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
- 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)
Universitaetsklinikum Hamburg-Eppendorf ( Site 0610)
🇩🇪Hamburg, Germany
National Hospital Organization Okayama Medical Center ( Site 2104)
🇯🇵Okayama, Japan
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
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006)
🇦🇷Mar del plata, Buenos Aires, Argentina
Instituto Medico Rio Cuarto ( Site 0010)
🇦🇷Rio Cuarto, Cordoba, 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)
🇨🇦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, China
Yan an Hospital of Kunming City ( Site 2011)
🇨🇳Kunming, Yunnan, China
Clinica Cardio VID ( Site 0307)
🇨🇴Medellín, Antioquia, Colombia
IMAT S.A.S ( Site 0301)
🇨🇴Monteria, Cordoba, Colombia
Fundacion Santa Fe de Bogota ( Site 0302)
🇨🇴Bogota, Cundinamarca, Colombia
Clinica Colsanitas - Sede Reina Sofia ( Site 0303)
🇨🇴Bogota, Distrito Capital De Bogota, Colombia
Centro de Investigaciones Clinicas SAS ( Site 0306)
🇨🇴Cali, Valle Del Cauca, Colombia
Clínica Imbanaco S.A.S ( Site 0304)
🇨🇴Cali, Valle Del Cauca, 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)
🇩🇪Munchen, Bayern, Germany
Medizinische Hochschule Hannover ( Site 0604)
🇩🇪Hannover, Niedersachsen, Germany
Universitätsklinikum Bonn ( Site 0608)
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0609)
🇩🇪Berlin, Germany
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 0704)
🇭🇺Szeged, Csongrad, Hungary
Pécsi Tudományegyetem Klinikai Központ ( Site 0703)
🇭🇺Pécs, Pecs, Hungary
Semmelweis Egyetem ( Site 0701)
🇭🇺Budapest, Pest, 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)
🇮🇹Roma, Lazio, Italy
Ospedale San Martino ( Site 0901)
🇮🇹Genova, Liguria, Italy
ASST Grande Ospedale Metropolitano Niguarda ( Site 0900)
🇮🇹Milan, Lombardia, Italy
Fondazione IRCCS San Gerardo dei Tintori ( Site 0911)
🇮🇹Monza, Lombardia, Italy
A.O.U. Citta della Salute e della Scienza di Torino ( Site 0904)
🇮🇹Torino, Piemonte, Italy
Azienda Ospedaliera Universitaria Integrata ( Site 0908)
🇮🇹Verona, Veneto, Italy
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0902)
🇮🇹Milano, 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, 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
Chonnam National University Hospital (CNUH) ( Site 1304)
🇰🇷Gwangju, Kwangju-Kwangyokshi, Korea, Republic of
Pusan National University Hospital ( Site 1305)
🇰🇷Busan, Pusan-Kwangyokshi, Korea, Republic of
Seoul National University Hospital ( Site 1302)
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 1300)
🇰🇷Seoul, Korea, Republic of
Asan Medical Center ( Site 1303)
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center ( Site 1301)
🇰🇷Seoul, Korea, Republic of
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, Malopolskie, Poland
National University Heart Centre, Singapore ( Site 1200)
🇸🇬Singapore, Central Singapore, Singapore
National Heart Centre Singapore ( Site 1201)
🇸🇬Singapore, Central Singapore, Singapore
Hospital Universitari Son Espases ( Site 1412)
🇪🇸Palma, Baleares, Spain
Hospital Marques de Valdecilla ( Site 1405)
🇪🇸Santander, Cantabria, Spain
Hospital Clinic de Barcelona ( Site 1406)
🇪🇸Barcelona, Cataluna, 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)
🇪🇸Sevilla, Spain
Hospital Universitario de Toledo ( Site 1408)
🇪🇸Toledo, Spain
Kaohsiung Veterans General Hospital ( Site 1503)
🇨🇳Kaohsiung, 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, Krung Thep Maha Nakhon, 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