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New drug olpasiran targets artery plaque in High-Risk heart patients

NCT ID NCT07293260

Disease control Sponsor: Amgen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial tests olpasiran, a drug that lowers lipoprotein(a), a genetic risk factor for heart disease. About 406 adults with stable heart disease and high Lp(a) will receive either olpasiran or a placebo. The main goal is to see if olpasiran reduces non-calcified plaque in the arteries after 72 weeks, as measured by CT scans.

What this could mean

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

Active substance
olpasiran
What this could lead to
If successful, this could show that olpasiran reduces artery plaque buildup, potentially leading to a new treatment for heart disease in people with high Lp(a).
What could go wrong
This is a Phase 3 trial, but it's still early to know if olpasiran actually prevents heart attacks. The study focuses on plaque changes, not clinical events, and side effects 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 3

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

Participants

About 406 people

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

Started

Mar 2026

Expected to finish

Jun 2028

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

35 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: * Age 35 to ≤ 80 years. * Lp(a) ≥ 200 nmol/L during screening. * Angiographic evidence of coronary artery disease in at least one major epicardial vessel on screening CCTA. * History of myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or coronary revascularization by percutaneous coronary intervention. Exclusion Criteria: * History of coronary artery bypass graft (CABG). * Moderate to severe renal dysfunction. * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN), or total bilirubin (TBL) \> 2 x ULN during screening. * History of hemorrhagic stroke. * History of major bleeding disorder. * Planned cardiac surgery or arterial revascularization. * Severe heart failure. * Current, recent, or planned lipoprotein apheresis. * Previously received ribonucleic acid therapy specifically targeting Lp(a).

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Conditions

The condition(s) this trial relates to.

atherosclerotic cardiovascular disease cardiovascular disorder

As listed by the trial registrant

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

Cardiovascular disease

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    40 sites in 11 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Advara HeartCare Leabrook

    RECRUITING

    Leabrook, South Australia, 5068, Australia

  • Advara HeartCare Wesley

    RECRUITING

    Auchenflower, Queensland, 4066, Australia

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    RECRUITING

    Torino, 10128, Italy

  • Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna

    RECRUITING

    Ferrara, 44124, Italy

  • Bridgeport Hospital

    RECRUITING

    Bridgeport, Connecticut, 06610, United States

  • Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau

    RECRUITING

    Tours, 37044, France

  • Centre Hospitalier Universitaire de Bordeaux Hopital Haut-Leveque

    RECRUITING

    Pessac, 33604, France

  • Centre Hospitalier Universitaire de Nice - Hopital Pasteur

    RECRUITING

    Nice, 06000, France

  • Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

    RECRUITING

    Toulouse, 31059, France

  • Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin

    RECRUITING

    Berlin, 12203, Germany

  • Flourish Bowie

    RECRUITING

    Bowie, Maryland, 20715, United States

  • General Hospital of Ningxia Medical University

    RECRUITING

    Yinchuan, Ningxia, 750004, China

  • Hospital Alvaro Cunqueiro

    RECRUITING

    Vigo, Galicia, 36312, Spain

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, Valencia, 46026, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28023, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, Andalusia, 41009, Spain

  • IRCCS Centro Cardiologico Monzino

    RECRUITING

    Milan, 20138, Italy

  • IRCCS Policlinico San Donato

    RECRUITING

    San Donato Milanese, 20097, Italy

  • Jacksonville Center for Clinical Research

    RECRUITING

    Jacksonville, Florida, 32216, United States

  • Jinan Central Hospital

    RECRUITING

    Jinan, Shandong, 250013, China

  • Klinikum rechts der Isar der TUM

    RECRUITING

    München, 80636, Germany

  • Midwest Heart and Vascular Specialists

    RECRUITING

    Overland Park, Kansas, 66211, United States

  • Montefiore Medical Center - Bronx

    RECRUITING

    Philadelphia, Pennsylvania, 19141, United States

  • North York Diagnostic and Cardiac Centre

    RECRUITING

    Vaughan, Ontario, L6A 4N9, Canada

  • Osaka Keisatsu Hospital

    RECRUITING

    Osaka, Osaka, 543-0042, Japan

  • Peking University First Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • Regionshospitalet Gødstrup

    RECRUITING

    Herning, 7400, Denmark

  • Regionshospitalet Viborg

    RECRUITING

    Viborg, 8800, Denmark

  • Shaanxi Provincial Peoples Hospital

    RECRUITING

    Xi'an, Shaanxi, 710068, China

  • Tergooiziekenhuizen, locatie Hilversum

    RECRUITING

    Hilversum, 1201 DA, Netherlands

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • The Second Affiliated Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210011, China

  • The Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, 410011, China

  • The Third Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, 410013, China

  • Tomakomai City Hospital

    RECRUITING

    Tomakomai-shi, Hokkaido, 053-8567, Japan

  • Universitaetsklinikum Essen

    RECRUITING

    Essen, 45147, Germany

  • Universitaetsklinikum Frankfurt

    RECRUITING

    Frankfurt am Main, 60590, Germany

  • University of The Sunshine Coast Clinical Trials, Sippy Downs

    RECRUITING

    Sippy Downs, Queensland, 4556, Australia

  • University of Yamanashi Hospital

    RECRUITING

    Chuo-shi, Yamanashi, 409-3898, Japan

  • Vital Heart and Vein

    RECRUITING

    Humble, Texas, 77338, United States

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