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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified May 2026 by Merck Sharp & Dohme LLC
Sponsor
Merck Sharp & Dohme LLC
Information Provided by (Responsible Party)
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
NCT07218029
Other Study ID Numbers:
7962-038
First Submitted
October 6, 2025
First Posted
October 19, 2025
Last Update Posted
June 25, 2026
Last Verified
May 2026

ClinicalTrials.gov processed this data on June 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

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.

Condition or DiseaseIntervention/Treatment
Pulmonary Arterial Hypertension
Biological: Sotatercept

Study Design

Study TypeInterventional
Actual Enrollment815 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)
Study Start DateMay 11, 2021
Actual Primary Completion Date2yrs 5mos from now
Actual Study Completion Date2yrs 5mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Sotatercept
Participants enrolling from blinded PAH sotatercept studies will begin sotatercept at a dose of 0.3 mg/kg subcutaneous (SC) injection and can titrate up to the target dose of 0.7 mg/kg SC injection for the remainder of the study. Participants enrolling from unblinded PAH sotatercept studies will continue sotatercept at their current dose and, if at a dose \<0.7 mg/kg, can titrate up to the target dose of 0.7 mg/kg SC injection for the remainder of the study.
Biological: Sotatercept
Sotatercept SC injection every 3 weeks

Outcome Measures

Primary Outcome Measures
  1. Number of Participants Who Experience an Adverse Event (AE)
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
  2. Number of Participants Who Discontinue Study Treatment Due to an AE
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
  3. Number of Participants with Detectable Anti-Drug Antibodies (ADAs)
    ADAs will be detected in serum. The number of participants with detectable ADAs will be reported.
  4. Laboratory parameters (Hematology): Concentration of Platelets and Hemoglobin
    Blood samples will be collected to determine the concentration of platelets and hemoglobin.
  5. Laboratory parameters (Chemistry): Concentration of Creatinine, Total Bilirubin, and Alanine Aminotransferase (ALT)
    Blood samples will be collected to determine the concentration of creatinine, total bilirubin, and ALT.
  6. Change From Baseline in Body Weight
    Change from baseline in body weight will be reported.
  7. Change From Baseline in Blood Pressure
    Change from baseline in systolic and diastolic blood pressure will be reported.
  8. Change From Baseline in Electrocardiogram (ECG)
    Change from baseline in ECG (12-lead) for the determination of Fridericia&#039;s corrected QT interval (QTcF) will be reported.
Secondary Outcome Measures
  1. Change From Baseline in 6-Minute Walk Distance (6MWD)
    The 6MWD is the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD will be reported.
  2. Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels
    NT-proBNP is a circulating biomarker that reflects myocardial stretch. The change from baseline in NT-proBNP levels will be reported.
  3. Change From Baseline in the Percentage of Participants Who Improve or Show Maintenance in Modified New York Heart Association/ World Health Organization Classification of Functional Status (WHO FC)
    The severity of participant&#039;s PAH symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform physical activity without any symptoms, dyspnea at rest). Participants will be classified as &quot;Improved&quot;, &quot;No change&quot;, or &quot;Worsened&quot;. Improved = reduction in WHO FC; No Change = no change in WHO FC; Worsened = increase in WHO FC. The change from baseline in the percentage of participants who improve or show maintenance in WHO FC will be reported.
  4. Change From Baseline in Pulmonary Vascular Resistance (PVR)
    PVR is a hemodynamic variable of pulmonary circulation and is measured by right heart catheterization. The change from baseline in PVR will be reported.
  5. Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator
    The simplified French Risk scoring system is based on the 2015 European Society of Cardiology/European Respiratory Society guidelines for the diagnosis and treatment of pulmonary hypertension (PH). Noninvasive parameters (WHO FC, 6MWD, NT-proBNP levels) will be used to determine the score. &#039;Low risk&#039; is defined as maintaining or achieving all 3 low-risk criteria: WHO FC I or II, 6MWD \&gt;440 meters, and NT-proBNP \&lt;300 ng/L. The change from baseline in percentage of participants who maintain or achieve a low risk simplified French Risk score will be reported.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
The main inclusion criteria include but are not limited to the following:
Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements
Must have the ability to understand and provide documented informed consent
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 parent study and the start of this study.
Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical 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 staff directly involved with this study
Is currently enrolled in another investigational product study other than a sotatercept study
Is incapacitated

