A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024)

Last updated: July 11, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Not Recruiting

Phase

2

Condition

Pulmonary Arterial Hypertension

Circulation Disorders

Williams Syndrome

Treatment

Sotatercept

Background PAH Therapy

Clinical Study ID

NCT06664801
7962-024
2024-512278-92-00
U1111-1304-7985
MK-7962-024
2024-512278-92
jRCT2061240077
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has documented diagnostic Right Heart Catheterization, with the diagnosis of WorldHealth Organization (WHO) Pulmonary Atrial Hypertension (PAH) Group 1 in any of thefollowing subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAHassociated with connective tissue disease, PAH associated with simple, congenitalsystemic-to-pulmonary shunts at least 1 year following repair

  • Has symptomatic PAH classified as WHO Functional Class II or III

Exclusion

Exclusion Criteria:

  • 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, PAHassociated with portal hypertension, Exclusion in PAH Group 1 should also includeschistosomiasis-associated PAH, pulmonary veno occlusive disease and pulmonarycapillary 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 coronaryintervention, 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 regurgitationvalvular disease

  • Has untreated more than mild obstructive sleep apnea

  • Has known malignancy that is progressing or has required active treatment within thepast 5 years

  • Has recently started (within 12 months prior to study start) or has plans to startweight 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 withsurgery or a weight-loss device

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Sotatercept
Phase: 2
Study Start date:
November 14, 2024
Estimated Completion Date:
November 20, 2025

Connect with a study center

  • Centro Medico Capital ( Site 0002)

    La Plata, Buenos Aires B1904AAW
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006)

    Mar del plata, Buenos Aires B7600FZO
    Argentina

    Site Not Available

  • Instituto Medico Rio Cuarto ( Site 0010)

    Rio Cuarto, Cordoba X5800AEV
    Argentina

    Site Not Available

  • Hospital Britanico de Buenos Aires ( Site 0004)

    Caba, C1280AEB
    Argentina

    Site Not Available

  • Instituto de Cardiologia Juana F. Cabral ( Site 0008)

    Corrientes, W3400AMZ
    Argentina

    Site Not Available

  • Hospital Provincial Jose Maria Cullen ( Site 0005)

    Santa Fe, 3000
    Argentina

    Site Not Available

  • Royal Prince Alfred Hospital ( Site 0103)

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Westmead Hospital ( Site 0100)

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Wesley Research Institute ( Site 0101)

    Auchenflower, Queensland 4066
    Australia

    Site Not Available

  • The Alfred Hospital ( Site 0102)

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Peter Lougheed Centre ( Site 0203)

    Calgary, Alberta T1Y 6J4
    Canada

    Site Not Available

  • IUCPQ ( Site 0208)

    Quebec, G1V 4G5
    Canada

    Site Not Available

  • Guangdong Provincial People s Hospital ( Site 2000)

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University ( Site 2002)

    Changsha, Hunan 410011
    China

    Site Not Available

  • Shanghai Pulmonary Hospital ( Site 2004)

    Shanghai, Shanghai 200433
    China

    Site Not Available

  • Yan an Hospital of Kunming City ( Site 2011)

    Kunming, Yunnan 650051
    China

    Site Not Available

  • Clinica Cardio VID ( Site 0307)

    Medellín, Antioquia 050034
    Colombia

    Site Not Available

  • IMAT S.A.S ( Site 0301)

    Monteria, Cordoba 230002
    Colombia

    Site Not Available

  • Oncomedica S.A. ( Site 0301)

    Monteria, Cordoba 230002
    Colombia

    Active - Recruiting

  • Fundacion Santa Fe de Bogota ( Site 0302)

    Bogota, Cundinamarca 110111
    Colombia

    Site Not Available

  • Clinica Colsanitas - Sede Reina Sofia ( Site 0303)

    Bogota, Distrito Capital De Bogota 110111
    Colombia

    Site Not Available

  • Centro de Investigaciones Clinicas SAS ( Site 0306)

    Cali, Valle Del Cauca 760036
    Colombia

    Site Not Available

  • Clínica Imbanaco S.A.S ( Site 0304)

