Clinical Trials

Inclusion Criteria:

- Target population: greater than or equal to (>=) 18 (or the legal age of consent in
the jurisdiction in which the study is taking place) years of age

- Target population: Symptomatic Pulmonary Arterial Hypertension (PAH) in World Health
Organization Functional Class (WHO FC) II, III, or IV

- Target population: PAH subtype falling in one of the below classifications:
Idiopathic; Heritable; Drug- or toxin-induced; Related to: Connective tissue disease,
HIV infection, Portal hypertension, and Congenital heart disease with
small/coincidental cardiac defect with systemic-to-pulmonary shunt (for example atrial
septal defect, ventricular septal defect, patent ductus arteriosus, atrioventricular
septal defect) which does not account for the elevated pulmonary vascular resistance
(PVR) or persistent PAH documented by an Right heart catheterization (RHC) >= 1 year
after simple systemic-to pulmonary shunt repair

- PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to
screening: Mean pulmonary artery pressure (mPAP) greater than (>) 20 millimeters of
mercury (mm Hg), and; Pulmonary artery wedge pressure (PAWP) or left ventricular end
diastolic pressure (LVEDP) less than or equal to (<=) 15 mm Hg, and PVR >= 3 Wood
Units (that is, >= 240 dyn*sec/cm^5)

- Able to perform the 6-minute walking test (6MWT) with a minimum distance of 50 meters
(m) and maximum distance of 440m at screening. Participants able to walk more than
440m at screening are eligible if they are in WHO FC III or IV and n-terminal
prohormone of brain natriuretic peptide or n-terminal pro B-type natriuretic peptide
(NT-proBNP) level is >=300 nanograms per liter (ng/L) at screening, based on central
laboratory results

Exclusion Criteria:

- Known presence of three or more of the following risk factors for heart failure with
preserved ejection fraction at screening, based on records that confirm documented
medical history: Body mass index (BMI) > 30 kilograms per meter square (kg/m^2),
Diabetes mellitus of any type, Essential hypertension (even if well controlled);
Coronary artery disease, that is, any of the following: history of stable angina, or
known more than 50 percent (%) stenosis in a coronary artery, or history of myocardial
infarction, or history of or planned coronary artery bypass grafting and/or coronary
artery stenting

- Presence of moderate or severe obstructive lung disease (forced expiratory volume in 1
second [FEV1] / forced vital capacity [FVC] < 70%; and FEV1 < 60% of predicted after
bronchodilator administration) ) in participants with a known or suspected history of
significant lung disease as documented by a spirometry test performed within 1 year
prior to screening

- Known moderate to severe hepatic impairment, defined as Child-Pugh Class B or C, based
on records that confirm documented medical history

- Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >
1.5*upper limit of normal (ULN) at screening

- Hemoglobin < 100 gram per liter (g/L) (< 10 gram per deciliter [g/dL]) at screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 7/11/23. Questions regarding updates should be directed to the study team contact.