Clinical trial • Phase III • Cardiology
OLPASIRAN for Atherosclerotic cardiovascular disease | Cardiovascular disease
Phase III trial of OLPASIRAN for Atherosclerotic cardiovascular disease | Cardiovascular disease.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Atherosclerotic cardiovascular disease | Cardiovascular disease
- Trial Stage
- Phase III
- Drug Modality
- Oligonucleotide
Key dates
- Initial CTIS Submission Date
- 28-08-2025
- First CTIS Authorization Date
- 22-12-2025
Trial design
Randomised, amg 890 (olpasiran) - subcutaneous vs. matching placebo (placebo for amg 890) randomized 1:1; dose and schedule not specified in provided data.-controlled Phase III trial across 34 sites in Denmark, France, Germany and others.
- Randomised
- Yes
- Comparator
- AMG 890 (Olpasiran) - subcutaneous vs. matching placebo (placebo for AMG 890) randomized 1:1; dose and schedule not specified in provided data.
- Target Sample Size
- 220
- Trial Duration For Participant
- 504
Eligibility
Recruits 220 No vulnerable populations selected (isVulnerablePopulationSelected: false)..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false).
Inclusion criteria
- {"criterion_text":"- Participants must be 35 to ≤ 80 years of age\n- screening Lp(a) ≥ 200 nmol/L and a history of ASCVD. Atherosclerotic cardiovascular disease is defined as a history of either myocardial infarction (MI) (presumed type 1 event due to plaque rupture/erosion) and/or coronary revascularization by percutaneous coronary intervention (PCI)\n- The screening (baseline) imaging scan must meet the CCTA imaging criteria as determined by the central imaging laboratory"}
Exclusion criteria
- {"criterion_text":"- CCTA not meeting CCTA imaging criteria after two attempts during the baseline CCTA visit as assessed by the central imaging laboratory.\n- History of major bleeding disorder\n- Planned cardiac surgery, arterial revascularization, or planned major non-cardiac surgery during the study period."}
Endpoints
Primary endpoints
- {"endpoint_text":"- change in non-calcified plaque volume from baseline to week 72","definition_or_measurement_approach":"Measured by Coronary Computed Tomography Angiography (CCTA); change from baseline to week 72."}
Secondary endpoints
- {"endpoint_text":"- change in the following volume types from baseline to week 72: -low attenuation plaque volume -total plaque volume -calcified plaque volume","definition_or_measurement_approach":"Measured by Coronary Computed Tomography Angiography (CCTA); changes from baseline to week 72 for low attenuation plaque volume, total plaque volume, and calcified plaque volume."}
Recruitment
- Registry Or Advocacy Recruitment
- Yes
- Planned Sample Size
- 220
- Recruitment Window Months
- 26
- Consent Approach
- Informed consent obtained from adult participants (no minors enrolled; ages 35 to ≤80). Subject information sheets and informed consent forms (L1_SIS and ICF) are provided; country- and language-specific ICF versions exist (documents available for Germany, France, Spain, Italy, Netherlands, etc.). Separate ICFs for pre-screening, pregnancy follow-up, genetic research and withdrawal are provided. Consent is provided by participants themselves; no assent process for minors is applicable.
Methods
- K1/K2 Recruitment arrangements documents (titles present in registry) — country-specific recruitment arrangements documents provided (e.g., K1_Recruitment Arrangments, K1_Recruitment procedure_For Publication).
- Physician Referral Letter — country-specific physician referral letters present (e.g., Physician Referral Letter versions for Germany, France, Italy, Netherlands, Spain, Denmark).
- Patient Brochure / CCTA Patient brochure — patient-facing brochures for multiple countries (e.g., Patient Brochure_For Publication, CCTA Patient brochure).
- Lp(a) Educational Brochure — educational materials about Lp(a) for patients (country-specific versions).
- Subject information and informed consent forms (L1_SIS and ICF) including pre-screening, main ICF, genetic research, pregnancy follow-up templates (multiple language/country versions).
