A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

Last updated: June 25, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Pulmonary Arterial Hypertension

Treatment

Sotatercept

Clinical Study ID

NCT07218029
7962-038
MK-7962-004
MK-7962-038
U1111-1321-4943
2025-521970-33-00
  • Ages > 18
  • All Genders

Study Summary

Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse.

Sotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH.

This is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.

Eligibility Criteria

Inclusion

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has completed their current respective PAH sotatercept clinical study and itsrequirements, and must not have discontinued early

  • Is willing to adhere to the study visit schedule, and understands and will complywith all protocol requirements

  • Must have the ability to understand and provide documented informed consent

Exclusion

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Did not participate in a sotatercept PAH parent study

  • Missed more than the equivalent of 4 consecutive doses between the end of parentstudy and the start of this study.

  • Presence of an ongoing serious adverse event that occurred during a PAH sotaterceptclinical study that is assessed to be possibly or probably related to sotatercept

  • Is a female who is pregnant or breastfeeding

  • Is or has an immediate family member who is investigational site or Sponsor staffdirectly involved with this study

  • Is currently enrolled in another investigational product study other than asotatercept study

  • Is incapacitated

Study Design

Total Participants: 815
Treatment Group(s): 1
Primary Treatment: Sotatercept
Phase: 3
Study Start date:
May 12, 2021
Estimated Completion Date:
December 07, 2028

Study Description

LTFU PAH sotatercept study MK-7962-004 (Obsolete Identifier: NCT04796337) has been incorporated into the current MK-7962-038 (NCT07218029) study for administrative reasons. The MK-7962-004 study is no longer enrolling participants and will be formally closed. Only those who participated in MK-7962-004 may be eligible to continue into MK-7962-038.

Connect with a study center

  • Instituto de Investigaciones Clinicas Quilmes ( Site 1903)

    Quilmes, Buenos Aires B1878GEG
    Argentina

    Site Not Available

  • Instituto Médico Río Cuarto ( Site 1907)

    Río Cuarto, Córdoba Province X5800AEV
    Argentina

    Site Not Available

  • Hospital Provincial del Centenario ( Site 1912)

    Rosario, Santa Fe Province S2002KDS
    Argentina

    Site Not Available

  • Instituto Cardiovascular de Rosario ( Site 1906)

    Rosario, Santa Fe Province S2000DSR
    Argentina

    Site Not Available

  • Sanatorio Parque ( Site 1905)

    Rosario, Santa Fe Province S2000CUB
    Argentina

    Site Not Available

  • Sanatorio Allende ( Site 1908)

    Córdoba, X5021FPQ
    Argentina

    Site Not Available

  • Hospital Provincial Dr. Jose M. Cullen ( Site 1902)

    Santa Fe, S3000EOZ
    Argentina

    Site Not Available

  • Royal Prince Alfred Hospital ( Site 1106)

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • The Prince Charles Hospital ( Site 1104)

    Chermside, New South Wales 4032
    Australia

    Active - Recruiting

  • John Hunter Hospital ( Site 1101)

    New Lambton Heights, New South Wales 2305
    Australia

    Site Not Available

  • Royal Hobart Hospital ( Site 1107)

    Hobart, Tasmania 7000
    Australia

    Active - Recruiting

  • Fiona Stanley Hospital ( Site 1103)

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • Université Libre de Bruxelles - Hôpital Erasme ( Site 1402)

    Brussels, Bruxelles-Capitale, Region de 1070
    Belgium

    Site Not Available

  • UZ Leuven ( Site 1401)

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805)

    Porto Alegre, Rio Grande do Sul 90020-090
    Brazil

    Active - Recruiting

  • Hospital Dia do Pulmao ( Site 1802)

    Blumenau, Santa Catarina 89010-000
    Brazil

    Active - Recruiting

  • Peter Lougheed Centre ( Site 2102)

    Calgary, Alberta T1Y 6J4
    Canada

    Active - Recruiting

  • University of Alberta Hospital ( Site 2101)

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

  • Fundación Neumológica Colombiana ( Site 3403)

