Pulmonary Arterial Hypertension
Conditions
Brief summary
Researchers are looking for other ways to treat people with PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs. The goal of the study is to learn: * What happens to different doses of sotatercept in a person's body over time when it is given using weight-banded doses compared to weight-based doses. There may be differences in how the medicine works with the new dosing method (weight-banded dosing) being studied in this trial. * About the safety of sotatercept and if people tolerate it
Interventions
BIOLOGICALSotatercept
SC administered every 3 weeks.
BIOLOGICALBackground PAH Therapy
Background PAH therapy may consist of the following drug classes: single, double, or triple combination of therapy with endothelin-receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogs or receptor antagonists
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 symptomatic PAH classified as WHO Functional Class II or III
Exclusion criteria
* Has a weight of \<35 kg * Has a diagnosis of PH WHO Groups 2, 3, 4, or 5 * Has a diagnosis of the following PAH Group 1 subtypes: HIV-associated PAH, PAH associated with portal hypertension, Exclusion in PAH Group 1 should also include 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 * Has history of atrial septostomy (within 180 days prior to study start) * Has personal or family history of long QT syndrome * 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 significant (\>2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease * Has untreated more than mild obstructive sleep apnea * Has known malignancy that is progressing or has required active treatment within the past 5 years * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steady-State Average Serum Concentrations of Sotatercept (Cavg) | Predose and at designated time points post-dose (up to 24 weeks) | Steady-state Cavg of sotatercept will be reported. |
| Number of Participants Who Experience One or More Adverse Events (AEs) | Up to 37 weeks | An AE is a health problem that happens or worsens during a study. Number of participants who experience an AE will be reported. |
| Number of Participants who Discontinue Study Treatment due to an Adverse Event | Up to 21 weeks | An AE is a health problem that happens or worsens during a study. Number of participants who discontinue study treatment will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initial Dose Average Serum Concentrations of Sotatercept (Cavg) | Predose and at designated time points post-dose (up to 3 weeks) | Initial dose Cavg of sotatercept will be reported. |
Countries
Argentina, Australia, Canada, China, Colombia, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Poland, Singapore, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States
Outcome results
None listed