Geography
- Total Number Of Sites
- 34
- Total Number Of Participants
- 178
Denmark
- Earliest CTIS Part Ii Submission Date
- 05-12-2025
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 17
- Number Of Sites
- 4
- Number Of Participants
- 30
Sites
- Site Name
- Region Midtjylland
- Department Name
- Cardiology
- Principal Investigator Name
- Nikolaj Thure Krarup
- Principal Investigator Email
- nikolaj.krarup@rm.dk
- Contact Person Name
- Nikolaj Thure Krarup
- Contact Person Email
- nikolaj.krarup@rm.dk
- Site Name
- Region Midtjylland
- Department Name
- Cardiology
- Principal Investigator Name
- Morten Bottcher
- Principal Investigator Email
- morboett@rm.dk
- Contact Person Name
- Morten Bottcher
- Contact Person Email
- morboett@rm.dk
- Site Name
- Region Hovedstaden
- Department Name
- Kardiologisk Afdelning Y
- Principal Investigator Name
- Merete Heitmann
- Principal Investigator Email
- Merete.Heitmann@regionh.dk
- Contact Person Name
- Merete Heitmann
- Contact Person Email
- Merete.Heitmann@regionh.dk
- Site Name
- Aarhus Universitet
- Department Name
- Cardiology
- Principal Investigator Name
- Henrik Kjaerulf Jensen
- Principal Investigator Email
- henrijen@rnm.dk
- Contact Person Name
- Henrik Kjaerulf Jensen
- Contact Person Email
- henrijen@rnm.dk
France
- Earliest CTIS Part Ii Submission Date
- 25-11-2025
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 27
- Number Of Sites
- 5
- Number Of Participants
- 25
Sites
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Cardiology
- Principal Investigator Name
- Meyer ELBAZ
- Principal Investigator Email
- elbaz.m@chu-toulouse.fr
- Contact Person Name
- Meyer ELBAZ
- Contact Person Email
- elbaz.m@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Cardiology
- Principal Investigator Name
- Emile FERRARI
- Principal Investigator Email
- ferrari.e@chu-nice.fr
- Contact Person Name
- Emile FERRARI
- Contact Person Email
- ferrari.e@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Cardiology outpatient consultations
- Principal Investigator Name
- Thierry COUFFINHAL
- Principal Investigator Email
- thierry.couffinhal@inserm.fr
- Contact Person Name
- Thierry COUFFINHAL
- Contact Person Email
- thierry.couffinhal@inserm.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Cardiology
- Principal Investigator Name
- Fabrice IVANES
- Principal Investigator Email
- f.ivanes@chu-tours.fr
- Contact Person Name
- Fabrice IVANES
- Contact Person Email
- f.ivanes@chu-tours.fr
- Site Name
- Les Hopitaux De Chartres
- Department Name
- Cardiology
- Principal Investigator Name
- Christophe THUAIRE
- Principal Investigator Email
- cthuaire@ch-chartres.fr
- Contact Person Name
- Christophe THUAIRE
- Contact Person Email
- cthuaire@ch-chartres.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 24-11-2025
- Latest Decision Or Authorization Date
- 08-01-2026
- Processing Time Days
- 45
- Number Of Sites
- 5
- Number Of Participants
- 21
Sites
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Universitäres Herz- und Gefäßzentrum Hamburg, Klinik für Kardiologie
- Principal Investigator Name
- Natalie Arnold
- Principal Investigator Email
- n.arnold@uke.de
- Contact Person Name
- Natalie Arnold
- Contact Person Email
- n.arnold@uke.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Deutsches Herzzentrum der Charité (DHZC) Klinik für Kardiologie, Angiologie und Intensivmedizin
- Principal Investigator Name
- Ulf Landmesser
- Principal Investigator Email
- ulf.landmesser@dhzc-charite.de
- Contact Person Name
- Ulf Landmesser
- Contact Person Email
- ulf.landmesser@dhzc-charite.de
- Site Name
- TUM Klinikum Deutsches Herzzentrum
- Department Name
- Klinik für Herz- Kreislaufkrankheiten
- Principal Investigator Name
- Wolfgang Koenig
- Principal Investigator Email
- cmctu@dhm.mhn.de
- Contact Person Name
- Wolfgang Koenig
- Contact Person Email
- cmctu@dhm.mhn.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Studienzentrum Kardiologie, Universitäres Herz- und Gefäßzentrum Med. Klinik3 Kardiologie Angiologie
- Principal Investigator Name
- Badder Kattih
- Principal Investigator Email
- studien-herzzentrum@unimedizin-ffm.de
- Contact Person Name
- Badder Kattih
- Contact Person Email
- studien-herzzentrum@unimedizin-ffm.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Westdeutsches Herz- und Gefaesszentrum - Klinik für Kardiologie und Angiologie
- Principal Investigator Name
- Amir Abbas Mahabadi
- Principal Investigator Email
- kardio-ctu@uk-essen.de
- Contact Person Name
- Amir Abbas Mahabadi
- Contact Person Email
- kardio-ctu@uk-essen.de
Italy
- Earliest CTIS Part Ii Submission Date
- 25-11-2025
- Latest Decision Or Authorization Date
- 23-12-2025
- Processing Time Days
- 28
- Number Of Sites
- 6
- Number Of Participants
- 30
Sites
- Site Name
- Ospedale Galeazzi S.p.A.
