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New combo pill aims to crush stubborn high cholesterol

NCT ID NCT07442630

Disease control Sponsor: JW Pharmaceutical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a fixed-dose combination pill containing Pitavastatin and Ezetimibe against Pitavastatin alone in 88 people with high cholesterol and high triglycerides. Participants take the pill daily for 52 weeks. The main goal is to see how much LDL ('bad') cholesterol drops after 8 weeks, with longer-term effects on HDL and triglycerides also measured.

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 combination pill
What this could lead to
If successful, this could provide a more effective long-term option for managing high cholesterol and reducing heart disease risk.
What could go wrong
This is a Phase 4 study, so the drugs are already approved; the main uncertainties are about long-term safety and whether the combination works better than Pitavastatin alone. Side effects like muscle pain or liver issues are possible.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

88 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Nov 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.

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: * Patients with hypercholesterolemia * Patients diagnosed with metabolic syndrome or type 2 diabetes mellitus, and presenting with elevated LDL-C Exclusion Criteria: * New-onset acute cardio-cerebrovascular disease * Severe hepatic impairment * Active liver disease

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Conditions

The condition(s) this trial relates to.

Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

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

Hypercholesterolemia

Contacts and locations

Locations

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    Seoul, South Korea

More trials for these conditions

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