Contacts and Locations

Sponsors and CollaboratorsMerck Sharp & Dohme LLC
Locations
Pulmonary Associates, PA ( Site 1008) | Phoenix Arizona, United States, 85032Arizona Pulmonary Specialists ( Site 1010) | Scottsdale Arizona, United States, 85258University of Arizona ( Site 1006) | Tucson Arizona, United States, 85724-0001University of California San Diego Health ( Site 1002) | La Jolla California, United States, 92039UC Irvine Health Medical Center ( Site 1086) | Orange California, United States, 92868UC Davis - Medial Center ( Site 1064) | Sacramento California, United States, 95817UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019) | San Francisco California, United States, 94143Jeffrey S. Sager, MD Medical Corporation ( Site 1060) | Santa Barbara California, United States, 93105-5316Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028) | Torrance California, United States, 90502University of Colorado Hospital ( Site 1013) | Aurora Colorado, United States, 80045Mayo Clinic Jacksonville ( Site 1045) | Jacksonville Florida, United States, 32224AdventHealth Orlando ( Site 1058) | Orlando Florida, United States, 32803Tampa General Hospital ( Site 1043) | Tampa Florida, United States, 33606University of Kansas Medical Center ( Site 1020) | Kansas City Kansas, United States, 66160Norton Pulmonary Specialists ( Site 1066) | Louisville Kentucky, United States, 40202Johns Hopkins University ( Site 1036) | Baltimore Maryland, United States, 21287Tufts Medical Center ( Site 1012) | Boston Massachusetts, United States, 02111Brigham and Women's Hospital ( Site 1014) | Boston Massachusetts, United States, 02115University of Minnesota ( Site 1062) | Minneapolis Minnesota, United States, 55455University Of Nebraska Medical Center ( Site 1053) | Omaha Nebraska, United States, 68198-5990Weill Cornell Medical Center ( Site 1046) | New York New York, United States, 10021Duke University Medical Center ( Site 1026) | Durham North Carolina, United States, 27710-4000The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001) | Cincinnati Ohio, United States, 45219University of Cincinnati Medical Center ( Site 1035) | Cincinnati Ohio, United States, 45219Cleveland Clinic Main ( Site 1065) | Cleveland Ohio, United States, 44195Ohio State University Wexner Medical Center ( Site 1032) | Columbus Ohio, United States, 43210Oregon Health & Science University ( Site 1054) | Portland Oregon, United States, 97239University of Pittsburgh Medical Center - Presbyterian Hosp. ( Site 1059) | Pittsburgh Pennsylvania, United States, 15213Rhode Island Hospital ( Site 1033) | Providence Rhode Island, United States, 02903Medical University of South Carolina ( Site 1003) | Charleston South Carolina, United States, 29425University of Texas Southwestern Medical Center ( Site 1038) | Dallas Texas, United States, 75390CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044) | Houston Texas, United States, 77030Houston Methodist Hospital ( Site 1009) | Houston Texas, United States, 77030Froedtert Hospital & the Medical College of Wisconsin ( Site 1051) | Milwaukee Wisconsin, United States, 53226Instituto de Investigaciones Clinicas Quilmes ( Site 1903) | Quilmes Buenos Aires, Argentina, B1878GEGInstituto Médico Río Cuarto ( Site 1907) | Río Cuarto Córdoba Province, Argentina, X5800AEVSanatorio Parque ( Site 1905) | Rosario Santa Fe Province, Argentina, S2000CUBInstituto Cardiovascular de Rosario ( Site 1906) | Rosario Santa Fe Province, Argentina, S2000DSRHospital Provincial del Centenario ( Site 1912) | Rosario Santa Fe Province, Argentina, S2002KDSSanatorio Allende ( Site 