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AzTrials

Healthy SubjectsPhase 1NCT07235189

A Study Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Atorvastatin

A Phase 1 study testing Bempedoic acid, Ezetimibe and Atorvastatin in people with Healthy Subjects, run by Daiichi Sankyo at 1 site in Portugal.

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

Monotherapies for lowering LDL-C often do not achieve target lipid levels because they act on a single pathway, which may be insufficient in patients with high cardiovascular risk or complex lipid profiles. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
Bempedoic acid, Ezetimibe and Atorvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 sitePortugal
Study dates
28 Oct 2025to 28 Jan 2026
Phase
Phase 1
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 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

A participant is eligible for the study if he/she fulfills all of the following inclusion criteria:

  1. Healthy male and female participants ≥18 and ≤60 years, at the time of signing the informed consent.
  2. Body mass index (BMI) ≥18.5 and ≤30.0 kg/m^2.
  3. Female participants of childbearing potential agree to undergo pregnancy tests, and if with a non-vasectomized nor infertile male partner, agree to use an appropriate method of contraception (i.e., abstinence, hormonal, intrauterine device, bilateral tubal occlusion).
  4. No clinically relevant diseases captured in medical history.
  5. No clinically relevant abnormalities on physical examination.
  6. No clinically relevant abnormalities on vital signs.
  7. No clinically relevant abnormalities on 12-lead electrocardiogram (ECG).
  8. No clinically relevant abnormalities on clinical laboratory tests.
  9. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) above the upper limit of normal range (ULN).
  10. Estimated renal creatinine clearance (CrCl) above the lower limit of normal range, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average body surface area of 1.73 m^2.
  11. Willingness to accept and comply with all study procedures and restrictions.
  12. Non-smoker or ex-smoker (i.e., someone who abstained from using tobacco- or nicotine-containing products for at least 3 months prior to Screening).
  13. Ability to comprehend and willingness to freely sign the informed consent.

A participant is not eligible for the study at Screening if he/she fulfills any of the exclusion criteria as specified in the protocol.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Research Site

    Porto, 4250-449

Other trials in Portugal

About this study

Official title: A Randomized, Single-Center, Open-Label, Single-Dose, 4-Period, 2-Sequence, Fully Replicate Crossover Study To Assess The Bioequivalence Of A Test Fixed Dose Combination Product Versus The Co-Administered Individual Reference Products Containing Bempedoic Acid 180 MG, Ezetimibe 10 mg And Atorvastatin 40 mg In Healthy Participants

Monotherapies for lowering LDL-C often do not achieve target lipid levels because they act on a single pathway, which may be insufficient in patients with high cardiovascular risk or complex lipid profiles. Triple combination therapies, targeting multiple mechanisms of cholesterol metabolism simultaneously, have demonstrated superior LDL-C reduction and better achievement of guideline recommended LDL-C goals. Additionally, combining treatments into a single regimen can improve patient adherence and compliance, further enhancing clinical outcomes. This study will test the bioequivalence of a test fixed dose combination (FDC) vs the coadministration of individual tablets.

Being tested
Bempedoic acid, Ezetimibe, Atorvastatin
Keywords
Healthy Subjects, Bioequivalence

What participants receive

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

  • Bempedoic acidDrug

    Also called Nilemdo®

    180 mg film coated tablet administered individually or as FDC

    (Component of FDC)

  • EzetimibeDrug

    Also called Ezetrol®

    10 mg tablet administered individually or as FDC

    (Component of FDC)

  • AtorvastatinDrug

    Also called Sortis®

    40 mg tablet administered individually or as FDC

    (Component of FDC)

Study groups in NCT07235189
Study groupRoleWhat they receive
Test FormulationExperimentalHealthy participants who are randomized to receive the fixed dose triplet combination with bempedoic acid 180 mg/ezetimibe 10 mg/atorvastatin 40 mg (test formulation).
Receives: Drug: Bempedoic acid; Drug: Ezetimibe; Drug: Atorvastatin
Reference FormulationActive comparatorHealthy participants who are randomized to receive co-administration of bempedoic acid 180 mg + ezetimibe 10 mg + atorvastatin 40 mg (reference formulation).
Receives: Drug: Bempedoic acid; Drug: Ezetimibe; Drug: Atorvastatin

What is being measured

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

  1. Pharmacokinetic Parameter Area Under the Curve (AUC)

    Area under the curve (AUC) from time of dosing (t=0h) to time 72 hours (AUC72h) or AUC from time of dosing (t=0h) to the time of last measurable (non-zero) concentration (AUClast) will be assessed using noncompartmental methods.

    Measured: Pre-dose (t=0h), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose

  2. Maximum Observed Concentration (Cmax)

    Maximum observed concentration will be assessed.

    Measured: Pre-dose (t=0h), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose

Secondary outcomes (6)

  1. Pharmacokinetic Parameters (AUCinf)

    AUC from time of dosing (t=0h) extrapolated to infinity (AUCinf) will be assessed using noncompartmental methods.

    Measured: Pre-dose (t=0h), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose

  2. Pharmacokinetic Parameters (AUClast/AUCinf)

    AUClast/AUCinf will be assessed using noncompartmental methods.

    Measured: Pre-dose (t=0h), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose

  3. Pharmacokinetic Parameter Time to Reach Maximum Observed Concentration (Tmax)

    Time to reach maximum observed concentration (Tmax) will be assessed.

    Measured: Pre-dose (t=0h), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose

  4. Pharmacokinetic Parameter Terminal Half-life (t1/2)

    Terminal half-life (t1/2) will be assessed using noncompartmental methods.

    Measured: Pre-dose (t=0h), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose

  5. Pharmacokinetic Parameter First Order Rate Constant Associated With The Terminal Portion of the Concentration-Time Curve (Kel)

    First order rate constant associated with the terminal portion of the concentration-time curve (Kel) was assessed using noncompartmental methods.

    Measured: Pre-dose (t=0h), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose

  6. Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)

    AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA).

    Measured: Baseline to end of study, approximately 82 days

Timeline

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

  1. First posted19 Nov 2025
  2. Study start28 Oct 2025
  3. Primary completion28 Jan 2026
  4. Study completion28 Jan 2026

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07235189
Sponsor's protocol ID
DSE-BMP-0001-CIS-MA
Other IDs
2024-519849-29-00
Status last verified
Jan 2026
First submitted
14 Nov 2025
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bempedoic acid, Ezetimibe and Atorvastatin in people with Healthy Subjects, run by Daiichi Sankyo at 1 site in Portugal.

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

Who may be eligible to take part?

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 2 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 Portugal. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Pharmacokinetic Parameter Area Under the Curve (AUC) (time frame: Pre-dose (t=0h), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose). 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 NCT07235189.

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 2 Feb 2026.

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