Hyper-low-density Lipoprotein (LDL) CholesterolemiaPhase 3NCT05687071

A Long-term Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia

A Phase 3 study testing 180mg of ETC-1002(bempedoic acid) in people with Hyper-low-density Lipoprotein (LDL) Cholesterolemia, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

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

A Multicenter, Open-label Study to assess the safety and efficacy of ETC-1002 at 180 mg administered for 52 weeks in patients with hyper-LDL cholesterolemia Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Hyper-low-density Lipoprotein (LDL) Cholesterolemia
What is being tested?: 180mg of ETC-1002(bempedoic acid)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 1 siteJapan
Study dates: 27 Feb 2023to 2 Nov 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with inadequate response to statins or who have difficulty in treatment with statins as defined below [Inadequate response to statins] Patients with hyper-LDL cholesterolemia who are currently taking or have previously taken statins[and other lipid-modifying therapies(LMTs) if needed] and cannot achieve the lipid management goals of LDL-C [Difficulty in treatment with statins] Patients with hyper-LDL cholesterolemia for whom safety problems have occurred while taking at least one type of statin, and who experienced resolution of the problems after discontinuation or dose reduction, or of those patients who have a history of statin administration and who are judged to have concerns of safety problems associated with the administration or dose increase of statins and who cannot achieve the lipid management goals of LDL-C. Patients must be on the lowest or under the dosage of the approved dose of statin and/or on stable LMT(s).
Patients with fasting TG levels of <400 mg/dL at screening
Other protocol specific inclusion criteria may apply

Who cannot join

Females who are pregnant or breast-feeding or who have a positive pregnancy test (urine) result at screening or baseline visits
Patients with homozygous familial hypercholesterolemia (HoFH)
Patients who currently have or who have had within the past 3 months prior to screening any cardiovascular diseases, or those who have developed any cardiovascular diseases during the screening
Uncontrolled hypertension, defined as sitting systolic blood pressure after resting 5 minutes of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg at screening
Patients with uncontrolled and serious hematologic or coagulation disorders or with hemoglobin of <10.0 g/dL at screening
Patients with uncontrolled diabetes with HbA1c of ≥9% at screening

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Patients with uncontrolled hypothyroidism with thyroid-stimulating hormone (TSH) of >1.5 × ULN at screening
Patients with liver disease or dysfunction, including:
Positive serology for hepatitis B surface antigen (HBsAg) or a positive hepatitis C virus (HCV) antibody test at screening
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥3 × ULN or total bilirubin of ≥2 × ULN at screening
Patients with creatine kinase (CK) of >3 × ULN at screening
Patients with a history or current renal dysfunction, nephritic syndrome, or nephritis, and with estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73 m2 at screening
Other protocol specific exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

Japan1 site

Rinku General Medical Center
Izumisano

Other trials in Japan

About this study

Official title: A Multicenter, Open-label, Uncontrolled, Long-term Trial to Assess the Safety and Efficacy of ETC-1002 in Patients With Hyper-LDL Cholesterolemia

A Multicenter, Open-label Study to assess the safety and efficacy of ETC-1002 at 180 mg administered for 52 weeks in patients with hyper-LDL cholesterolemia

Conditions: Hyper-low-density Lipoprotein (LDL) Cholesterolemia
Being tested: 180mg of ETC-1002(bempedoic acid)

What participants receive

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

180mg of ETC-1002(bempedoic acid)Drug
180mg, tablet, once daily, for 52 weeks

Study groups in NCT05687071
Study group	Role	What they receive
ETC-1002 180mg	Experimental	Not described Receives: Drug: 180mg of ETC-1002(bempedoic acid)

What is being measured

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

Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)
Measured: From baseline to week 52
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100.
Measured: Baseline, week52

Secondary outcomes (6)

Percent Change in Non-HDL Cholesterol From Baseline to Week 52
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100.
Measured: Baseline, week52
Percent Change in Total Cholesterol From Baseline to Week 52
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100.
Measured: Baseline, week52
Percent Change in Apolipoprotein B From Baseline to Week 52
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100.
Measured: Baseline, week52
Percent Change in High Sensitivity C Reactive Protein From Baseline to Week 52
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100.
Measured: Baseline, week52
Percent Change in Hemoglobin A1c From Baseline to Week 52
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100.
Measured: Baseline, week52
Proportion of Subjects Whose LDL-C Value Achieved the Lipid Management Goals Based on Risk Assessment at Week 52
The proportion of subjects whose LDL-C value achieves the lipid management goal at Week 52.
Measured: Baseline, week52