    Bogotá, Bogota D.C. 110131
    Colombia

    Site Not Available

  • Clínica Imbanaco S.A.S ( Site 3404)

    Cali, Valle del Cauca Department 760042
    Colombia

    Site Not Available

  • Klinicki Bolnicki Centar Split ( Site 3901)

    Split, Split-Dalmatia County 21000
    Croatia

    Site Not Available

  • Institut Klinicke a Experimentalni Mediciny ( Site 2202)

    Prague, Praha 4 140 21
    Czechia

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze ( Site 2201)

    Prague, 128 08
    Czechia

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze ( Site 2201)

    Prague 3067696, 128 08
    Czechia

    Active - Recruiting

  • Rigshospitalet ( Site 3802)

    København Ø, Capital Region 2100
    Denmark

    Site Not Available

  • Aarhus Universitetshospital, Skejby ( Site 3801)

    Aarhus, Central Jutland 8200
    Denmark

    Site Not Available

  • Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)

    Nice, Alpes-Maritimes 06300
    France

    Active - Recruiting

  • CHU Bordeaux Haut-Leveque ( Site 1312)

    Pessac, Aquitaine 33604
    France

    Active - Recruiting

  • Nouvel Hôpital Civil (NHC) ( Site 1307)

    Strasbourg, Bas-Rhin 67000
    France

    Site Not Available

  • Hopital Cavale Blanche ( Site 1314)

    Brest, Finistere 29609
    France

    Active - Recruiting

  • Hopital Larrey ( Site 1315)

    Toulouse, Haute-Garonne 31400
    France

    Site Not Available

  • Institut Coeur Poumon - CHRU de Lille ( Site 1306)

    Lille, Hauts-de-France 59037
    France

    Active - Recruiting

  • CHU de Grenoble Hopital Nord ( Site 1303)

    La Tronche, Isere 38700
    France

    Site Not Available

  • Hopital Nord Laennec ( Site 1309)

    Saint-Herblain, Loire-Atlantique 44800
    France

    Active - Recruiting

  • CHU Angers ( Site 1313)

    Angers, Maine-et-Loire 49100
    France

    Site Not Available

  • CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE ( Site 1306)

    Lille, Nord 59037
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Saint Étienne- Hôpital Nord-Medecine Vasculaire et Therapeutique ( Site 1302)

    Saint-Étienne-de-Montluc, Pays de la Loire Region 42055
    France

    Active - Recruiting

  • Hôpital Louis Pradel ( Site 1317)

    Lyon, Rhone 69677
    France

    Active - Recruiting

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1304)

    Le Kremlin-Bicêtre, Val-de-Marne 94275
    France

    Active - Recruiting

  • CHU de la Miletrie Poitiers ( Site 1316)

    Poitiers, Vienne 86021
    France

    Active - Recruiting

  • Thoraxklinik-Heidelberg gGmbH ( Site 1509)

    Heidelberg, Baden-Wurttemberg 69126
    Germany

    Site Not Available

  • Krankenhaus Neuwittelsbach ( Site 1510)

    München, Bavaria 80639
    Germany

    Site Not Available

  • Universitaetsklinik Regensburg ( Site 1503)

    Regensburg, Bavaria 93053
    Germany

    Active - Recruiting

  • UKGM Gießen/Marburg ( Site 1512)

    Giessen, Hesse 35392
    Germany

    Active - Recruiting

  • Medizinische Hochschule Hannover ( Site 1505)

    Hanover, Lower Saxony 30625
    Germany

    Active - Recruiting

  • Universitaetsklinikum Koeln ( Site 1511)

    Cologne, North Rhine-Westphalia 50937
    Germany

    Active - Recruiting

  • Universitaetsklinikum Carl Gustav Carus ( Site 1501)

    Dresden, Saxony 01307
    Germany

    Active - Recruiting

  • Universitätsklinikum Leipzig ( Site 1508)

    Leipzig, Saxony 04103
    Germany

    Site Not Available

  • Universitätsklinikum Halle ( Site 1502)

