Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
398
Countries
6
Sites
34
Cardiovascular Disease
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
- Sponsor
- Amgen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 11 Mar 2026 → ongoing
- Decision date (initial)
- 2025-12-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Amgen Inc.
External identifiers
- EU CT number
- 2025-521117-88-00
- WHO UTN
- U1111-1320-6856
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To evaluate the effect of olpasiran compared to placebo, on non-calcified plaque (NCP) volume as measured by Coronary Computed Tomography Angiography (CCTA)
Secondary objectives 1
- To evaluate the effect of olpasiran, compared to placebo, on changes in different plaque types and morphologies as measured by CCTA: - low attenuation plaque volume change - total plaque volume change - calcified plaque volume change
Conditions and MedDRA coding
Cardiovascular Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10051615 | Atherosclerotic cardiovascular disease | 10047065 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | 1 Period with 2 arms (1 arm with AMG 890 (olpasiran) and 1 arm with placebo) Subjects will be randomized in a 1:1 ratio, with 1 arm being treated with AMG 890 (olpasiran) and 1 arm with placebo
|
Randomised Controlled | Double | [{"id":174075,"code":2,"name":"Investigator"},{"id":174074,"code":3,"name":"Monitor"},{"id":174073,"code":4,"name":"Analyst"},{"id":174076,"code":5,"name":"Carer"},{"id":174077,"code":1,"name":"Subject"}] | AMG 890 (olpasiran) - SC: Subjects will be randomized 1:1 to receive olpasiran AMG 890 (olpasiran) matching placebo - SC: Subjects will be randomized 1:1 to receive olpasiran matching placebo |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participants must be 35 to ≤ 80 years of age
- 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)
- The screening (baseline) imaging scan must meet the CCTA imaging criteria as determined by the central imaging laboratory
Exclusion criteria 3
- CCTA not meeting CCTA imaging criteria after two attempts during the baseline CCTA visit as assessed by the central imaging laboratory.
- History of major bleeding disorder
- Planned cardiac surgery, arterial revascularization, or planned major non-cardiac surgery during the study period.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- change in non-calcified plaque volume from baseline to week 72
Secondary endpoints 1
- change in the following volume types from baseline to week 72: -low attenuation plaque volume -total plaque volume -calcified plaque volume
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD12878302 · Product
- Active substance
- Olpasiran
- Substance synonyms
- RNA, (Cm-sp-Am-Gm-Cm-Cm-Cm-Cm-Um-(2’-deoxy-2’-fluoro)U-(2’-deoxy-2’-fluoro)A-(2’-deoxy-2’-fluoro)U-Um-Gm-Um-Um-Am-Um-Am-Cm-Gm-(3'->3')-sp-dA), 5’-[O-[(23S,28S)-37-[[(2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]-23,28-bis[[[2-[2-[[2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]ethoxy]ethyl]amino]carbonyl]-21,26,31-trioxo-3,6,9,12,15,18,35-heptaoxa-22,27,32-triazaheptacont-1-yl] hydrogen phosphorothioate], complex with RNA (Um-sp-(2’-deoxy-2’-fluoro)C-sp-Gm-(2’-deoxy-2’-fluoro)U-Am-(2’-deoxy-2’-fluoro)U-Am-Am-Cm-Am-Am-(2’-deoxy-2’-fluoro)U-Am-(2’-deoxy-2’-fluoro)A-Gm-(2’-deoxy-2’-fluoro)G-Gm-(2’-deoxy-2’-fluoro)G-Cm-sp-(2’-deoxy-2’-fluoro)U-sp-Gm), AMG 890
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 9999 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- AMGEN INC
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amgen Inc.
- Sponsor organisation
- Amgen Inc.
