Clinical Study of Sotatercept in Adults with Pulmonary Arterial Hypertension (PAH)

Résumé de l'étude

Sotatercept is a new medication being developed to help people with two lung diseases: pulmonary arterial hypertension (PAH) and pulmonary hypertension (PH) associated with left heart disease. Sotatercept consists of two proteins found in our body. One is called Activin Receptor Type IIA, and the other is Human Immunoglobulin G1. This study is being conducted to test the safety of Sotatercept and to investigate how well Sotatercept works in the long term for individuals with PAH. Only individuals currently participating in the MK7962-004 study (also known as SOTERIA) can participate in this study. The estimated combined duration of this study and the MK7962-004 study is up to 7 years. Approximately 815 patients are expected to participate in this study worldwide. About 2 patients are expected to participate in Switzerland.

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Intervention étudiée

In this study, all participants will receive Sotatercept, which will be administered alongside other standard treatments for PAH. Sotatercept will be injected subcutaneously every 3 weeks. This is called a subcutaneous (s.c.) injection. The dose of Sotatercept may change during the study; however, the patient and study staff will be informed of the dose being administered.

The treatment phase lasts about two and a half years, and participants will visit the study clinic every 3 months. Additionally, it may be necessary for patients to come to the clinic every 3 weeks during this time; however, these visits may be conducted by phone, depending on whether the study medication is administered at the study clinic or at home.

During study visits, various examinations and procedures may be conducted, such as tests that show how your heart is functioning, including electrocardiogram (ECG) and echocardiogram (ECHO), blood tests, 6-minute walk test (6MWT: this test measures how far you can walk in 6 minutes), or right heart catheterization (RHC: a procedure to check heart function and measure pressure in the heart and lungs).

After stopping the medication, a follow-up phase begins with visits 3 and 8 weeks after the last dose of Sotatercept. Subsequently, the study team will contact you about 12 weeks (approximately 3 months) and about 16 weeks (approximately 4 months) after your last dose of the study medication.

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Maladie en cours d'investigation

This study examines Sotatercept (MK-7962) in adults with pulmonary arterial hypertension (PAH). PAH is a form of high blood pressure that affects the arteries leading from the heart to the lungs. It can cause strain on the right side of the heart. Sotatercept is experimental. It has been approved for the treatment of PAH under certain conditions in some countries, such as Switzerland. Sotatercept is also known as MK-7962 and WINREVAIR™ in countries where it is approved. Two Phase 3 studies (STELLAR and ZENITH) showed a significant benefit for participants treated with Sotatercept compared to the control group.

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Sponsor

MSD Merck Sharp & Dohme AG

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Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Commission cantonale de Zurich

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Date d'approbation du comité d'éthique

09.01.2026

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Résultats de l'essai