A clinical study of sotatercept in people with pulmonary arterial hypertension (MK-7962-024)

Prior treatment

• Has history of coronary artery disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass, graft surgery, or cardiac anginal chest pain) (within 6 months prior to study start)
• Has a cerebrovascular accident (within 3 months prior to study start)
• Has recently started (within 12 months prior to study start) or has plans to start weight loss medication or enter a weight loss program during the study period
• Has a previous (within 3 years) or planned (during the study) obesity treatment with surgery or a weight-loss device
• Has a history of atrial septostomy (within 180 days prior to study start)

Other illness

• Has significant (>2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
• Has known malignancy that is progressing or has required active treatment within the past 5 years
• Has diagnosis of Pulmonary Hypertension WHO Groups 2, 3, 4, or 5
• Has a diagnosis of the following PAH Group 1 subtypes: Human Immunodeficiency Virus (HIV)-associated PAH, PAH associated with portal hypertension, Exclusion in PAH Group 1 also includes: schistosomiasis-associated PAH, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis
• Has uncontrolled systemic hypertension
• Has a history of pneumonectomy
• Has a history of known pericardial constriction
• Has a history of restrictive cardiomyopathy

Lab values

• Has personal or family history of long QT syndrome

Other

• Has weight of <35kg
• Has untreated more than mild obstructive sleep apnea

• Has documented diagnostic Right Heart Catheterization, with the diagnosis of World Health Organization (WHO) Pulmonary Atrial Hypertension (PAH) Group 1 in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with connective tissue disease, PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
• Has systemic PAH classified as WHO Functional Class II or III