A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024)
Completed · Phase 2
Conditions studied: Pulmonary Arterial Hypertension
In brief
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
Key facts
- Study ID
- NCT06664801
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 164
- Starts
- 2024-11-14
- Expected to finish
- 2025-11-20
- Last updated by the study team
- 2025-12-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 1930) — 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
- Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006) — Mar del Plata, Buenos Aires, Argentina
- Instituto Medico Rio Cuarto ( Site 0010) — Río Cuarto, Córdoba Province, Argentina
- Hospital Britanico de Buenos Aires ( Site 0004) — CABA, Argentina
- Instituto de Cardiologia Juana F. Cabral ( Site 0008) — Corrientes, Argentina
- Hospital Provincial Jose Maria Cullen ( Site 0005) — Santa Fe, Argentina
- Royal Prince Alfred Hospital ( Site 0103) — Camperdown, New South Wales, Australia
- Westmead Hospital ( Site 0100) — Westmead, New South Wales, Australia
- Wesley Research Institute ( Site 0101) — Auchenflower, Queensland, Australia
- The Alfred Hospital ( Site 0102) — Melbourne, Victoria, Australia
- Peter Lougheed Centre ( Site 0203) — Calgary, Alberta, Canada
- IUCPQ ( Site 0208) — Québec, Quebec, Canada
- Guangdong Provincial People s Hospital ( Site 2000) — Guangzhou, Guangdong, China
- The Second Xiangya Hospital of Central South University ( Site 2002) — Changsha, Hunan, China
- Shanghai Pulmonary Hospital ( Site 2004) — Shanghai, Shanghai Municipality, China
- Yan an Hospital of Kunming City ( Site 2011) — Kunming, Yunnan, China
- Pulmonary Associates, PA ( Site 1903) — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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