SIRIUS - Initial Combination Therapy With an Endothelin Receptor Antagonist, a Phosphodiesterase-5 Inhibitor and Sotatercept in Patients With Newly Diagnosed Pulmonary Arterial Hypertension

The study aims to see how 24 weeks of triple therapy-an endothelin receptor antagonist (ERA), a phosphodiesterase-5 inhibitor (PDE5i), and sotatercept-affects pulmonary vascular resistance (PVR) in patients with newly diagnosed pulmonary arterial hypertension (PAH). SIRIUS is a 24-week, single-arm, open-label study with up to 42 days of screening and a 28-day safety follow-up. It will enroll 25 patients and will be conducted only in countries where all treatments are available and covered. After 24 weeks, PAH treatment is decided by the doctor.

NCT Number	NCT07266519
Lead Sponsor	Philipps University Marburg Collaborators: MSD Sharp & Dohme GmbH, Germany
Conditions	Pulmonary Arterial Hypertension (PAH)
Enrollment	25 participants
Start Date	2026-07-01
Primary Completion	2028-10 (estimated)
Study Completion	2028-10 (estimated)
Updated on ClinicalTrials.gov	2025-12-05