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

NCT07218029 | Recruiting Phase 3 DMC FDA Drug

• 5 other identifiers: 7962-0382025-521970-33-00U1111-1321-4943MK-7962-038MK-7962-004
• Study Type: interventional
• Target: 815
• Locations: 20 countries
• Sites: 81

Brief 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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (8)

• 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.

  Up to approximately 90 months

• 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.

  Up to approximately 86 months

• 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.

  Up to approximately 88 months

• Laboratory parameters (Hematology): Concentration of Platelets and Hemoglobin

  Blood samples will be collected to determine the concentration of platelets and hemoglobin.

  Up to approximately 88 months

• 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.

  Up to approximately 86 months

• Change From Baseline in Body Weight

  Change from baseline in body weight will be reported.

  Baseline and up to approximately 86 months

• Change From Baseline in Blood Pressure

  Change from baseline in systolic and diastolic blood pressure will be reported.

  Baseline and up to approximately 86 months

• Change From Baseline in Electrocardiogram (ECG)

  Change from baseline in ECG (12-lead) for the determination of Fridericia's corrected QT interval (QTcF) will be reported.

  Baseline and up to approximately 86 months

Secondary Outcomes (5)

• Change From Baseline in 6-Minute Walk Distance (6MWD)

  Baseline and up to approximately 48 months

• Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels

  Baseline and up to approximately 48 months

• 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)

  Baseline and up to approximately 48 months

• Change From Baseline in Pulmonary Vascular Resistance (PVR)

  Baseline and up to approximately 48 months

• Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator

  Baseline and up to approximately 48 months

Study Arms (1)

Sotatercept

EXPERIMENTAL

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

Interventions

Sotatercept BIOLOGICAL

Sotatercept SC injection every 3 weeks

Also known as: MK-7962, ACE-011, ActRIIA-IgG1Fc, WINREVAIR®

Sotatercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (81)

Pulmonary Associates, PA ( Site 1008)

Phoenix, Arizona, 85032, United States

ACTIVE NOT RECRUITING

University of California San Diego Health ( Site 1002)

La Jolla, California, 92039, United States

RECRUITING

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

San Francisco, California, 94143, United States

RECRUITING

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

Santa Barbara, California, 93105-5316, United States

RECRUITING

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

Torrance, California, 90502, United States

RECRUITING

University of Colorado Hospital ( Site 1013)

Aurora, Colorado, 80045, United States

ACTIVE NOT RECRUITING

Mayo Clinic Jacksonville ( Site 1045)

Jacksonville, Florida, 32224, United States

RECRUITING

AdventHealth Orlando ( Site 1058)

Orlando, Florida, 32803, United States

RECRUITING

University of Kansas Medical Center ( Site 1020)

Kansas City, Kansas, 66160, United States

RECRUITING

Norton Pulmonary Specialists ( Site 1066)

Louisville, Kentucky, 40202, United States

RECRUITING

Tufts Medical Center ( Site 1012)

Boston, Massachusetts, 02111, United States

RECRUITING

University Of Nebraska Medical Center ( Site 1053)

Omaha, Nebraska, 68198-5990, United States

RECRUITING

Weill Cornell Medical Center ( Site 1046)

New York, New York, 10021, United States

ACTIVE NOT RECRUITING

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

Cincinnati, Ohio, 45219, United States

RECRUITING

University of Cincinnati Medical Center ( Site 1035)

Cincinnati, Ohio, 45219, United States

RECRUITING

Ohio State University Wexner Medical Center ( Site 1032)

Columbus, Ohio, 43210, United States

ACTIVE NOT RECRUITING

Oregon Health & Science University ( Site 1054)

Portland, Oregon, 97239, United States

RECRUITING

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

Houston, Texas, 77030, United States

RECRUITING

Instituto de Investigaciones Clinicas Quilmes ( Site 1903)

Quilmes, Buenos Aires, B1878GEG, Argentina

RECRUITING

Instituto Médico Río Cuarto ( Site 1907)

