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New drug targets hidden heart risk in people with high lp(a)

NCT ID NCT07613294

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Updated 9 times

Summary

This study tests a drug called lepodisiran in 252 adults with high levels of Lp(a), a protein linked to heart disease. Participants must have heart disease or be at risk for a first heart event. The drug is given as an injection and compared to a placebo to see if it reduces plaque in the heart's arteries over about 2 years.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 252 people

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

Started

Jun 2026

Expected to finish

Dec 2029

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

45 to 80 years

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: * Have an Lp(a) ≥175 nmol/L * Have established cardiovascular (CV) disease or are at risk for a first CV event * Have angiographic evidence of coronary artery disease on screening CCTA * If taking lipid-lowering medications, inclusive of statins or prescription strength niacin and PCSK9 inhibitors, these should be stable for 8 weeks Exclusion Criteria: * Have had a major CV event less than 60 days before measurement of the Lp(a) level used for eligibility or uncontrolled high blood pressure at screening * Have moderate to severe renal dysfunction * Have severe heart failure * Have a history of coronary artery bypass graft surgery (CABG) * Have a planned coronary angiography, percutaneous coronary intervention (PCI), coronary artery bypass graft, or valvular intervention * Have had a procedure to remove lipoproteins from the blood or received therapy specifically targeting Lp(a) * Are unable to safely undergo CCTA due to medication intolerance, contrast allergies, or anatomical/technical factors

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    58 sites in 7 countries. 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

  • AIM Research

    RECRUITING

    Merewether, 2291, Australia

  • Advara HeartCare - Burwood

    RECRUITING

    Burwood, 2134, Australia

  • Advara HeartCare - Mulgrave

    NOT_YET_RECRUITING

    Mulgrave, 3170, Australia

  • Advara HeartCare Joondalup

    RECRUITING

    Joondalup, 6027, Australia

  • Advara HeartCare Leabrook

    RECRUITING

    Leabrook, 5068, Australia

  • Alrijne Ziekenhuis, locatie Leiderdorp

    NOT_YET_RECRUITING

    Leiderdorp, 2353 GA, Netherlands

  • Bristol Royal Infirmary

    NOT_YET_RECRUITING

    Bristol, BS2 8HW, United Kingdom

  • CARE Institute - High Desert

    NOT_YET_RECRUITING

    Meridian, Idaho, 83642, United States

  • CHUAC-Complejo Hospitalario Universitario A Coruña

    RECRUITING

    A Coruña, 15001, Spain

  • Carilion Clinic

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • Cheadle Community Hospital

    NOT_YET_RECRUITING

    Cheadle, ST10 1NS, United Kingdom

  • Clinical Site Partners, LLC dba Flourish Research

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Clinitrials

    RECRUITING

    West Perth, 6005, Australia

  • Core Research Group

    NOT_YET_RECRUITING

    Brisbane, 4064, Australia

  • EFERTUS healthcare s.r.o.

    RECRUITING

    Brno, 615 00, Czechia

  • Eastside Research Associates

    RECRUITING

    Redmond, Washington, 98052, United States

  • Fakultni Nemocnice u sv. Anny v Brne

    RECRUITING

    Brno, 60200, Czechia

  • Fakultni Nemocnice u sv. Anny v Brne

    RECRUITING

    Brno, 656 91, Czechia

  • FutureMeds - Birmingham

    RECRUITING

    Birmingham, B21 9RY, United Kingdom

  • FutureMeds Teesside - Middlefield Centre

    RECRUITING

    Stockton-on-Tees, TS19 8PE, United Kingdom

  • Futuremeds-Newcastle

    RECRUITING

    Newcastle, NE6 1SG, United Kingdom

  • Heart and Vascular Research at WellSpan Health

    RECRUITING

    York, Pennsylvania, 17403, United States

  • Hospital Clinico San Carlos

    NOT_YET_RECRUITING

    Madrid, 28040, Spain

  • Hospital General Universitario de Valencia

    NOT_YET_RECRUITING

    Valencia, 46014, Spain

  • Hospital Insular de Gran Canaria

    RECRUITING

    Las Palmas de Gran Canaria, 35016, Spain

  • Hospital Quiron Barcelona

    RECRUITING

    Barcelona, 08023, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Reina Sofia

    RECRUITING

    Córdoba, 14004, Spain

  • Hospital Universitario Virgen Del Rocio

    NOT_YET_RECRUITING

    Seville, 41013, Spain

  • Hospital Universitario Virgen Macarena

    NOT_YET_RECRUITING

    Seville, 41009, Spain

  • Inpatient Research Clinic

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • Intermountain Medical Center

    NOT_YET_RECRUITING

    Murray, Utah, 84107, United States

  • Jacksonville Center for Clinical Research

    RECRUITING

    Jacksonville, Florida, 32216, United States

  • Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care

    RECRUITING

    Fort Lauderdale, Florida, 33312, United States

  • Lincoln County Hospital

    NOT_YET_RECRUITING

    Lincoln, LN2 5QY, United Kingdom

  • Lister Hospital

    RECRUITING

    Stevenage, SG1 4AB, United Kingdom

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    RECRUITING

    Torrance, California, 90502, United States

  • Massachusetts General Hospital

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02114, United States

  • Medisch Spectrum Twente

    NOT_YET_RECRUITING

    Enschede, 7512 KZ, Netherlands

  • Merritt Island Medical Research, LLC

    RECRUITING

    Merritt Island, Florida, 32952, United States

  • Nightingale Research

    RECRUITING

    Adelaide, 5000, Australia

  • Parc de Salut Mar - Hospital del Mar

    RECRUITING

    Barcelona, 08003, Spain

  • Profound Research LLC

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Royal Lancaster Infirmary

    NOT_YET_RECRUITING

    Lancaster, LA1 4RP, United Kingdom

  • Semmelweis University

    NOT_YET_RECRUITING

    Budapest, 1122, Hungary

  • Sheffield Teaching Hospitals NHS Foundation Trust

    NOT_YET_RECRUITING

    Sheffield, S5 7AU, United Kingdom

  • Szabolcs Szatmár Bereg Vármegyei Oktatókórház

    NOT_YET_RECRUITING

    Nyíregyháza, 4400, Hungary

  • The John Radcliffe Hospital

    NOT_YET_RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • Top Moravia Health

    RECRUITING

    Brno, 61500, Czechia

  • UCSD - Altman Clinical and Translational Research Institute (ACTRI)

    NOT_YET_RECRUITING

    La Jolla, California, 92037-7410, United States

  • USC Clinical Trials Brisbane (South Bank)

    RECRUITING

    South Brisbane, 4101, Australia

  • University of the Sunshine Coast (UniSC) Clinical Trials - Birtinya

    RECRUITING

    Birtinya, 4575, Australia

  • Valley Clinical Trials, Inc.

    RECRUITING

    Northridge, California, 91325, United States

  • Vector Clinical Trials

    RECRUITING

    Las Vegas, Nevada, 89128, United States

  • VieCuri Medisch Centrum, locatie Venlo

    NOT_YET_RECRUITING

    Venlo, 5912 BL, Netherlands

  • Virginia Heart

    NOT_YET_RECRUITING

    Falls Church, Virginia, 22042, United States

  • Ziekenhuis St. Jansdal

    NOT_YET_RECRUITING

    Harderwijk, 3844 DG, Netherlands

  • Óbudai Egészségügyi Centrum

    RECRUITING

    Budapest, 1036, Hungary

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