- Address
- 1 Amgen Center Drive
- City
- Thousand Oaks
- Postcode
- 91320-1730
- Country
- United States
Scientific contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| The Brigham And Women’s Hospital Inc. ORG-100030562
|
Boston, United States | Other |
| Publicis Healthcare Communications Group Limited ORG-100044665
|
London, United Kingdom | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Quipment ORG-100043496
|
Nancy, France | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
Locations
6 EU/EEA countries · 34 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 30 | 4 |
| France | Ongoing, recruiting | 25 | 5 |
| Germany | Ongoing, recruiting | 21 | 5 |
| Italy | Ongoing, recruiting | 30 | 6 |
| Netherlands | Authorised, recruiting | 51 | 8 |
| Spain | Authorised, recruiting | 21 | 6 |
| Rest of world
United States, Australia, Canada, Japan, China
|
— | 220 | — |
Investigational sites
Region Midtjylland
Cardiology, Hospitalsparken 15, 7400, Herning
Region Hovedstaden
Kardiologisk Afdelning Y, Nordre Fasanvej 57, 1st Floor Entrance 2, Frederiksberg
Aarhus Universitet
Cardiology, Palle Juul-Jensens Boulevard 82, 8200, Aarhus N
Region Midtjylland
Cardiology, Heibergs Alle 5a, 8800, Viborg
Les Hopitaux De Chartres
Cardiology, 4 Rue Claude Bernard, 28630, Le Coudray
Centre Hospitalier Universitaire De Bordeaux
Cardiology outpatient consultations, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Nice
Cardiology, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Universitaire De Toulouse
Cardiology, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Regional Universitaire De Tours
Cardiology, Avenue De La Republique, 37170, Chambray Les Tours
Goethe University Frankfurt
Studienzentrum Kardiologie, Universitäres Herz- und Gefäßzentrum Med. Klinik3 Kardiologie Angiologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Charite Universitaetsmedizin Berlin KöR
Deutsches Herzzentrum der Charité (DHZC) Klinik für Kardiologie, Angiologie und Intensivmedizin, Hindenburgdamm 30, Lichterfelde, Berlin
Universitaetsklinikum Essen AöR
Westdeutsches Herz- und Gefaesszentrum - Klinik für Kardiologie und Angiologie, Hufelandstrasse 55, Holsterhausen, Essen
University Medical Center Hamburg-Eppendorf
Universitäres Herz- und Gefäßzentrum Hamburg, Klinik für Kardiologie, Martinistrasse 52, Eppendorf, Hamburg
TUM Klinikum Deutsches Herzzentrum
Klinik für Herz- Kreislaufkrankheiten, Lazarettstrasse 36, Neuhausen-Nymphenburg, Munich
University Hospital Of Ferrara
Cardiologia, Via Aldo Moro 8, 44124, Ferrara
Centro Cardiologico Monzino S.p.A.
Dipartimento Cardiologia perioperatoria e Imaging cardiovascolare, Via Carlo Parea 4, 20138, Milan
Ospedale Galeazzi S.p.A.
Unità Operativa di Cardiologia Clinica ed Imaging Cardiaco e di Cardiologia dello Sport, Via Cristina Belgioioso 173, 20157, Milan
Policlinico San Donato S.p.A.