- Department Name
- Unità Operativa di Cardiologia Clinica ed Imaging Cardiaco e di Cardiologia dello Sport
- Principal Investigator Name
- Daniele Andreini
- Principal Investigator Email
- daniele.andreini@unimi.it
- Contact Person Name
- Daniele Andreini
- Contact Person Email
- daniele.andreini@unimi.it
- Site Name
- Azienda Ospedaliera Ordine Mauriziano Di Torino
- Department Name
- Struttura Complessa Cardiologia
- Principal Investigator Name
- Giuseppe Musumeci
- Principal Investigator Email
- gmusumeci@mauriziano.it
- Contact Person Name
- Giuseppe Musumeci
- Contact Person Email
- gmusumeci@mauriziano.it
- Site Name
- Policlinico San Donato S.p.A.
- Department Name
- Unita di Cardiologia Clinica Interventistica e di Terapia Intensiva Coronarica
- Principal Investigator Name
- Francesco Bedogni
- Principal Investigator Email
- Francesco.Bedogni@grupposandonato.it
- Contact Person Name
- Francesco Bedogni
- Contact Person Email
- Francesco.Bedogni@grupposandonato.it
- Site Name
- Azienda Ospedaliera Dei Colli
- Department Name
- Unita Operativa Complessa Cardiologia e unita di terapia intensiva coronarica
- Principal Investigator Name
- Paolo Golino
- Principal Investigator Email
- paolo.golino@ospedalideicolli.it
- Contact Person Name
- Paolo Golino
- Contact Person Email
- paolo.golino@ospedalideicolli.it
- Site Name
- Centro Cardiologico Monzino S.p.A.
- Department Name
- Dipartimento Cardiologia perioperatoria e Imaging cardiovascolare
- Principal Investigator Name
- Gianluca Pontone
- Principal Investigator Email
- gianluca.pontone@cardiologicomonzino.it
- Contact Person Name
- Gianluca Pontone
- Contact Person Email
- gianluca.pontone@cardiologicomonzino.it
- Site Name
- University Hospital Of Ferrara
- Department Name
- Cardiologia
- Principal Investigator Name
- Paolo Cimaglia
- Principal Investigator Email
- paolo.cimaglia@ospfe.it
- Contact Person Name
- Paolo Cimaglia
- Contact Person Email
- paolo.cimaglia@ospfe.it
Netherlands
- Earliest CTIS Part Ii Submission Date
- 09-12-2025
- Latest Decision Or Authorization Date
- 05-01-2026
- Processing Time Days
- 27
- Number Of Sites
- 8
- Number Of Participants
- 51
Sites
- Site Name
- Stichting OLVG
- Department Name
- Cardiology
- Principal Investigator Name
- Rick Halbmeijer
- Principal Investigator Email
- r.halbmeijer@olvg.nl
- Contact Person Name
- Rick Halbmeijer
- Contact Person Email
- r.halbmeijer@olvg.nl
- Site Name
- Tergooiziekenhuizen
- Department Name
- Cardiology
- Principal Investigator Name
- Jacobus Plomp
- Principal Investigator Email
- jplomp@tergooi.nl
- Contact Person Name
- Jacobus Plomp
- Contact Person Email
- jplomp@tergooi.nl
- Site Name
- Amphia Hospital
- Department Name
- Cardiology
- Principal Investigator Name
- Jeroen Schaap
- Principal Investigator Email
- jschaap@amphia.nl
- Contact Person Name
- Jeroen Schaap
- Contact Person Email
- jschaap@amphia.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Vascular medicine
- Principal Investigator Name
- Bimmer Claessen
- Principal Investigator Email
- b.e.claessen@amsterdamumc.nl
- Contact Person Name
- Bimmer Claessen
- Contact Person Email
- b.e.claessen@amsterdamumc.nl
- Site Name
- Spaarne Gasthuis Stichting
- Department Name
- Cardiology
- Principal Investigator Name
- Mitran Keijzers
- Principal Investigator Email
- mkeijzer@spaarnegasthuis.nl
- Contact Person Name
- Mitran Keijzers
- Contact Person Email
- mkeijzer@spaarnegasthuis.nl
- Site Name
- Stichting Viecuri Medisch Centrum voor Noord-Limburg
- Department Name
- Cardiology
- Principal Investigator Name
- Wouter Remkes
- Principal Investigator Email
- wremkes@viecuri.nl
- Contact Person Name