Río Cuarto, Córdoba Province, X5800AEV, Argentina

RECRUITING

Instituto Cardiovascular de Rosario ( Site 1906)

Rosario, Santa Fe Province, S2000DSR, Argentina

RECRUITING

Sanatorio Parque ( Site 1905)

Rosario, Santa Fe Province, S2000DSV, Argentina

RECRUITING

Sanatorio Allende ( Site 1908)

Córdoba, X5021FPQ, Argentina

RECRUITING

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

Santa Fe, S3000EOZ, Argentina

RECRUITING

Royal Prince Alfred Hospital ( Site 1106)

Camperdown, New South Wales, 2050, Australia

RECRUITING

John Hunter Hospital ( Site 1101)

New Lambton Heights, New South Wales, 2305, Australia

ACTIVE NOT RECRUITING

Royal Hobart Hospital ( Site 1107)

Hobart, Tasmania, 7000, Australia

RECRUITING

Fiona Stanley Hospital ( Site 1103)

Murdoch, Western Australia, 6150, Australia

RECRUITING

Université Libre de Bruxelles - Hôpital Erasme ( Site 1402)

Brussels, Bruxelles-Capitale, Region de, 1070, Belgium

RECRUITING

UZ Leuven ( Site 1401)

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Clínica Imbanaco S.A.S ( Site 3404)

Cali, Valle del Cauca Department, 760042, Colombia

RECRUITING

Institut Klinicke a Experimentalni Mediciny ( Site 2202)

Prague, Praha 4, 140 21, Czechia

RECRUITING

Vseobecna fakultni nemocnice v Praze ( Site 2201)

Prague, 128 08, Czechia

RECRUITING

Rigshospitalet ( Site 3802)

København Ø, Capital Region, 2100, Denmark

ACTIVE NOT RECRUITING

Aarhus Universitetshospital, Skejby ( Site 3801)

Aarhus, Central Jutland, 8200, Denmark

ACTIVE NOT RECRUITING

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

Nice, Alpes-Maritimes, 06300, France

RECRUITING

Nouvel Hôpital Civil (NHC) ( Site 1307)

Strasbourg, Bas-Rhin, 67000, France

RECRUITING

Hopital Cavale Blanche ( Site 1314)

Brest, Finistere, 29609, France

RECRUITING

Hopital Larrey ( Site 1315)

Toulouse, Haute-Garonne, 31400, France

RECRUITING

Institut Coeur Poumon - CHRU de Lille ( Site 1306)

Lille, Hauts-de-France, 59037, France

RECRUITING

CHU de Grenoble Hopital Nord ( Site 1303)

La Tronche, Isere, 38700, France

RECRUITING

Hopital Nord Laennec ( Site 1309)

Saint-Herblain, Loire-Atlantique, 44800, France

RECRUITING

CHU Angers ( Site 1313)

Angers, Maine-et-Loire, 49100, France

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

RECRUITING

Hôpital Louis Pradel ( Site 1317)

Lyon, Rhone, 69677, France

RECRUITING

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

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

RECRUITING

CHU de la Miletrie Poitiers ( Site 1316)

Poitiers, Vienne, 86021, France

RECRUITING

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

Thessaloniki, 546 36, Greece

RECRUITING

Carmel Hospital ( Site 1705)

Haifa, 3436212, Israel

RECRUITING

Haddasah Medical Center ( Site 1711)

Jerusalem, 9112001, Israel

RECRUITING

Rabin Medical Center ( Site 1703)

Petah Tikva, 4941492, Israel

RECRUITING

Sheba Medical Center ( Site 1701)

Ramat Gan, 5265601, Israel

RECRUITING

Ospedale San Giuseppe ( Site 2403)

Milan, Milano, 20123, Italy

RECRUITING

AOU Policlinico Umberto I ( Site 2402)

Rome, Roma, 00161, Italy

RECRUITING

Radboud University Nijmegen Medical Centre ( Site 2605)

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Amsterdam UMC, locatie VUmc ( Site 2601)

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

Waikato Hospital ( Site 2702)

