A double-blind, randomized, placebo-controlled, multicenter study to assess the use of Olpasiran for the prevention of first major cardiovascular events in participants with elevated lipoprotein(a)
Zusammenfassung der Studie
This is a double-blind, randomized, placebo-controlled, multicenter Phase III study to assess the use of Olpasiran for the prevention of a first major cardiovascular event in participants with elevated lipoprotein(a) (Lp[a]) ≥ 200 nmol/l, measured in the central laboratory. Approximately 11,000 participants will be enrolled at around 900 study centers worldwide. This is a combined study. Participants will undergo a two-part pre-screening phase, starting with obtaining informed consent for Lp(a) screening and informed consent for the performance study to assess Lp(a) eligibility criteria before participants consent to the main study. If the Lp(a) level of the participants is > 200 nmol/l, meaning they are eligible, and they wish to proceed with the second part of the pre-screening phase, they will have the opportunity to sign the informed consent for the pre-screening of the main study and enter the pre-screening phase of the main study, where their eligibility will be assessed.
(BASEC)
Untersuchte Intervention
Participants who meet all eligibility criteria will be enrolled and randomized in a 1:1 ratio to receive either subcutaneous (s.c.) Olpasiran or s.c. placebo.
The study is a so-called double-blind study. "Double-blind" means that no one involved in the conduct of the study knows which group the participants have been assigned to: the participants themselves do not know which group they are in. The study doctors also do not know which group individual participants belong to.
Participants are asked to attend all scheduled visits, regardless of their adherence to the study medication. On Day 1 and at each study visit, at least data on vital status and study endpoints should be collected.
(BASEC)
Untersuchte Krankheit(en)
Participants must be at least 50 years old at the time of signing the informed consent for Lp(a) screening, have an Lp(a) level of ≥ 200 nmol/l (confirmed in the central laboratory), and must be at risk for a first major cardiovascular event. Participants must have risk factors for atherosclerotic cardiovascular disease (ASCVD) and/or evidence of atherosclerosis with or without risk factors for ASCVD, as applicable. Participants will be excluded if there is a history of known major cardiovascular events, severe bleeding disorders, or severe renal dysfunction, or if arterial revascularization is planned.
(BASEC)
- Participants have provided written informed consent before the start of any study-specific activities/procedures. - Age ≥ 50 years at the time of signing the informed consent for Lp(a) screening - Lp(a) level ≥ 200 nmol/l at Lp(a) screening, confirmed by the central laboratory - Stable and optimized lipid-lowering therapy for at least 4 weeks - Participants must meet at least one of the following categories (A or B): Presence of one of the risk factors for ASCVD AND/OR Atherosclerosis in the medical history (BASEC)
Ausschlusskriterien
Disease-related - Any prior acute atherothrombotic event that meets the criteria, defined as a prior myocardial infarction, prior stroke, prior transient ischemic attack, or prior acute ischemia in the limbs - Prior arterial revascularization at any time, where there was suspicion of a connection to atherosclerosis Severe bleeding disorder in the past - Planned arterial revascularization (percutaneous or surgical) Diagnostic assessments - Fasting triglycerides > 400 mg/dl (4.52 mmol/l) during screening Other exclusions - Female participants of childbearing potential who are not willing to use the contraceptive method specified in the study protocol during treatment - Participants who are breastfeeding or plan to breastfeed during the study - Participants who plan to become pregnant during the study - Female participants of childbearing potential with a positive pregnancy test, assessed at screening and/or on Day 1 - Participants who, to the best of their knowledge and that of the study doctor, are unlikely to be able to comply with all required study visits and procedures according to the study protocol and/or undergo the required study interventions (BASEC)
Studienstandort
Basel, Bern, Genf, Lausanne, Lugano, Luzern, St Gallen, Zürich
(BASEC)
Sponsor
AMGEN Dr. Nina Reichert One Amgen Center Drive CA 91320 Thousand Oaks 91320 Thousand Oaks United States nreicher@amgen.com +41413690155
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
PD Dr. med. Stefan Bilz
+41 71 494 31 16
endokrinologie@clutterh-och.chHOCH Health Ostschweiz Kantonsspital St.Gallen Klinik für Endokrinologie, Diabetologie, Osteologie und Stoffwechselerkrankungen Rorschacherstrasse 95 9007 St.Gallen
(BASEC)
Wissenschaftliche Auskünfte
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Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Ostschweiz EKOS
(BASEC)
Datum der Bewilligung durch die Ethikkommission
17.07.2025
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
Measurement of Samples with Tina-quant Lp(a) RxDx to Identify Participants with Elevated Lipoprotein(a) for Prevention of First Major Cardiovascular Events and A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants with Elevated Lipoprotein(a) (BASEC)
Wissenschaftlicher Titel
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Öffentlicher Titel
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Studientyp
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Ein-/Ausschlusskriterien
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Primäre und sekundäre Endpunkte
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Einschluss des ersten Teilnehmers
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Ergebnisse der Studie
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