    Cali, Valle Del Cauca 760042
    Colombia

    Site Not Available

  • Centrum pro plicní hypertenzi VFN II. interni klinika VFN a 1. LF UK ( Site 0400)

    Prague, Praha 2 128 08
    Czechia

    Site Not Available

  • CHU Bordeaux Haut-Leveque ( Site 0501)

    Pessac, Aquitaine 33604
    France

    Site Not Available

  • Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0500)

    Marseille, Bouches-du-Rhone 13015
    France

    Site Not Available

  • CHU Dijon Bourgogne ( Site 0502)

    Dijon, Cote-d Or 2100
    France

    Site Not Available

  • CHU de Rouen ( Site 0503)

    Rouen, Haute-Normandie 76000
    France

    Site Not Available

  • CHU GABRIEL MONTPIED ( Site 0504)

    Clermont-Ferrand, Puy-de-Dome 63003
    France

    Site Not Available

  • Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 0600)

    Heidelberg, Baden-Wurttemberg 69126
    Germany

    Site Not Available

  • Klinikum der Universität München Großhadern ( Site 0611)

    Munchen, Bayern 81377
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover ( Site 0604)

    Hannover, Niedersachsen 30625
    Germany

    Site Not Available

  • Universitätsklinikum Bonn ( Site 0608)

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Site Not Available

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0609)

    Berlin, 10117
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg-Eppendorf ( Site 0610)

    Hamburg, 20246
    Germany

    Site Not Available

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 0704)

    Szeged, Csongrad 6725
    Hungary

    Site Not Available

  • Pécsi Tudományegyetem Klinikai Központ ( Site 0703)

    Pécs, Pecs 7624
    Hungary

    Site Not Available

  • Semmelweis Egyetem ( Site 0701)

    Budapest, Pest 1083
    Hungary

    Site Not Available

  • Gottsegen Gyorgy Orszagos Kardiologiai Intezet ( Site 0702)

    Budapest, 1096
    Hungary

    Site Not Available

  • Carmel Hospital ( Site 0803)

    Haifa, 3436212
    Israel

    Site Not Available

  • Rambam Health Care Campus ( Site 0802)

    Haifa, 3109601
    Israel

    Site Not Available

  • Rabin Medical Center ( Site 0805)

    Petah-Tikva, 4941492
    Israel

    Site Not Available

  • Sheba Medical Center ( Site 0801)

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0905)

    Bologna, Emilia-Romagna 40138
    Italy

    Site Not Available

  • AOU Policlinico Umberto I ( Site 0910)

    Roma, Lazio 00161
    Italy

    Site Not Available

  • Ospedale San Martino ( Site 0901)

    Genova, Liguria 16132
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0900)

    Milan, Lombardia 20162
    Italy

    Site Not Available

  • Fondazione IRCCS San Gerardo dei Tintori ( Site 0911)

    Monza, Lombardia 20900
    Italy

    Site Not Available

  • A.O.U. Citta della Salute e della Scienza di Torino ( Site 0904)

    Torino, Piemonte 10126
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Integrata ( Site 0908)

    Verona, Veneto 37126
    Italy

    Site Not Available

  • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0902)

    Milano, 20122
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo ( Site 0909)

    Pavia, 27100
    Italy

    Site Not Available

  • Fondazione G. Monasterio ( Site 0907)

    Pisa, 56124
    Italy

    Site Not Available

  • Ospedale Civile SS Annunziata ( Site 0903)

    Sassari, 07100
    Italy

    Site Not Available

  • Nagoya University Hospital ( Site 2102)

    Nagoya, Aichi 466-8560
    Japan

    Site Not Available

  • National Cerebral and Cardiovascular Center ( Site 2103)

    Suita, Osaka 564-8565
    Japan

    Site Not Available

  • The University of Tokyo Hospital ( Site 2101)

    Bunkyo, Tokyo 113-8655
    Japan

    Site Not Available

  • Kyorin University Hospital ( Site 2100)

