Study to assess the impact of Lipoprotein(a) reduction with Pelacarsen (TQJ230) on the progression of calcific aortic stenosis [Lp(a)FRONTIERS CAVS]

Zusammenfassung der Studie

In this study, we aim to find out whether the study drug Pelacarsen (also known as TQJ230) can help adults diagnosed with mild or moderate calcific aortic stenosis (CAVS) and elevated Lipoprotein(a) [Lp(a)]. Approximately 502 people worldwide with CAVS who are at least 50 years old are invited to participate in this study. CAVS is a condition where the opening of the aortic valve narrows, restricting blood flow from the heart to the rest of the body, which can lead to health problems. Lipoprotein(a) [Lp(a)] is a lipid particle found in the blood and resembles LDL cholesterol (the so-called "bad cholesterol"). It is discussed that it may increase the risk of developing CAVS. The study drug Pelacarsen is not yet approved in Switzerland for the treatment of people with elevated Lp(a). To date, there is no medication that slows the progression of CAVS.

(BASEC)

Untersuchte Intervention

In our study, there are 2 treatment groups:

- Pelacarsen: You have a 1:1 (50 %) chance of receiving the study drug.

- Placebo: You have a 1:1 (50 %) chance of receiving the placebo, which contains no active substance.

The study drug and the placebo will be administered to you every month by subcutaneous injection (with a needle under the skin) for 3 years.

The placebo is an injection of an inactive substance and has no effect.

(BASEC)

Untersuchte Krankheit(en)

Calcific aortic stenosis (CAVS)

(BASEC)

Sponsor

Novartis Pharma Schweiz AG

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Zürich

(BASEC)

Datum der Bewilligung durch die Ethikkommission

19.04.2024

(BASEC)

Ergebnisse der Studie