Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography Trial

Last updated: April 15, 2026
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

3

Condition

Cardiovascular Disease

Heart Disease

Diabetes Prevention

Treatment

Placebo

Olpasiran

Clinical Study ID

NCT07293260
20230191
  • Ages 35-80
  • All Genders

Study Summary

The primary objective of this trial is to evaluate the effect of olpasiran, compared to placebo, on non-calcified plaque (NCP) volume as measured by Coronary Computed Tomography Angiography (CCTA).

Eligibility Criteria

Inclusion

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 epicardialvessel on screening CCTA.

  • History of myocardial infarction (presumed type 1 event due to plaquerupture/erosion) and/or coronary revascularization by percutaneous coronaryintervention.

Exclusion

Exclusion Criteria:

  • History of coronary artery bypass graft (CABG).

  • Moderate to severe renal dysfunction.

  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limitof 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).

Study Design

Total Participants: 406
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
March 23, 2026
Estimated Completion Date:
June 15, 2028

Connect with a study center

  • Advara HeartCare Wesley

    Auchenflower, Queensland 4066
    Australia

    Active - Recruiting

  • University of The Sunshine Coast Clinical Trials, Sippy Downs

    Sippy Downs, Queensland 4556
    Australia

    Active - Recruiting

  • Advara HeartCare Leabrook

    Leabrook, South Australia 5068
    Australia

    Active - Recruiting

  • North York Diagnostic and Cardiac Centre

    Vaughan, Ontario L6A 4N9
    Canada

    Active - Recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality 100034
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Active - Recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan 410013
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu 210011
    China

    Active - Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia 750004
    China

    Active - Recruiting

  • Shaanxi Provincial Peoples Hospital

    Xi'an, Shaanxi 710068
    China

    Active - Recruiting

  • Jinan Central Hospital

    Jinan, Shandong 250013
    China

    Active - Recruiting

  • Regionshospitalet Gødstrup

    Herning, 7400
    Denmark

    Active - Recruiting

  • Regionshospitalet Viborg

    Viborg, 8800
    Denmark

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nice - Hopital Pasteur

    Nice, 06000
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Bordeaux Hopital Haut-Leveque

    Pessac, 33604
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

    Toulouse, 31059
    France

    Active - Recruiting

  • Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau

    Tours, 37044
    France

    Active - Recruiting

  • Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin

    Berlin, 12203
    Germany

    Active - Recruiting

  • Universitaetsklinikum Essen

    Essen, 45147
    Germany

    Active - Recruiting

  • Universitaetsklinikum Frankfurt

    Frankfurt am Main, 60590
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar der TUM

    München, 80636
    Germany

    Active - Recruiting

  • Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna

    Ferrara, 44124
    Italy

    Active - Recruiting

  • IRCCS Centro Cardiologico Monzino

    Milan, 20138
    Italy

    Active - Recruiting

  • IRCCS Policlinico San Donato

    San Donato Milanese, 20097
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, 10128
    Italy

    Active - Recruiting

  • Tomakomai City Hospital

    Tomakomai-shi, Hokkaido 053-8567
    Japan

    Active - Recruiting

  • Osaka Keisatsu Hospital

    Osaka, Osaka 543-0042
    Japan

    Active - Recruiting

  • University of Yamanashi Hospital

    Chuo-shi, Yamanashi 409-3898
    Japan

    Active - Recruiting

  • Tergooiziekenhuizen, locatie Hilversum

    Hilversum, 1201 DA
    Netherlands

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, Andalusia 41009
    Spain

    Active - Recruiting

  • Hospital Alvaro Cunqueiro

    Vigo, Galicia 36312
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, Valencia 46026
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28023
    Spain

    Active - Recruiting

  • Bridgeport Hospital

    Bridgeport, Connecticut 06610
    United States

    Active - Recruiting

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Midwest Heart and Vascular Specialists

    Overland Park, Kansas 66211
    United States

    Active - Recruiting

  • Flourish Bowie

    Bowie, Maryland 20715
    United States

    Active - Recruiting

  • Montefiore Medical Center - Bronx

    Philadelphia, Pennsylvania 19141
    United States

    Active - Recruiting

  • Vital Heart and Vein

    Humble, Texas 77338
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.