Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)
NCT ID: NCT06814145
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
130 participants
INTERVENTIONAL
2025-04-16
2029-03-30
Brief Summary
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Researchers want to know if the study treatment, sotatercept, can treat people with Cpc-PH caused by HFpEF. This is an extension study, which means people who took part in a certain study on sotatercept for Cpc-PH (called a parent study) may be able to join this study. In this extension study, people will take sotatercept and researchers will follow their health for a longer time.
The main goal of this extension study is to learn about the long-term safety of sotatercept and if people tolerate it over a longer period of time.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sotatercept 0.3 mg/kg
Participants receive sotatercept 0.3 mg/kg subcutaneous (SC) injection every 3 weeks (Q3W) for up to approximately 168 weeks or until discontinuation.
Sotatercept
subcutaneous injection
Sotatercept 0.7 mg/kg
Participants receive sotatercept 0.7 mg/kg SC injection Q3W for up to approximately 168 weeks or until discontinuation.
Sotatercept
subcutaneous injection
Interventions
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Sotatercept
subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Has had a study intervention interruption
* Is pregnant or breastfeeding
* Has chronic liver disease with severe hepatic impairment and/or cirrhosis (eg, hepatic encephalopathy)
* Anticipation of more than 1 valve replacement or repair (mechanical or biomechanical) and/or have undergone more than 1 valve replacement or repair
* Has severe tricuspid regurgitation due to primary valvular disease (eg, from endocarditis, carcinoid, or mechanical destruction)
* Anticipated or undergone heart transplant or ventricular assist device implantation
* Has had prior exposure to luspatercept
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Pulmonary Associates, PA ( Site 1008)
Phoenix, Arizona, United States
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
Santa Barbara, California, United States
Stanford University Medical Center ( Site 1024)
Stanford, California, United States
South Denver Cardiology Associates ( Site 1091)
Littleton, Colorado, United States
AdventHealth Orlando ( Site 1058)
Orlando, Florida, United States
The Emory Clinic ( Site 1030)
Atlanta, Georgia, United States
Norton Pulmonary Specialists ( Site 1066)
Louisville, Kentucky, United States
University Of Nebraska Medical Center ( Site 1053)
Omaha, Nebraska, United States
Weill Cornell Medical Center ( Site 1046)
New York, New York, United States
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
Cincinnati, Ohio, United States
Allegheny General Hospital ( Site 1088)
Pittsburgh, Pennsylvania, United States
Lankenau Medical Center ( Site 1089)
Wynnewood, Pennsylvania, United States
Medical University of South Carolina ( Site 1003)
Charleston, South Carolina, United States
Statcare Pulmonary Consultants ( Site 1031)
Knoxville, Tennessee, United States
Intermountain Medical Center ( Site 1079)
Murray, Utah, United States
Inova Heart and Vascular Institute ( Site 1078)
Falls Church, Virginia, United States
Pulmonary Associates of Richmond - West Broad Street ( Site 1069)
Richmond, Virginia, United States
Université Libre de Bruxelles - Hôpital Erasme ( Site 0100)
Brussels, Bruxelles-Capitale, Region de, Belgium
Hamilton Health Sciences Hamilton General Hospital ( Site 0004)
Hamilton, Ontario, Canada
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 0206)
Nice, Alpes-Maritimes, France
Hopital Arnaud de Villeneuve ( Site 0200)
Montpellier, Herault, France
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 0205)
Saint-Herblain, Loire-Atlantique, France
Centre Hopitalier Universitaire d'Angers ( Site 0204)
Angers, Maine-et-Loire, France
CHU de Rouen ( Site 0203)
Rouen, Seine-Maritime, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0202)
Le Kremlin-Bicêtre, Val-de-Marne, France
Thoraxklinik-Heidelberg gGmbH ( Site 0309)
Heidelberg, Baden-Wurttemberg, Germany
UKGM Gießen/Marburg ( Site 0312)
Giessen, Hesse, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 0315)
Mainz, Rhineland-Palatinate, Germany
Rambam Health Care Campus ( Site 0403)
Haifa, , Israel
Edith Wolfson Medical Center ( Site 0404)
Holon, , Israel
Hadassah Medical Center ( Site 0402)
Jerusalem, , Israel
Meir Medical Center ( Site 0401)
Kfar Saba, , Israel
ZIV Medical Center ( Site 0400)
Safed, , Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0502)
Bergamo, Lombardy, Italy
Fondazione IRCCS Policlinico San Matteo ( Site 0501)
Pavia, , Italy
AOU Policlinico Umberto I ( Site 0500)
Roma, , Italy
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 0601)
Lublin, Lublin Voivodeship, Poland
Hospital Costa del Sol ( Site 0704)
Marbella, Malaga, Spain
Hospital Clinic I Provincial de Barcelona ( Site 0701)
Barcelona, , Spain
Hospital Universitario 12 de Octubre ( Site 0702)
Madrid, , Spain
Hospital Universitario Virgen Macarena ( Site 0705)
Seville, , Spain
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 0703)
Toledo, , Spain
Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0800)
Gothenburg, Västra Götaland County, Sweden
Hammersmith Hospital-Department of Cardiology ( Site 0900)
London, London, City of, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-7962-023
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1309-2142
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-515773-99-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
7962-023
Identifier Type: -
Identifier Source: org_study_id