Hamilton, Waikato Region, 3240, New Zealand

ACTIVE NOT RECRUITING

Hospital Garcia de Orta ( Site 3501)

Almada, Setúbal District, 2805-267, Portugal

RECRUITING

Gachon University Gil Medical Center ( Site 3103)

Incheon, 21565, South Korea

ACTIVE NOT RECRUITING

Severance Hospital, Yonsei University Health System ( Site 3101)

Seoul, 03722, South Korea

ACTIVE NOT RECRUITING

Samsung Medical Center ( Site 3106)

Seoul, 06351, South Korea

ACTIVE NOT RECRUITING

Hospital Universitario de Son Espases ( Site 1611)

Palma de Mallorca, Balearic Islands, 07120, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Marques de Valdecilla ( Site 1601)

Santander, Cantabria, 39008, Spain

ACTIVE NOT RECRUITING

Hospital Universitari Vall D Hebron ( Site 1605)

Barcelona, Catalonia, 08035, Spain

RECRUITING

Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)

Majadahonda, Madrid, 28222, Spain

RECRUITING

Hospital Universitario 12 de Octubre ( Site 1603)

Madrid, Madrid, Comunidad de, 28041, Spain

RECRUITING

Hospital Clinic de Barcelona ( Site 1602)

Barcelona, 08036, Spain

ACTIVE NOT RECRUITING

Hospital Universitario La Paz ( Site 1610)

Madrid, 28046, Spain

ACTIVE NOT RECRUITING

Hospital General Universitario Ramon y Cajal ( Site 1609)

Madrid, 28048, Spain

RECRUITING

HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1607)

Toledo, 45007, Spain

RECRUITING

Sahlgrenska Universitetssjukhuset ( Site 3201)

Gothenburg, Västra Götaland County, 41346, Sweden

ACTIVE NOT RECRUITING

UniversitätsSpital Zürich ( Site 3301)

Zurich, 8091, Switzerland

ACTIVE NOT RECRUITING

Kaohsiung Veteran General Hospital ( Site 3702)

Kaohsiung City, 813, Taiwan

ACTIVE NOT RECRUITING

National Cheng Kung University Hospital ( Site 3703)

Tainan, 704302, Taiwan

ACTIVE NOT RECRUITING

Papworth Hospital NHS Foundation Trust ( Site 1208)

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

ACTIVE NOT RECRUITING

Golden Jubilee National Hospital ( Site 1204)

Glasgow, Glasgow City, G81 4DY, United Kingdom

RECRUITING

Royal Free Hospital ( Site 1202)

London, London, City of, NW3 2QG, United Kingdom

RECRUITING

Royal Brompton Hospital ( Site 1206)

London, London, City of, SW3 6NP, United Kingdom

RECRUITING

Hammersmith Hospital ( Site 1203)

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

ACTIVE NOT RECRUITING

Freeman Hospital ( Site 1205)

Newcastle upon Tyne, NE7 7DN, United Kingdom

ACTIVE NOT RECRUITING

Royal Hallamshire Hospital ( Site 1207)

Sheffield, S10 2JF, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (1)

• Preston IR, Badesch D, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Humbert M, McLaughlin VV, Waxman AB, Manimaran S, Mikhailova E, Reddy M, Lau A, de Oliveira Pena J, Souza R. A long-term follow-up study of sotatercept for treatment of pulmonary arterial hypertension: interim results of SOTERIA. Eur Respir J. 2025 Jul 24;66(1):2401435. doi: 10.1183/13993003.01435-2024. Print 2025 Jul.

  PMID: 39978862 RESULT

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

ACE-011

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2025
• First Posted: October 20, 2025
• Study Start: May 12, 2021
• Primary Completion (Estimated): December 7, 2028
• Study Completion (Estimated): December 7, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

AU (4); PT (1); CO (1); ES (9); DK (2); CH (1); AR (6); IL (4); SE (1); US (18); FR (12); NL (2); CZ (2); GB (7); IT (2); NZ (1); KR (3); GR (1); BE (2); TW (2)