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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Cardiovascular Disease

In brief

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).

Key facts

Study ID

NCT07293260

Run by

Amgen

People needed

406

Starts

2026-03-23

Expected to finish

2028-06-15

Last updated by the study team

2026-04-16

Who can join

Age: 35 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (enrolling)
• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (enrolling)
• The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
• General Hospital of Ningxia Medical University — Yinchuan, Ningxia, China (enrolling)
• Shaanxi Provincial Peoples Hospital — Xi'an, Shaanxi, China (enrolling)
• Jinan Central Hospital — Jinan, Shandong, China (enrolling)
• Regionshospitalet Gødstrup — Herning, Denmark (enrolling)
• Regionshospitalet Viborg — Viborg, Denmark (enrolling)
• Centre Hospitalier Universitaire de Nice - Hopital Pasteur — Nice, France (enrolling)
• Centre Hospitalier Universitaire de Bordeaux Hopital Haut-Leveque — Pessac, France (enrolling)
• Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil — Toulouse, France (enrolling)
• Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau — Tours, France (enrolling)
• Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin — Berlin, Germany (enrolling)
• Universitaetsklinikum Essen — Essen, Germany (enrolling)
• Universitaetsklinikum Frankfurt — Frankfurt am Main, Germany (enrolling)
• Klinikum rechts der Isar der TUM — München, Germany (enrolling)
• Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna — Ferrara, Italy (enrolling)
• IRCCS Centro Cardiologico Monzino — Milan, Italy (enrolling)
• IRCCS Policlinico San Donato — San Donato Milanese, Italy (enrolling)
• Azienda Ospedaliera Ordine Mauriziano di Torino — Torino, Italy (enrolling)
• Tomakomai City Hospital — Tomakomai-shi, Hokkaido, Japan (enrolling)
• Osaka Keisatsu Hospital — Osaka, Osaka, Japan (enrolling)
• University of Yamanashi Hospital — Chuo-shi, Yamanashi, Japan (enrolling)
• Tergooiziekenhuizen, locatie Hilversum — Hilversum, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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