    Mitaka, Tokyo 181-8611
    Japan

    Site Not Available

  • Kyushu University Hospital ( Site 2105)

    Fukuoka, 812-8582
    Japan

    Site Not Available

  • National Hospital Organization Okayama Medical Center ( Site 2104)

    Okayama, 701-1192
    Japan

    Site Not Available

  • Chonnam National University Hospital (CNUH) ( Site 1304)

    Gwangju, Kwangju-Kwangyokshi 61469
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital ( Site 1305)

    Busan, Pusan-Kwangyokshi 49241
    Korea, Republic of

    Site Not Available

  • Asan Medical Center ( Site 1303)

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center ( Site 1301)

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital ( Site 1302)

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System ( Site 1300)

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Radboud University Medical Center ( Site 1001)

    Nijmegen, Gelderland 6525 GA
    Netherlands

    Site Not Available

  • Sint Antonius Ziekenhuis ( Site 1000)

    Nieuwegein, Utrecht 3435CM
    Netherlands

    Site Not Available

  • Krakowski Szpital Specjalistyczny im. św. Jana Pawła II ( Site 1100)

    Krakow, Malopolskie 31-202
    Poland

    Site Not Available

  • National Heart Centre Singapore ( Site 1201)

    Singapore, Central Singapore 169609
    Singapore

    Site Not Available

  • National University Heart Centre, Singapore ( Site 1200)

    Singapore, Central Singapore 119074
    Singapore

    Site Not Available

  • Hospital Universitari Son Espases ( Site 1412)

    Palma, Baleares 07120
    Spain

    Site Not Available

  • Hospital Marques de Valdecilla ( Site 1405)

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona ( Site 1406)

    Barcelona, Cataluna 08036
    Spain

    Site Not Available

  • Hospital Vall D Hebron ( Site 1404)

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital General Universitario 12 de Octubre ( Site 1403)

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Ramon y Cajal ( Site 1401)

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario La Paz ( Site 1410)

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Virgen del Rocio ( Site 1407)

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario de Toledo ( Site 1408)

    Toledo, 45007
    Spain

    Site Not Available

  • Kaohsiung Veterans General Hospital ( Site 1503)

    Kaohsiung, 813414
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital ( Site 1501)

    Tainan, 70403
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital ( Site 1502)

    Taipei, 11217
    Taiwan

    Site Not Available

  • Faculty of Medicine Siriraj Hospital ( Site 1600)

    Bangkok, Krung Thep Maha Nakhon 10700
    Thailand

    Site Not Available

  • Maharaj Nakorn Chiang Mai Hospital ( Site 1601)

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Papworth Hospital NHS Foundation Trust ( Site 1802)

    Cambridge, Cambridgeshire CB23 3RE
    United Kingdom

    Active - Recruiting

  • Royal Papworth Hospital ( Site 1802)

    Cambridge, Cambridgeshire CB2 0AY
    United Kingdom

    Site Not Available

  • Hammersmith Hospital ( Site 1801)

    London, London, City Of W12 OHS
    United Kingdom

    Site Not Available

  • Royal Brompton Hospital ( Site 1804)

    London, London, City Of SW3 6NP
    United Kingdom

    Site Not Available

  • Royal Free London NHS Foundation Trust ( Site 1803)

    London, London, City Of NW3 2QG
    United Kingdom

    Site Not Available

  • Golden Jubilee National Hospital ( Site 1800)

    Glasgow, West Dunbartonshire G81 4DY
    United Kingdom

    Site Not Available

  • Pulmonary Associates, PA ( Site 1903)

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Indiana University Health Methodist Hospital ( Site 1905)

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Kansas Medical Center ( Site 1928)

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Norton Pulmonary Specialists ( Site 1935)

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916)

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • University of Cincinnati Medical Center ( Site 1927)

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Ascension Seton Heart Specialty Care and Transplant Center ( Site 1918)

    Austin, Texas 78705
    United States

    Site Not Available

  • Froedtert Hospital & the Medical College of Wisconsin ( Site 1934)

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.