1908) | Córdoba , Argentina, X5021FPQHospital Provincial Dr. Jose M. Cullen ( Site 1902) | Santa Fe , Argentina, S3000EOZRoyal Prince Alfred Hospital ( Site 1106) | Camperdown New South Wales, Australia, 2050The Prince Charles Hospital ( Site 1104) | Chermside New South Wales, Australia, 4032John Hunter Hospital ( Site 1101) | New Lambton Heights New South Wales, Australia, 2305Royal Hobart Hospital ( Site 1107) | Hobart Tasmania, Australia, 7000Fiona Stanley Hospital ( Site 1103) | Murdoch Western Australia, Australia, 6150Université Libre de Bruxelles - Hôpital Erasme ( Site 1402) | Brussels Bruxelles-Capitale, Region de, Belgium, 1070UZ Leuven ( Site 1401) | Leuven Vlaams-Brabant, Belgium, 3000Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805) | Porto Alegre Rio Grande do Sul, Brazil, 90020-090Hospital Dia do Pulmao ( Site 1802) | Blumenau Santa Catarina, Brazil, 89010-000Peter Lougheed Centre ( Site 2102) | Calgary Alberta, Canada, T1Y 6J4University of Alberta Hospital ( Site 2101) | Edmonton Alberta, Canada, T6G 2B7Fundación Neumológica Colombiana ( Site 3403) | Bogotá Bogota D.C., Colombia, 110131Clínica Imbanaco S.A.S ( Site 3404) | Cali Valle del Cauca Department, Colombia, 760042Klinicki Bolnicki Centar Split ( Site 3901) | Split Split-Dalmatia County, Croatia, 21000Institut Klinicke a Experimentalni Mediciny ( Site 2202) | Prague Praha 4, Czechia, 140 21Vseobecna fakultni nemocnice v Praze ( Site 2201) | Prague , Czechia, 128 08Rigshospitalet ( Site 3802) | København Ø Capital Region, Denmark, 2100Aarhus Universitetshospital, Skejby ( Site 3801) | Aarhus Central Jutland, Denmark, 8200Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311) | Nice Alpes-Maritimes, France, 06300CHU Bordeaux Haut-Leveque ( Site 1312) | Pessac Aquitaine, France, 33604Nouvel Hôpital Civil (NHC) ( Site 1307) | Strasbourg Bas-Rhin, France, 67000Hopital Cavale Blanche ( Site 1314) | Brest Finistere, France, 29609Hopital Larrey ( Site 1315) | Toulouse Haute-Garonne, France, 31400CHU de Grenoble Hopital Nord ( Site 1303) | La Tronche Isere, France, 38700Hopital Nord Laennec ( Site 1309) | Saint-Herblain Loire-Atlantique, France, 44800CHU Angers ( Site 1313) | Angers Maine-et-Loire, France, 49100CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE ( Site 1306) | Lille Nord, France, 59037Centre Hospitalier Universitaire de Saint Étienne- Hôpital Nord-Medecine Vasculaire et Therapeutique ( Site 1302) | Saint-Étienne-de-Montluc Pays de la Loire Region, France, 42055Hôpital Louis Pradel ( Site 1317) | Lyon Rhone, France, 69677Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1304) | Le Kremlin-Bicêtre Val-de-Marne, France, 94275CHU de la Miletrie Poitiers ( Site 1316) | Poitiers Vienne, France, 86021Thoraxklinik-Heidelberg gGmbH ( Site 1509) | Heidelberg Baden-Wurttemberg, Germany, 69126Krankenhaus Neuwittelsbach ( Site 1510) | München Bavaria, Germany, 80639Universitaetsklinik Regensburg ( Site 1503) | Regensburg Bavaria, Germany, 93053UKGM Gießen/Marburg ( Site 1512) | Giessen Hesse, Germany, 35392Medizinische Hochschule Hannover ( Site 1505) | Hanover Lower Saxony, Germany, 30625Universitaetsklinikum Koeln ( Site 1511) | Cologne North Rhine-Westphalia, Germany, 50937Universitaetsklinikum Carl Gustav Carus ( Site 1501) | Dresden Saxony, Germany, 01307Universitätsklinikum Leipzig ( Site 1508) | Leipzig Saxony, Germany, 04103Universitätsklinikum Halle ( Site 1502) | Halle Saxony-Anhalt, Germany, 06120DRK Kliniken Berlin Westend ( Site 1507) | Berlin , Germany, 14050ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3604) | Athens Attica, Greece, 