A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024)
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Registration Number
- NCT06664801
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Weight-based sotatercept dosing Sotatercept Participants will receive sotatercept via subcutaneous (SC) injection every 3 weeks at an initial dose of 0.3 mg/kg and then at a maintenance dose of 0.7 mg/kg using a weight-based method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study. Weight-based sotatercept dosing Background PAH Therapy Participants will receive sotatercept via subcutaneous (SC) injection every 3 weeks at an initial dose of 0.3 mg/kg and then at a maintenance dose of 0.7 mg/kg using a weight-based method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study. Weight-banded sotatercept dosing Sotatercept Participants will receive sotatercept via SC injection every 3 weeks at an initial dose of up to 45 mg and then at a maintenance dose of up to 90 mg using a weight-banded method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study. Weight-banded sotatercept dosing Background PAH Therapy Participants will receive sotatercept via SC injection every 3 weeks at an initial dose of up to 45 mg and then at a maintenance dose of up to 90 mg using a weight-banded method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (98)
Pulmonary Associates, PA ( Site 1903)
🇺🇸Phoenix, Arizona, United States
University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular
🇺🇸Aurora, Colorado, United States
Indiana University Health Methodist Hospital ( Site 1905)
🇺🇸Indianapolis, Indiana, United States
University of Kansas Medical Center ( Site 1928)
🇺🇸Kansas City, Kansas, United States
Norton Pulmonary Specialists ( Site 1935)
🇺🇸Louisville, Kentucky, United States
University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916)
🇺🇸Albuquerque, New Mexico, United States
University of Cincinnati Medical Center ( Site 1927)
🇺🇸Cincinnati, Ohio, United States
Ascension Seton Heart Specialty Care and Transplant Center ( Site 1918)
🇺🇸Austin, Texas, United States
Froedtert Hospital & the Medical College of Wisconsin ( Site 1934)
🇺🇸Milwaukee, Wisconsin, United States
Centro Medico Capital ( Site 0002)
🇦🇷La Plata, Buenos Aires, Argentina
Scroll for more (88 remaining)Pulmonary Associates, PA ( Site 1903)🇺🇸Phoenix, Arizona, United States