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Double-Drug attack on cholesterol: could two be better than one?

NCT ID NCT07581808

Disease control Sponsor: University Medical Centre Ljubljana 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether combining two different cholesterol-lowering drugs (inclisiran and alirocumab) works better than using either alone. About 60 adults with high heart risk who cannot take statins will be assigned to one of three groups. The goal is to see if the combo lowers 'bad' cholesterol more effectively and safely over 9 months.

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

About 60 people

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

Started

May 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 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: * Adults aged ≥18 years * Established atherosclerotic cardiovascular disease (secondary prevention), defined as prior cardiovascular events or imaging-confirmed atherosclerosis (e.g., coronary artery disease on angiography or CT, carotid plaque on ultrasound, or peripheral arterial disease). * Eligible for PCSK9 inhibitor therapy according to national clinical criteria * Fasting LDL cholesterol ≥2.5 mmol/L and ≤5.0 mmol/L at screening * Documented statin intolerance or contraindication to statin therapy * On stable background lipid-lowering therapy (including ezetimibe if applicable) for at least 4 weeks prior to enrollment * Able and willing to provide written informed consent Exclusion Criteria: * Eligibility for PCSK9 inhibitor therapy solely based on elevated lipoprotein(a) \>1000 mg/L with LDL-C below inclusion threshold * Prior use of any PCSK9 inhibitor (alirocumab, evolocumab or inclisiran) before enrollment * Planned initiation or modification of lipid-lowering therapy during the study period * Known homozygous familial hypercholesterolemia * Active liver disease or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3× upper limit of normal * Severe renal impairment (eGFR \<30 mL/min/1.73 m²) * Active malignancy or life expectancy \<1 year * Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception * Known hypersensitivity to inclisiran, alirocumab, or any of their excipients * Participation in another interventional clinical trial within 30 days prior to enrollment * Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

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

Atherosclerotic cardiovascular disease (ascvd) 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

  • University Medical Centre Ljubljana

    RECRUITING

    Ljubljana, 1000, Slovenia

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