A Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) in India (MK-7962-037)

A Phase 4, Prospective, Open-label, Single-Arm Study to Evaluate the Safety of Sotatercept in Adults With Pulmonary Arterial Hypertension (PAH) in India

Researchers are looking for other ways to treat people in India with pulmonary arterial hypertension (PAH), also known as Group 1 pulmonary hypertension (PH). In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs. This causes high blood pressure in the lungs and can overwork the heart. PAH can make it hard to breathe and be active.

Researchers want to learn if sotatercept, the study medicine, can be given with standard treatment to help treat PAH. The standard treatment (the usual treatment) for PAH includes one or multiple medicines. However, these may not fully work or treat the symptoms of PAH in some people.

The goal of this study is to learn about the safety and tolerability of sotatercept when it is given with standard treatment to people in India.

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

• Has documented historical diagnostic right heart catheterization (RHC), with the diagnosis of pulmonary arterial hypertension (PAH), also known as Group 1 pulmonary hypertension (PH), in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with connective tissue disease, and PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
• Has been on stable doses of PAH background therapies and diuretics (if applicable)
• Has symptomatic PAH classified as World Health Organization (WHO) Functional Classification (FC) II or III

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

• Has a diagnosis of Groups 2, 3, 4, or 5 PH
• Has a diagnosis of the following PAH (Group 1 PH) subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH, PAH diagnosed with pulmonary veno occlusive disease (PVOD) or pulmonary capillary hemangiomatosis (PCH)
• Has uncontrolled systemic hypertension
• Has a history of full or partial pneumonectomy
• Has untreated more than mild obstructive sleep apnea
• Has known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C
• Has a history of restrictive, constrictive, or congestive cardiomyopathy
• Has significant mitral regurgitation or aortic regurgitation valvular disease, mitral stenosis, and more than mild aortic valve stenosis
• Has known malignancy that is progressing or has required active treatment within the past 5 years