    Halle, Saxony-Anhalt 06120
    Germany

    Active - Recruiting

  • DRK Kliniken Berlin Westend ( Site 1507)

    Berlin, 14050
    Germany

    Site Not Available

  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3604)

    Athens, Attica 124 62
    Greece

    Site Not Available

  • Onassis Cardiac Surgery Center ( Site 3602)

    Athens, Attica 176 74
    Greece

    Active - Recruiting

  • AHEPA University General Hospital of Thessaloniki-1st Cardiology Clinic ( Site 3601)

    Thessaloniki, 546 36
    Greece

    Site Not Available

  • Carmel Hospital ( Site 1705)

    Haifa, 3436212
    Israel

    Site Not Available

  • Haddasah Medical Center ( Site 1711)

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Rabin Medical Center ( Site 1703)

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Sheba Medical Center ( Site 1701)

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • Fondazione IRCCS San Gerardo dei Tintori ( Site 2406)

    Monza, Lombardy 20900
    Italy

    Site Not Available

  • Ospedale San Giuseppe ( Site 2403)

    Milan, Milano 20123
    Italy

    Site Not Available

  • AOU Policlinico Umberto I ( Site 2402)

    Rome, Roma 00161
    Italy

    Site Not Available

  • A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 2407)

    Naples, 80131
    Italy

    Site Not Available

  • Radboud University Nijmegen Medical Centre ( Site 2605)

    Nijmegen, Gelderland 6525 GA
    Netherlands

    Site Not Available

  • Amsterdam UMC, locatie VUmc ( Site 2601)

    Amsterdam, North Holland 1081 HV
    Netherlands

    Site Not Available

  • Waikato Hospital ( Site 2702)

    Hamilton, Waikato Region 3240
    New Zealand

    Site Not Available

  • Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)

    Krakow, Lesser Poland Voivodeship 31-202
    Poland

    Active - Recruiting

  • Europejskie Centrum Zdrowia Otwock ( Site 2802)

    Otwock, Masovian Voivodeship 05-400
    Poland

    Active - Recruiting

  • Hospital Garcia de Orta ( Site 3501)

    Almada, Setúbal District 2805-267
    Portugal

    Active - Recruiting

  • Hospital Pulido Valente ( Site 3503)

    Lisbon, 1769-001
    Portugal

    Active - Recruiting

  • University Clinical Hospital Center of Serbia ( Site 2901)

    Belgrade, Beograd 11000
    Serbia

    Site Not Available

  • Institute for pulmonary diseases of Vojvodina ( Site 2906)

    Novi Sad, Beograd 21000
    Serbia

    Site Not Available

  • Institute for Cardiovascular Diseases Dedinje ( Site 2903)

    Belgrade, 11000
    Serbia

    Site Not Available

  • Gachon University Gil Medical Center ( Site 3103)

    Incheon, 21565
    South Korea

    Site Not Available

  • Samsung Medical Center ( Site 3106)

    Seoul, 06351
    South Korea

    Site Not Available

  • Severance Hospital, Yonsei University Health System ( Site 3101)

    Seoul, 03722
    South Korea

    Site Not Available

  • Samsung Medical Center ( Site 3106)

    Seoul 1835848, 06351
    South Korea

    Site Not Available

  • Hospital Universitario de Son Espases ( Site 1611)

    Palma de Mallorca, Balearic Islands 07120
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla ( Site 1601)

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Universitari Vall D Hebron ( Site 1605)

    Barcelona, Catalonia 08035
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre ( Site 1603)

    Madrid, Madrid, Comunidad de 28041
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre ( Site 1603)

    Madrid 3117735, Madrid, Comunidad de 28041
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona ( Site 1602)

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona ( Site 1602)

    Barcelona 3128760, 08036
    Spain

    Active - Recruiting

  • Hospital General Universitario Ramon y Cajal ( Site 1609)

    Madrid, 28048
    Spain

    Site Not Available

  • Hospital Universitario La Paz ( Site 1610)

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital General Universitario Ramon y Cajal ( Site 1609)