Timeline

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

27 Feb 20232 Nov 2024

First posted17 Jan 2023
Study start27 Feb 2023
Primary completion5 Oct 2024
Study completion2 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hyper-low-density Lipoprotein (LDL) CholesterolemiaStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05687071
Sponsor's protocol ID: 346-102-00003
Status last verified: Feb 2026
First submitted: 4 Jan 2023
Last updated: 20 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-label, Uncontrolled, Long-term Trial to Assess the Safety and Efficacy of ETC-1002 in Patients With Hyper-LDL Cholesterolemia
ClinicalTrials.gov ID: NCT05687071
Acronym / sponsor ID: 346-102-00003
Conditions: Hyper-low-density Lipoprotein (LDL) Cholesterolemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 27 Feb 2023 (actual)
Primary completion: 5 Oct 2024 (actual)
Study completion: 2 Nov 2024 (actual)
First posted: 17 Jan 2023 (actual)
Results: Posted 20 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A Multicenter, Open-label Study to assess the safety and efficacy of ETC-1002 at 180 mg administered for 52 weeks in patients with hyper-LDL cholesterolemia

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ETC-1002 180mg	Experimental	Drug: 180mg of ETC-1002(bempedoic acid)

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with inadequate response to statins or who have difficulty in treatment with statins as defined below [Inadequate response to statins] Patients with hyper-LDL cholesterolemia who are currently taking or have previously taken statins[and other lipid-modifying therapies(LMTs) if needed] and cannot achieve the lipid management goals of LDL-C [Difficulty in treatment with statins] Patients with hyper-LDL cholesterolemia for whom safety problems have occurred while taking at least one type of statin, and who experienced resolution of the problems after discontinuation or dose reduction, or of those patients who have a history of statin administration and who are judged to have concerns of safety problems associated with the administration or dose increase of statins and who cannot achieve the lipid management goals of LDL-C. Patients must be on the lowest or under the dosage of the approved dose of statin and/or on stable LMT(s).
Patients with fasting TG levels of <400 mg/dL at screening
Other protocol specific inclusion criteria may apply

Key exclusion criteria (13 listed)

Females who are pregnant or breast-feeding or who have a positive pregnancy test (urine) result at screening or baseline visits
Patients with homozygous familial hypercholesterolemia (HoFH)
Patients who currently have or who have had within the past 3 months prior to screening any cardiovascular diseases, or those who have developed any cardiovascular diseases during the screening
Uncontrolled hypertension, defined as sitting systolic blood pressure after resting 5 minutes of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg at screening
Patients with uncontrolled and serious hematologic or coagulation disorders or with hemoglobin of <10.0 g/dL at screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
180mg of ETC-1002(bempedoic acid)180mg, tablet, once daily, for 52 weeks	Drug	ETC-1002 180mg

Primary outcome

Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)
Time frame: From baseline to week 52
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52
Time frame: Baseline, week52
Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100.

6 secondary outcomes

Percent Change in Non-HDL Cholesterol From Baseline to Week 52
Time frame: Baseline, week52
Percent Change in Total Cholesterol From Baseline to Week 52
Time frame: Baseline, week52
Percent Change in Apolipoprotein B From Baseline to Week 52
Time frame: Baseline, week52
Percent Change in High Sensitivity C Reactive Protein From Baseline to Week 52
Time frame: Baseline, week52
Percent Change in Hemoglobin A1c From Baseline to Week 52
Time frame: Baseline, week52
Proportion of Subjects Whose LDL-C Value Achieved the Lipid Management Goals Based on Risk Assessment at Week 52
Time frame: Baseline, week52

Results and safety

Results posted to the registry on 20 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ETC-1002 180 mg	130	122

Primary outcome: Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)

Time frame: From baseline to week 52. Count of participants. Unit: Participants

Measure	ETC-1002 180 mg n = 130
Value	109

Population analysed: Safety Analysis Set consisted of subjects who received at least one dose of the IMP during the treatment period.

Primary outcome: Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52

Time frame: Baseline, week52. Mean (Standard Deviation). Unit: Percent Change

Measure	ETC-1002 180 mg n = 122
Value	-21.55 (18.727)

Population analysed: Efficacy Analysis Set consisted of subjects who received at least one dose of the IMP during the treatment period, and who have LDL-C measurements at baseline and at one or more time points after administration of the IMP during the treatment period. Efficacy sample consisted of all participants with both baseline and observation at each visit of the given parameter.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ETC-1002 180 mg	8 of 130 (6.2%)	73 of 130 (56.2%)	0 of 130

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Takehisa Matsumaru study director

Otsuka Pharmaceutical Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 180mg of ETC-1002(bempedoic acid) in people with Hyper-low-density Lipoprotein (LDL) Cholesterolemia, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

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 3 inclusion and 13 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 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) (time frame: From baseline to week 52). The study lists 2 primary outcomes in all. 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 NCT05687071.

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 20 Feb 2026.