A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024)
NCT ID: NCT06664801
Last Updated: 2025-12-05
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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COMPLETED
PHASE2
164 participants
INTERVENTIONAL
2024-11-14
2025-11-20
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Weight-based sotatercept dosing
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.
Sotatercept
SC administered every 3 weeks.
Background 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
Weight-banded sotatercept dosing
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.
Sotatercept
SC administered every 3 weeks.
Background 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
Interventions
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Sotatercept
SC administered every 3 weeks.
Background 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has symptomatic PAH classified as WHO Functional Class II or III
Exclusion Criteria
* 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
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 1903)
Phoenix, Arizona, United States
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
Clinica Cardio VID ( Site 0307)
Medellín, Antioquia, Colombia
Clinica Colsanitas - Sede Reina Sofia ( Site 0303)
Bogotá, Bogota D.C., Colombia
Fundacion Santa Fe de Bogota ( Site 0302)
Bogota, Cundinamarca, Colombia
IMAT S.A.S ( Site 0301)
Montería, Departamento de Córdoba, Colombia
Centro de Investigaciones Clinicas SAS ( Site 0306)
Cali, Valle del Cauca Department, Colombia
Clínica Imbanaco S.A.S ( Site 0304)
Cali, Valle del Cauca Department, Colombia
Centrum pro plicní hypertenzi VFN II. interni klinika VFN a 1. LF UK ( Site 0400)
Prague, Praha 2, Czechia
CHU Bordeaux Haut-Leveque ( Site 0501)
Pessac, Aquitaine, France
Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0500)
Marseille, Bouches-du-Rhone, France
CHU Dijon Bourgogne ( Site 0502)
Dijon, Cote-d Or, France
CHU de Rouen ( Site 0503)
Rouen, Haute-Normandie, France
CHU GABRIEL MONTPIED ( Site 0504)
Clermont-Ferrand, Puy-de-Dome, France
Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 0600)
Heidelberg, Baden-Wurttemberg, Germany
Klinikum der Universität München Großhadern ( Site 0611)
München, Bavaria, Germany
Medizinische Hochschule Hannover ( Site 0604)
Hanover, Lower Saxony, Germany
Universitätsklinikum Bonn ( Site 0608)
Bonn, North Rhine-Westphalia, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0609)
Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0610)
Hamburg, , Germany
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 0704)
Szeged, Csongrád megye, Hungary
Pécsi Tudományegyetem Klinikai Központ ( Site 0703)
Pécs, Pecs, Hungary
Semmelweis Egyetem ( Site 0701)
Budapest, Pest County, Hungary
Gottsegen Gyorgy Orszagos Kardiologiai Intezet ( Site 0702)
Budapest, , Hungary
Rambam Health Care Campus ( Site 0802)
Haifa, , Israel
Carmel Hospital ( Site 0803)
Haifa, , Israel
Rabin Medical Center ( Site 0805)
Petah Tikva, , Israel
Sheba Medical Center ( Site 0801)
Ramat Gan, , Israel
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0905)
Bologna, Emilia-Romagna, Italy
AOU Policlinico Umberto I ( Site 0910)
Rome, Lazio, Italy
Ospedale San Martino ( Site 0901)
Genoa, Liguria, Italy
ASST Grande Ospedale Metropolitano Niguarda ( Site 0900)
Milan, Lombardy, Italy
Fondazione IRCCS San Gerardo dei Tintori ( Site 0911)
Monza, Lombardy, Italy
A.O.U. Citta della Salute e della Scienza di Torino ( Site 0904)
Turin, Piedmont, Italy
Azienda Ospedaliera Universitaria Integrata ( Site 0908)
Verona, Veneto, Italy
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0902)
Milan, , Italy
Fondazione IRCCS Policlinico San Matteo ( Site 0909)
Pavia, , Italy
Fondazione G. Monasterio ( Site 0907)
Pisa, , Italy
Ospedale Civile SS Annunziata ( Site 0903)
Sassari, , Italy
Nagoya University Hospital ( Site 2102)
Nagoya, Aichi-ken, Japan
National Cerebral and Cardiovascular Center ( Site 2103)
Suita, Osaka, Japan
The University of Tokyo Hospital ( Site 2101)
Bunkyo, Tokyo, Japan
Kyorin University Hospital ( Site 2100)
Mitaka, Tokyo, Japan
Kyushu University Hospital ( Site 2105)
Fukuoka, , Japan
National Hospital Organization Okayama Medical Center ( Site 2104)
Okayama, , Japan
Radboud University Medical Center ( Site 1001)
Nijmegen, Gelderland, Netherlands
Sint Antonius Ziekenhuis ( Site 1000)
Nieuwegein, Utrecht, Netherlands
Krakowski Szpital Specjalistyczny im. św. Jana Pawła II ( Site 1100)
Krakow, Lesser Poland Voivodeship, Poland
National University Heart Centre, Singapore ( Site 1200)
Singapore, Central Singapore, Singapore
National Heart Centre Singapore ( Site 1201)
Singapore, Central Singapore, Singapore
Chonnam National University Hospital (CNUH) ( Site 1304)
Gwangju, Kwangju-Kwangyokshi, South Korea
Pusan National University Hospital ( Site 1305)
Busan, Pusan-Kwangyokshi, South Korea
Seoul National University Hospital ( Site 1302)
Seoul, , South Korea
Severance Hospital Yonsei University Health System ( Site 1300)
Seoul, , South Korea
Asan Medical Center ( Site 1303)
Seoul, , South Korea
Samsung Medical Center ( Site 1301)
Seoul, , South Korea
Hospital Universitari Son Espases ( Site 1412)
Palma, Balearic Islands, Spain
Hospital Marques de Valdecilla ( Site 1405)
Santander, Cantabria, Spain
Hospital Clinic de Barcelona ( Site 1406)
Barcelona, Catalonia, Spain
Hospital Vall D Hebron ( Site 1404)
Barcelona, , Spain
Hospital Ramon y Cajal ( Site 1401)
Madrid, , Spain
Hospital General Universitario 12 de Octubre ( Site 1403)
Madrid, , Spain
Hospital Universitario La Paz ( Site 1410)
Madrid, , Spain
Hospital Virgen del Rocio ( Site 1407)
Seville, , Spain
Hospital Universitario de Toledo ( Site 1408)
Toledo, , Spain
Kaohsiung Veterans General Hospital ( Site 1503)
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital ( Site 1501)
Tainan, , Taiwan
Taipei Veterans General Hospital ( Site 1502)
Taipei, , Taiwan
Faculty of Medicine Siriraj Hospital ( Site 1600)
Bangkok, Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 1601)
Chiang Mai, , Thailand
Royal Papworth Hospital ( Site 1802)
Cambridge, Cambridgeshire, United Kingdom
Royal Free London NHS Foundation Trust ( Site 1803)
London, London, City of, United Kingdom
Royal Brompton Hospital ( Site 1804)
London, London, City of, United Kingdom
Hammersmith Hospital ( Site 1801)
London, London, City of, United Kingdom
Golden Jubilee National Hospital ( Site 1800)
Glasgow, West Dunbartonshire, United Kingdom
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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2024-512278-92-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1304-7985
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-7962-024
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2061240077
Identifier Type: REGISTRY
Identifier Source: secondary_id
7962-024
Identifier Type: -
Identifier Source: org_study_id
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