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

Last updated: April 6, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Vascular Diseases

Williams Syndrome

Pulmonary Arterial Hypertension

Treatment

Background PAH Therapy

Sotatercept

Clinical Study ID

NCT06664801
7962-024
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: Background PAH Therapy
Phase: 2
Study Start date:
November 14, 2024
Estimated Completion Date:
July 10, 2026

Connect with a study center

  • Centro Medico Capital ( Site 0002)

    La Plata, Buenos Aires B1904AAW
    Argentina

    Active - Recruiting

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

    Mar del plata, Buenos Aires B7600FZO
    Argentina

    Active - Recruiting

  • Instituto Medico Rio Cuarto ( Site 0010)

    Rio Cuarto, Cordoba X5800AEV
    Argentina

    Active - Recruiting

  • Hospital Britanico de Buenos Aires ( Site 0004)

    Caba, C1280AEB
    Argentina

    Active - Recruiting

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

    Corrientes, W3400AMZ
    Argentina

    Active - Recruiting

  • Hospital Provincial Jose Maria Cullen ( Site 0005)

    Santa Fe, 3000
    Argentina

    Active - Recruiting

  • Royal Prince Alfred Hospital ( Site 0103)

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Westmead Hospital ( Site 0100)

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Wesley Research Institute ( Site 0101)

    Auchenflower, Queensland 4066
    Australia

    Active - Recruiting

  • The Alfred Hospital ( Site 0102)

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Peter Lougheed Centre ( Site 0203)

    Calgary, Alberta T1Y 6J4
    Canada

    Active - Recruiting

  • IUCPQ ( Site 0208)

    Quebec, G1V 4G5
    Canada

    Active - Recruiting

  • 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

    Active - Recruiting

  • Shanghai Pulmonary Hospital ( Site 2004)

    Shanghai, Shanghai 200433
    China

    Active - Recruiting

  • Yan an Hospital of Kunming City ( Site 2011)

    Kunming, Yunnan 650051
    China

    Active - Recruiting

  • Clinica Cardio VID ( Site 0307)

    Medellín, Antioquia 050034
    Colombia

    Active - Recruiting

  • Oncomedica S.A. ( Site 0301)

    Monteria, Cordoba 230002
    Colombia

    Active - Recruiting

  • Fundacion Santa Fe de Bogota ( Site 0302)

    Bogota, Cundinamarca 110111
    Colombia

    Active - Recruiting

  • Clinica Colsanitas - Sede Reina Sofia ( Site 0303)

    Bogota, Distrito Capital De Bogota 110111
    Colombia

    Active - Recruiting

  • Centro de Investigaciones Clinicas SAS ( Site 0306)

    Cali, Valle Del Cauca 760036
    Colombia

    Active - Recruiting

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

    Cali, Valle Del Cauca 760042
    Colombia

    Active - Recruiting

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

    Prague, Praha 2 128 08
    Czechia

    Active - Recruiting

  • CHU Bordeaux Haut-Leveque ( Site 0501)

    Pessac, Aquitaine 33604
    France

    Active - Recruiting

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

    Marseille, Bouches-du-Rhone 13015
    France

    Active - Recruiting

  • CHU Dijon Bourgogne ( Site 0502)

    Dijon, Cote-d Or 2100
    France

    Active - Recruiting

  • CHU de Rouen ( Site 0503)

    Rouen, Haute-Normandie 76000
    France

    Active - Recruiting

  • CHU GABRIEL MONTPIED ( Site 0504)

    Clermont-Ferrand, Puy-de-Dome 63003
    France

    Active - Recruiting

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

    Heidelberg, Baden-Wurttemberg 69126
    Germany

    Active - Recruiting

  • Klinikum der Universität München Großhadern ( Site 0611)

    Munchen, Bayern 81377
    Germany

    Active - Recruiting

  • Medizinische Hochschule Hannover ( Site 0604)

    Hannover, Niedersachsen 30625
    Germany

    Active - Recruiting

  • Universitätsklinikum Bonn ( Site 0608)

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Active - Recruiting

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0609)

    Berlin, 10117
    Germany

    Active - Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf ( Site 0610)

    Hamburg, 20246
    Germany

    Active - Recruiting

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

    Szeged, Csongrad 6725
    Hungary

    Active - Recruiting

  • Pécsi Tudományegyetem Klinikai Központ ( Site 0703)

    Pécs, Pecs 7624
    Hungary

    Active - Recruiting

  • Semmelweis Egyetem ( Site 0701)

    Budapest, Pest 1083
    Hungary

    Active - Recruiting

  • Gottsegen Gyorgy Orszagos Kardiologiai Intezet ( Site 0702)

    Budapest, 1096
    Hungary

    Active - Recruiting

  • Carmel Hospital ( Site 0803)

    Haifa, 3436212
    Israel

    Active - Recruiting

  • Rambam Health Care Campus ( Site 0802)

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Rabin Medical Center ( Site 0805)