Unita di Cardiologia Clinica Interventistica e di Terapia Intensiva Coronarica, Piazza Edmondo Malan 2, 20097, San Donato Milanese
Azienda Ospedaliera Dei Colli
Unita Operativa Complessa Cardiologia e unita di terapia intensiva coronarica, Via Leonardo Bianchi, 80131, Naples
Azienda Ospedaliera Ordine Mauriziano Di Torino
Struttura Complessa Cardiologia, Via Ferdinando Magellano 1, 10128, Turin
Amphia Hospital
Cardiology, Molengracht 21, 4818 CK, Breda
Spaarne Gasthuis Stichting
Cardiology, Boerhaavelaan 22, 2035 RC, Haarlem
Amsterdam UMC Stichting
Vascular medicine, Meibergdreef 9, 1105 AZ, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Cardiology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Haga Hospital
Cardiology, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Tergooiziekenhuizen
Cardiology, Van Riebeeckweg 212, 1213 XZ, Hilversum
Stichting OLVG
Cardiology, Oosterpark 9, 1091 AC, Amsterdam
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Cardiology, Tegelseweg 210, 5912 BL, Venlo
Hospital Alvaro Cunqueiro
Servicio de Cardiologia, Estrada Clara Campoamor No 341, 36312, Vigo
Hospital Universitario De Leon
Servicio de Cardiologia, Calle Altos De Nava S/n, 24071, Leon
Hospital Universitario Ramon Y Cajal
Servicio de Cardiologia, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Y Politecnico La Fe
Servicio de Cardiologia, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Virgen De La Macarena
Servicio de Cardiologia, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Parc Tauli Hospital Universitari
Servicio de Cardiologia, Parc Del Tauli 1, 08208, Sabadell
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2026-03-26 | 2026-03-27 | |||
| France | 2026-03-19 | 2026-03-31 | |||
| Germany | 2026-03-16 | 2026-03-19 | |||
| Italy | 2026-03-11 | 2026-03-16 | |||
| Netherlands | 2026-03-31 | ||||
| Spain | 2026-03-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 64 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_ENG_2025-521117-88_20230191_CSS_For publication | 1 |
| Protocol (for publication) | D1_Protocol_ENG_2025-521117-88_20230191_For Publication | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements and ICF procedure FP | 08Dec2025 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_For Publication | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_For Publication | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangments_Germany_20230191_fP | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment procedure_For Publication | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Physician Referral Letter_For Publication | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Physician Referral Letter_For Publication | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Educational Brochure_For Publication | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Lpa Educational Brochure FP | 12MAY2025 |
| Recruitment arrangements (for publication) | K2_Recruitment material Patient Brochure_For Publication | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Physician Referral Letter FP | 01AUG2025 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_ Physician Referral Letter_Germany_20230191_fP | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CCTA Patient brochure_FP | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Lipoprotein a Educational brochure_FP | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_LPa Educational Brochure_For Publication | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Lpa Educational Brochure_For Publication | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_For Publication | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_For Publication | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral letter_ For Publication | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Referral Letter_FP | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS-ICF_FR_20230191_Germany_fP | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS-ICF_Genetic_20230191_Germany_fP | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS-ICF_Lp a Test_20230191_Germany_fP | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS-ICF_Main_20230191_Germany_fP | 2.2 |
| Subject information and informed consent form (for publication) | L1_Informed consent procedure_Germany_20230191_fP | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum FP | 12AUG2025 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Follow-up Child Father-Second Holder of Parental Authority_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_Spain_For Publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Lpa FP | 09Dec2025 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Lpa_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LPa_Spain_For Publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main FP | 09Dec2025 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Screening_Spain_For Publication | 2.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Screening_Spain_Not For Publication | 2.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Follow-up Child Mother_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Follow-up Mother_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Man_Spain_For Publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Woman_Spain_For Publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Withdrawal Spain_For Publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Withdrawal_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic Research_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Lpa_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_FP | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Father ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Mother ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening ICF_FP | 1.2 |
| Subject information and informed consent form (for publication) | L2 Other subject information material Informed consent procedure_For Publication | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Informed consent procedure_For Publication | 1 |
| Subject information and informed consent form (for publication) | L2_Informed consent procedure_For Publication | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material GP Letter_For Publication | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information Participants rights in a trial FP | 02FEB2024 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_ENG_2025-521117-88_20230191_PLPS_For Publication | 1 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_ES_2025-521117-88_20230191_PLPS_For Publication | 1 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_FR_2025-521117-88_20230191_PLPS_For Publication | 1 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_IT_2025-521117-88_20230191_PLPS_For Publication | 1 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_IT_Full_2025-521117-88_20230191_For Publication | 1 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_NL_2025-521117-88_20230191_PLPS_For Publication | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-28 | Denmark | Acceptable 2025-12-22
|
2025-12-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-19 | Acceptable | 2026-02-02 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-06 | Denmark | Acceptable 2026-04-23
|
2026-04-24 |