ZENITH
Sotatercept in High-Risk Pulmonary Arterial Hypertension
Patient / Population Intervention / Exposure Comparison Outcome
In 172 patients with high-risk pulmonary arterial hypertension, sotatercept reduced death, lung transplantation or heart-failure hospitalisation compared with placebo.
N
172
Design
Double-blind RCT, stopped early
Endpoint
Death, lung transplant or PAH hospitalisation
Relevance
2
ResultHR 0.24 (76 % reduction in the primary composite).
Humbert M, et al. N Engl J Med. 2025;392(20):1987-2000. 10.1056/NEJMoa2415160
Discussion & critique
Confirmed a hard-outcome benefit in the sickest PAH patients (functional class III–IV). Small and stopped early, which can inflate the effect estimate.