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Primary Hypercholesterolemia or Mixed HyperlipidemiaPhase 4CLEAR TaiwanNCT06925100

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

A Phase 4 study testing Bempedoic acid 180 mg tablet in people with Primary Hypercholesterolemia or Mixed Hyperlipidemia, run by Daiichi Sankyo at 3 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bempedoic acid 180 mg tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
3 sitesTaiwan
Study dates
1 Apr 2025to 15 Oct 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Far Eastern Memorial Hospital

    New Taipei City, 220

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: 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 - The CLEAR Taiwan Study

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.

Read more

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.

Read the detailed description

This is a multicenter, prospective, phase IV, single-arm, interventional study investigating the effectiveness and safety of bempeodoic acid in Taiwanese patients with hypercholesterolemia or mixed dyslipidemia. The study will be conducted in three medical centers in Taiwan to include approximately 180 patients with hypercholesterolemia or mixed dyslipidemia.

All enrolled patients will receive bempedoic acid 180 mg once daily for 12 weeks, with a total of 3 visits as follows: Baseline, Week 4, and Week 12; and there will be one follow-up visit at 2 to 4 weeks after discontinuation for those who discontinue the study due to adverse events. Across the study period, all patients must maintain the regimen (including medication, dose, and frequency) of their background LLT that they received before initiating bempedoic acid treatment.

Aside from bempedoic acid, LLT, study visits, and assessments, other medical procedures and prescriptions will be based on physicians' judgments per real-world clinical practice. Subjects will be continually followed up from the enrollment date until Week 12, bempedoic acid discontinuation, study discontinuation, or lost to follow-up, whichever occurs first.

Being tested
Bempedoic acid 180 mg tablet
Keywords
Taiwan, low-density lipoprotein cholesterol, primary hypercholesterolemia, bempedoic acid, mixed dyslipidemia
Medical subject headings
Hyperlipoproteinemia Type II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bempedoic acid 180 mg tabletDrug

    180 mg tablet, once daily administered for 12 weeks

Study groups in NCT06925100
Study groupRoleWhat they receive
bempedoic acidExperimental180 mg, oral, once daily for 12 weeks
Receives: Drug: Bempedoic acid 180 mg tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 weeks

Secondary outcomes (4)

  1. LDL-C goal attainment rate at Week 12

    To investigate the LDL-C goal attainment rate at Week 12, the LDL-C goal is set as follows:

    1. Patients with ASCVD or had conducted coronary revascularization procedures (e.g., PCI or CABG): Attainment rate at LDL-C < 100 mg/dL, LDL-C < 70 mg/dL, and LDL-C < 55 mg/dL
    2. Patients aside from the above population: Attainment rate at LDL-C < 100 mg/dL

    Measured: 12 weeks

  2. 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

    To investigate the percentage change from baseline in other lipid parameters (TC, apoB, HDL-C, non-HDL-C, and TG) at Week 12

    Measured: 12 weeks

  3. Percentage change from baseline in hsCRP level at Week 12

    To investigate the percentage change from baseline in hsCRP level at Week 12

    Measured: 12 weeks

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

    To assess the adverse events, adverse events of special interest (AESI), and adverse drug reactions associated with bempedoic acid

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2025
  2. Study start1 Apr 2025
  3. Primary completion15 Oct 2025
  4. Study completion15 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06925100
Sponsor's protocol ID
BA-TWMA-HLD-4001
Acronym
CLEAR Taiwan
Status last verified
Dec 2025
First submitted
6 Apr 2025
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Publications

  • Hsieh IC, Chen DY, Chu CS, Chang YY, Tzeng BH, Huang TC, Lin HH, Chuang WP, Huang CC, Yeh JK, Chu CY, Ho MY, Huang CY, Chen YW, Yang WC, Lin TH, Wu YW. Effectiveness and Safety of Bempedoic Acid in Taiwanese Patients With Hypercholesterolemia: A Pragmatic Phase 4 Study (CLEAR Taiwan Study). J Am Heart Assoc. 2026 May 19;15(10):e049917. doi: 10.1161/JAHA.126.049917. Epub 2026 May 14.

    PubMed 42134976

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bempedoic acid 180 mg tablet in people with Primary Hypercholesterolemia or Mixed Hyperlipidemia, run by Daiichi Sankyo at 3 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change from baseline in LDL-C level at Week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06925100, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

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