124 62Onassis Cardiac Surgery Center ( Site 3602) | Athens Attica, Greece, 176 74AHEPA University General Hospital of Thessaloniki-1st Cardiology Clinic ( Site 3601) | Thessaloniki , Greece, 546 36Carmel Hospital ( Site 1705) | Haifa , Israel, 3436212Haddasah Medical Center ( Site 1711) | Jerusalem , Israel, 9112001Rabin Medical Center ( Site 1703) | Petah Tikva , Israel, 4941492Sheba Medical Center ( Site 1701) | Ramat Gan , Israel, 5265601Fondazione IRCCS San Gerardo dei Tintori ( Site 2406) | Monza Lombardy, Italy, 20900Ospedale San Giuseppe ( Site 2403) | Milan Milano, Italy, 20123AOU Policlinico Umberto I ( Site 2402) | Rome Roma, Italy, 00161A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 2407) | Naples , Italy, 80131Radboud University Nijmegen Medical Centre ( Site 2605) | Nijmegen Gelderland, Netherlands, 6525 GAAmsterdam UMC, locatie VUmc ( Site 2601) | Amsterdam North Holland, Netherlands, 1081 HVWaikato Hospital ( Site 2702) | Hamilton Waikato Region, New Zealand, 3240Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801) | Krakow Lesser Poland Voivodeship, Poland, 31-202Europejskie Centrum Zdrowia Otwock ( Site 2802) | Otwock Masovian Voivodeship, Poland, 05-400Hospital Garcia de Orta ( Site 3501) | Almada Setúbal District, Portugal, 2805-267Hospital Pulido Valente ( Site 3503) | Lisbon , Portugal, 1769-001University Clinical Hospital Center of Serbia ( Site 2901) | Belgrade Beograd, Serbia, 11000Institute for pulmonary diseases of Vojvodina ( Site 2906) | Novi Sad Beograd, Serbia, 21000Institute for Cardiovascular Diseases Dedinje ( Site 2903) | Belgrade , Serbia, 11000Gachon University Gil Medical Center ( Site 3103) | Incheon , South Korea, 21565Severance Hospital, Yonsei University Health System ( Site 3101) | Seoul , South Korea, 03722Samsung Medical Center ( Site 3106) | Seoul , South Korea, 06351Hospital Universitario de Son Espases ( Site 1611) | Palma de Mallorca Balearic Islands, Spain, 07120Hospital Universitario Marques de Valdecilla ( Site 1601) | Santander Cantabria, Spain, 39008Hospital Universitari Vall D Hebron ( Site 1605) | Barcelona Catalonia, Spain, 08035Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604) | Majadahonda Madrid, Spain, 28222Hospital Universitario 12 de Octubre ( Site 1603) | Madrid Madrid, Comunidad de, Spain, 28041Hospital Clinic de Barcelona ( Site 1602) | Barcelona , Spain, 08036Hospital Universitario La Paz ( Site 1610) | Madrid , Spain, 28046Hospital General Universitario Ramon y Cajal ( Site 1609) | Madrid , Spain, 28048HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1607) | Toledo , Spain, 45007Sahlgrenska Universitetssjukhuset ( Site 3201) | Gothenburg Västra Götaland County, Sweden, 41346UniversitätsSpital Zürich ( Site 3301) | Zurich , Switzerland, 8091Kaohsiung Veteran General Hospital ( Site 3702) | Kaohsiung City , Taiwan, 813National Cheng Kung University Hospital ( Site 3703) | Tainan , Taiwan, 704302Papworth Hospital NHS Foundation Trust ( Site 1208) | Cambridge Cambridgeshire, United Kingdom, CB2 0AYGolden Jubilee National Hospital ( Site 1204) | Glasgow Glasgow City, United Kingdom, G81 4DYRoyal Free Hospital ( Site 1202) | London London, City of, United Kingdom, NW3 2QGRoyal Brompton Hospital ( Site 1206) | London London, City of, United Kingdom, SW3 6NPHammersmith Hospital ( Site 1203) | London London, City of, United Kingdom, W12 0HSFreeman Hospital ( Site 1205) | Newcastle upon Tyne , United Kingdom, NE7 7DNRoyal Hallamshire Hospital ( Site 1207) | Sheffield , United Kingdom, S10 2JF
Investigators
Study Director: Medical Director, Merck Sharp & Dohme LLC