    Madrid 3117735, 28048
    Spain

    Active - Recruiting

  • HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1607)

    Toledo, 45007
    Spain

    Site Not Available

  • Sahlgrenska Universitetssjukhuset ( Site 3201)

    Gothenburg, Västra Götaland County 41346
    Sweden

    Site Not Available

  • UniversitätsSpital Zürich ( Site 3301)

    Zurich, 8091
    Switzerland

    Site Not Available

  • Kaohsiung Veteran General Hospital ( Site 3702)

    Kaohsiung City, 813
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital ( Site 3703)

    Tainan, 704302
    Taiwan

    Site Not Available

  • Papworth Hospital NHS Foundation Trust ( Site 1208)

    Cambridge, Cambridgeshire CB2 0AY
    United Kingdom

    Site Not Available

  • Golden Jubilee National Hospital ( Site 1204)

    Glasgow, Glasgow City G81 4DY
    United Kingdom

    Site Not Available

  • Hammersmith Hospital ( Site 1203)

    London, London, City of W12 0HS
    United Kingdom

    Site Not Available

  • Royal Brompton Hospital ( Site 1206)

    London, London, City of SW3 6NP
    United Kingdom

    Site Not Available

  • Royal Free Hospital ( Site 1202)

    London, London, City of NW3 2QG
    United Kingdom

    Site Not Available

  • Hammersmith Hospital ( Site 1203)

    London 2643743, London, City of W12 0HS
    United Kingdom

    Active - Recruiting

  • Freeman Hospital ( Site 1205)

    Newcastle upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Royal Hallamshire Hospital ( Site 1207)

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

  • Pulmonary Associates, PA ( Site 1008)

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Arizona Pulmonary Specialists ( Site 1010)

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • University of Arizona ( Site 1006)

    Tucson, Arizona 85724-0001
    United States

    Active - Recruiting

  • University of California San Diego Health ( Site 1002)

    La Jolla, California 92039
    United States

    Site Not Available

  • UC Irvine Health Medical Center ( Site 1086)

    Orange, California 92868
    United States

    Site Not Available

  • UC Davis - Medial Center ( Site 1064)

    Sacramento, California 95817
    United States

    Active - Recruiting

  • UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019)

    San Francisco, California 94143
    United States

    Site Not Available

  • Jeffrey S. Sager, MD Medical Corporation ( Site 1060)

    Santa Barbara, California 93105-5316
    United States

    Active - Recruiting

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)

    Torrance, California 90502
    United States

    Site Not Available

  • University of Colorado Hospital ( Site 1013)

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Mayo Clinic Jacksonville ( Site 1045)

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • AdventHealth Orlando ( Site 1058)

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Tampa General Hospital ( Site 1043)

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • University of Kansas Medical Center ( Site 1020)

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Norton Pulmonary Specialists ( Site 1066)

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Johns Hopkins University ( Site 1036)

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Brigham and Women's Hospital ( Site 1014)

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Tufts Medical Center ( Site 1012)

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • University of Minnesota ( Site 1062)

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • University Of Nebraska Medical Center ( Site 1053)

    Omaha, Nebraska 68198-5990
    United States

    Site Not Available

  • Weill Cornell Medical Center ( Site 1046)

    New York, New York 10021
    United States

    Site Not Available

  • Duke University Medical Center ( Site 1026)

    Durham, North Carolina 27710-4000
    United States

    Active - Recruiting

  • The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • University of Cincinnati Medical Center ( Site 1035)

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Cleveland Clinic Main ( Site 1065)

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Ohio State University Wexner Medical Center ( Site 1032)

    Columbus, Ohio 43210
    United States

    Site Not Available

  • The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Active - Recruiting

  • Oregon Health & Science University ( Site 1054)

    Portland, Oregon 97239
    United States

    Site Not Available

  • University of Pittsburgh Medical Center - Presbyterian Hosp. ( Site 1059)

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Rhode Island Hospital ( Site 1033)

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Medical University of South Carolina ( Site 1003)

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center ( Site 1038)

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Houston Methodist Hospital ( Site 1009)

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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