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

NCT07293260 · tracked via the Priya Life Science USA tracker

Sponsor

Amgen

Phase

Phase 3

Started

2026-03-23

Last updated

2026-04-16

Condition(s) studied

Cardiovascular Disease

Investigational drug(s) / intervention(s)

OlpasiranPlacebo

Olpasiran: Olpasiran will be administered SC.

Placebo: Placebo will be administered SC.

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

Sex

ALL

Min age

35 Years

Max age

80 Years

Healthy volunteers

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).

Primary outcome measure(s)

Change in NCP Volume from Baseline to Week 72 — Baseline to Week 72

Trial sites (40)

Facility	City	Region	Status
Bridgeport Hospital	Bridgeport	Connecticut	Recruiting
Jacksonville Center for Clinical Research	Jacksonville	Florida	Recruiting
Midwest Heart and Vascular Specialists	Overland Park	Kansas	Recruiting
Flourish Bowie	Bowie	Maryland	Recruiting
Montefiore Medical Center - Bronx	Philadelphia	Pennsylvania	Recruiting
Vital Heart and Vein	Humble	Texas	Recruiting
Advara HeartCare Wesley	Auchenflower	Queensland	Recruiting
University of The Sunshine Coast Clinical Trials, Sippy Downs	Sippy Downs	Queensland	Recruiting
Advara HeartCare Leabrook	Leabrook	South Australia	Recruiting
North York Diagnostic and Cardiac Centre	Vaughan	Ontario	Recruiting
Peking University First Hospital	Beijing	Beijing Municipality	Recruiting
The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	Recruiting
The Second Xiangya Hospital of Central South University	Changsha	Hunan	Recruiting
The Third Xiangya Hospital of Central South University	Changsha	Hunan	Recruiting
The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	Recruiting
General Hospital of Ningxia Medical University	Yinchuan	Ningxia	Recruiting
Shaanxi Provincial Peoples Hospital	Xi'an	Shaanxi	Recruiting
Jinan Central Hospital	Jinan	Shandong	Recruiting
Regionshospitalet Gødstrup	Herning	Denmark	Recruiting
Regionshospitalet Viborg	Viborg	Denmark	Recruiting
Centre Hospitalier Universitaire de Nice - Hopital Pasteur	Nice	France	Recruiting
Centre Hospitalier Universitaire de Bordeaux Hopital Haut-Leveque	Pessac	France	Recruiting
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil	Toulouse	France	Recruiting
Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau	Tours	France	Recruiting
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin	Berlin	Germany	Recruiting
Universitaetsklinikum Essen	Essen	Germany	Recruiting
Universitaetsklinikum Frankfurt	Frankfurt am Main	Germany	Recruiting
Klinikum rechts der Isar der TUM	München	Germany	Recruiting
Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna	Ferrara	Italy	Recruiting
IRCCS Centro Cardiologico Monzino	Milan	Italy	Recruiting
IRCCS Policlinico San Donato	San Donato Milanese	Italy	Recruiting
Azienda Ospedaliera Ordine Mauriziano di Torino	Torino	Italy	Recruiting
Tomakomai City Hospital	Tomakomai-shi	Hokkaido	Recruiting
Osaka Keisatsu Hospital	Osaka	Osaka	Recruiting
University of Yamanashi Hospital	Chuo-shi	Yamanashi	Recruiting
Tergooiziekenhuizen, locatie Hilversum	Hilversum	Netherlands	Recruiting
Hospital Universitario Virgen Macarena	Seville	Andalusia	Recruiting
Hospital Alvaro Cunqueiro	Vigo	Galicia	Recruiting
Hospital Universitari i Politecnic La Fe	Valencia	Valencia	Recruiting
Hospital Universitario Ramon y Cajal	Madrid	Spain	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07293260 on ClinicalTrials.gov ↗ ← All trials in the USA