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New combo pill for high cholesterol tested on thousands

NCT ID NCT06314919

Disease control Sponsor: Boryung Pharmaceutical Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing a fixed-dose combination of two cholesterol-lowering drugs, pitavastatin and ezetimibe, in over 8,600 people with high cholesterol or mixed lipid disorders. The goal is to see how well the combo works and how safe it is in real-world conditions, outside of a strict research setting. Participants are already on statins or ezetimibe and are switching to the combo pill.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pitavastatin and Ezetimibe (fixed-dose combination)
What this could lead to
If successful, this could confirm that the fixed-dose combination is effective and safe for managing high cholesterol in everyday practice.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It also focuses on cholesterol levels, not long-term health outcomes like heart attacks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 8,606 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who require administration of a fixed-dose combination of pitavastatin/ezetimibe for the treatment of primary hypercholesterolemia or mixed dyslipidemia

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Those who taking statins or statins and ezetimibe in addition to dietary and exercise therapy for primary hypercholesterolemia or mixed hyperlipidemia * Those who are judged to need administration of a fixed-dose combination of pitavastatin/ezetimibe for change of statin's formulation or change of statin's dose, addition of ezetimibe Exclusion Criteria: * Those who are taking a fixed-dose combination of pitavastatin/ezetimibe at study enrollment * Those with hypersensitivity reactions or relevant medical history to pitavastatin or ezetimibe * Those who have been administered an investigational product within 12 weeks of the enrollment date or are planning to participate in another clinical trial during this study participation period.

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Conditions

The condition(s) this trial relates to.

hyperlipidemia, familial combined, LPL related

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mixed dyslipidemia Primary hypercholesterolemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ewha Womans University Seoul Hospital

    RECRUITING

    Seoul, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.