    Petah-Tikva, 4941492
    Israel

    Active - Recruiting

  • Sheba Medical Center ( Site 0801)

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

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

    Bologna, Emilia-Romagna 40138
    Italy

    Active - Recruiting

  • AOU Policlinico Umberto I ( Site 0910)

    Roma, Lazio 00161
    Italy

    Active - Recruiting

  • Ospedale San Martino ( Site 0901)

    Genova, Liguria 16132
    Italy

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0900)

    Milan, Lombardia 20162
    Italy

    Active - Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori ( Site 0911)

    Monza, Lombardia 20900
    Italy

    Active - Recruiting

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

    Torino, Piemonte 10126
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata ( Site 0908)

    Verona, Veneto 37126
    Italy

    Active - Recruiting

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

    Milano, 20122
    Italy

    Active - Recruiting

  • Fondazione IRCCS Policlinico San Matteo ( Site 0909)

    Pavia, 27100
    Italy

    Active - Recruiting

  • Fondazione G. Monasterio ( Site 0907)

    Pisa, 56124
    Italy

    Active - Recruiting

  • Ospedale Civile SS Annunziata ( Site 0903)

    Sassari, 07100
    Italy

    Active - Recruiting

  • Nagoya University Hospital ( Site 2102)

    Nagoya, Aichi 466-8560
    Japan

    Active - Recruiting

  • National Cerebral and Cardiovascular Center ( Site 2103)

    Suita, Osaka 564-8565
    Japan

    Active - Recruiting

  • The University of Tokyo Hospital ( Site 2101)

    Bunkyo, Tokyo 113-8655
    Japan

    Active - Recruiting

  • Kyorin University Hospital ( Site 2100)

    Mitaka, Tokyo 181-8611
    Japan

    Site Not Available

  • Kyushu University Hospital ( Site 2105)

    Fukuoka, 812-8582
    Japan

    Active - Recruiting

  • 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

    Active - Recruiting

  • Pusan National University Hospital ( Site 1305)

    Busan, Pusan-Kwangyokshi 49241
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center ( Site 1303)

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center ( Site 1301)

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital ( Site 1302)

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System ( Site 1300)

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Radboud University Medical Center ( Site 1001)

    Nijmegen, Gelderland 6525 GA
    Netherlands

    Active - Recruiting

  • Sint Antonius Ziekenhuis ( Site 1000)

    Nieuwegein, Utrecht 3435CM
    Netherlands

    Active - Recruiting

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

    Krakow, Malopolskie 31-202
    Poland

    Active - Recruiting

  • National Heart Centre Singapore ( Site 1201)

    Singapore, Central Singapore 169609
    Singapore

    Active - Recruiting

  • National University Heart Centre, Singapore ( Site 1200)

    Singapore, Central Singapore 119074
    Singapore

    Active - Recruiting

  • Hospital Universitari Son Espases ( Site 1412)

    Palma, Baleares 07120
    Spain

    Active - Recruiting

  • Hospital Marques de Valdecilla ( Site 1405)

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona ( Site 1406)

    Barcelona, Cataluna 08036
    Spain

    Active - Recruiting

  • Hospital Vall D Hebron ( Site 1404)

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital General Universitario 12 de Octubre ( Site 1403)

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Ramon y Cajal ( Site 1401)

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz ( Site 1410)

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Virgen del Rocio ( Site 1407)

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario de Toledo ( Site 1408)

    Toledo, 45007
    Spain

    Active - Recruiting

  • Kaohsiung Veterans General Hospital ( Site 1503)

    Kaohsiung, 813414
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital ( Site 1501)

    Tainan, 70403
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital ( Site 1502)

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 1600)

    Bangkok, Krung Thep Maha Nakhon 10700
    Thailand

    Active - Recruiting

  • Maharaj Nakorn Chiang Mai Hospital ( Site 1601)

    Chiang Mai, 50200
    Thailand

    Active - Recruiting

  • 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

    Active - Recruiting

  • Hammersmith Hospital ( Site 1801)

    London, London, City Of W12 OHS
    United Kingdom

    Active - Recruiting

  • Royal Brompton Hospital ( Site 1804)

    London, London, City Of SW3 6NP
    United Kingdom

    Active - Recruiting

  • Royal Free London NHS Foundation Trust ( Site 1803)

    London, London, City Of NW3 2QG
    United Kingdom

    Active - Recruiting

  • Golden Jubilee National Hospital ( Site 1800)

    Glasgow, West Dunbartonshire G81 4DY
    United Kingdom

    Active - Recruiting

  • Pulmonary Associates, PA ( Site 1903)

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

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

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Indiana University Health Methodist Hospital ( Site 1905)

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • University of Kansas Medical Center ( Site 1928)

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Norton Pulmonary Specialists ( Site 1935)

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

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

    Albuquerque, New Mexico 87131
    United States

    Active - Recruiting

  • University of Cincinnati Medical Center ( Site 1927)

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

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

    Austin, Texas 78705
    United States

    Active - Recruiting

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

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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