- Wouter Remkes
- Contact Person Email
- wremkes@viecuri.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Cardiology
- Principal Investigator Name
- Maarten Leening
- Principal Investigator Email
- m.leening@erasmusmc.nl
- Contact Person Name
- Maarten Leening
- Contact Person Email
- m.leening@erasmusmc.nl
- Site Name
- Haga Hospital
- Department Name
- Cardiology
- Principal Investigator Name
- Wilco Tanis
- Principal Investigator Email
- w.tanis@hagaziekenhuis.nl
- Contact Person Name
- Wilco Tanis
- Contact Person Email
- w.tanis@hagaziekenhuis.nl
Spain
- Earliest CTIS Part Ii Submission Date
- 11-12-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 53
- Number Of Sites
- 6
- Number Of Participants
- 21
Sites
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Servicio de Cardiologia
- Principal Investigator Name
- Antoni Martinez Rubio
- Principal Investigator Email
- amartinezr@tauli.cat
- Contact Person Name
- Antoni Martinez Rubio
- Contact Person Email
- amartinezr@tauli.cat
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Servicio de Cardiologia
- Principal Investigator Name
- Diana Domingo Valero
- Principal Investigator Email
- ines_roche@iislafe.es
- Contact Person Name
- Diana Domingo Valero
- Contact Person Email
- ines_roche@iislafe.es
- Site Name
- Hospital Universitario De Leon
- Department Name
- Servicio de Cardiologia
- Principal Investigator Name
- Ignacio Iglesias Garriz
- Principal Investigator Email
- jiiglesias@saludcastillayleon.es
- Contact Person Name
- Ignacio Iglesias Garriz
- Contact Person Email
- jiiglesias@saludcastillayleon.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Servicio de Cardiologia
- Principal Investigator Name
- Jose Luis Zamorano Gomez
- Principal Investigator Email
- zamorano@secardiologia.es
- Contact Person Name
- Jose Luis Zamorano Gomez
- Contact Person Email
- zamorano@secardiologia.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Servicio de Cardiologia
- Principal Investigator Name
- Rafael Jesús Hidalgo Urbano
- Principal Investigator Email
- rjhidalur@yahoo.es
- Contact Person Name
- Rafael Jesús Hidalgo Urbano
- Contact Person Email
- rjhidalur@yahoo.es
- Site Name
- Hospital Alvaro Cunqueiro
- Department Name
- Servicio de Cardiologia
- Principal Investigator Name
- Victor Alfonso Jimenez Diaz
- Principal Investigator Email
- victor.alfonso.jimenez.diaz@sergas.es
- Contact Person Name
- Victor Alfonso Jimenez Diaz
- Contact Person Email
- victor.alfonso.jimenez.diaz@sergas.es
Sponsor
Primary sponsor
- Full Name
- Amgen Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Iqvia Rds Inc.
- Responsibilities
- code 1
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- code 4
- Name
- Suvoda LLC
- Responsibilities
- code 3
Third parties
- {"country":"United States","full_name":"The Brigham And Women’s Hospital Inc.","duties_or_roles":"Scientific consultancy and Event adjudication","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Limited","duties_or_roles":"\"Investigator Recruitment Development of Recruitment Tools\"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"Quipment","duties_or_roles":"Provision of study equipment (eg. Freezers) to investigational sites","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"code 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Olpasiran
- Active Substance
- OLPASIRAN
- Modality
- Oligonucleotide
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- SUBCUTANEOUS
- Authorisation Status
- prodAuthStatus: 1; MIA number: 108520 F
- Maximum Dose
- 00
- Investigational Product Name
- Placebo for AMG 890
- Modality
- Other
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