concurrent participation in an interventional study (simultaneous participation in other non-interventional studies is acceptable)
• 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)

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (3)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

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

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 13, 2025
• Study Start: April 1, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

TW (3)