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

NCT07293260 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 20230191
• Study Type: interventional
• Target: 406
• Locations: 11 countries
• Sites: 40

Brief 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).

Conditions

Cardiovascular Disease

Keywords

Stable Atherosclerotic Cardiovascular Disease; Elevated Lipoprotein(a); Coronary Artery Plaque Burden; Olpasiran

Outcome Measures

Primary Outcomes (1)

• Change in NCP Volume from Baseline to Week 72

  Baseline to Week 72

Secondary Outcomes (4)

• Change in Low Attenuation Plaque Volume from Baseline to Week 72

  Baseline to Week 72

• Change in Total Plaque Volume from Baseline to Week 72

  Baseline to Week 72

• Change in Calcified Plaque Volume from Baseline to Week 72

  Baseline to Week 72

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  Up to Week 74

Study Arms (2)

Olpasiran

EXPERIMENTAL

Participants will receive olpasiran subcutaneously (SC) once every 12 weeks (Q12W).

Drug: Olpasiran

Placebo

PLACEBO COMPARATOR

Participants will receive placebo SC Q12W.

Drug: Placebo

Interventions

Olpasiran DRUG

Olpasiran will be administered SC.

Also known as: AMG 890

Olpasiran

Placebo DRUG

Placebo will be administered SC.

Placebo

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Amgen: lead

Study Sites (40)

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

RECRUITING

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

RECRUITING

Midwest Heart and Vascular Specialists

Overland Park, Kansas, 66211, United States

RECRUITING

Flourish Bowie

Bowie, Maryland, 20715, United States

RECRUITING

Montefiore Medical Center - Bronx

Philadelphia, Pennsylvania, 19141, United States

RECRUITING

Vital Heart and Vein

Humble, Texas, 77338, United States

RECRUITING

Advara HeartCare Wesley

Auchenflower, Queensland, 4066, Australia

RECRUITING

University of The Sunshine Coast Clinical Trials, Sippy Downs

Sippy Downs, Queensland, 4556, Australia

RECRUITING

Advara HeartCare Leabrook

Leabrook, South Australia, 5068, Australia

RECRUITING

North York Diagnostic and Cardiac Centre

Vaughan, Ontario, L6A 4N9, Canada

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

RECRUITING

Shaanxi Provincial Peoples Hospital

Xi'an, Shaanxi, 710068, China

RECRUITING

Jinan Central Hospital

Jinan, Shandong, 250013, China

RECRUITING

Regionshospitalet Gødstrup

Herning, 7400, Denmark

RECRUITING

Regionshospitalet Viborg

Viborg, 8800, Denmark

RECRUITING

Centre Hospitalier Universitaire de Nice - Hopital Pasteur

Nice, 06000, France

RECRUITING

Centre Hospitalier Universitaire de Bordeaux Hopital Haut-Leveque

Pessac, 33604, France

RECRUITING

Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

Toulouse, 31059, France

RECRUITING

Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau

Tours, 37044, France

RECRUITING

Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin

Berlin, 12203, Germany

RECRUITING

Universitaetsklinikum Essen

Essen, 45147, Germany

RECRUITING

Universitaetsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

RECRUITING

Klinikum rechts der Isar der TUM

München, 80636, Germany

RECRUITING

Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna

Ferrara, 44124, Italy

RECRUITING

IRCCS Centro Cardiologico Monzino

Milan, 20138, Italy

RECRUITING

IRCCS Policlinico San Donato

San Donato Milanese, 20097, Italy

RECRUITING

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, 10128, Italy

RECRUITING

Tomakomai City Hospital

Tomakomai-shi, Hokkaido, 053-8567, Japan

RECRUITING

Osaka Keisatsu Hospital

Osaka, Osaka, 543-0042, Japan

RECRUITING

University of Yamanashi Hospital

Chuo-shi, Yamanashi, 409-3898, Japan

RECRUITING

Tergooiziekenhuizen, locatie Hilversum

Hilversum, 1201 DA, Netherlands

RECRUITING

Hospital Universitario Virgen Macarena

Seville, Andalusia, 41009, Spain

RECRUITING

Hospital Alvaro Cunqueiro

Vigo, Galicia, 36312, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28023, Spain

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

olpasiran

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 19, 2025
• Study Start: March 23, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

AU (3); CN (8); DE (4); DK (2); JP (3); NL (1); FR (4); CA (1); US (6); IT (4); ES (4)