Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)
NCT ID: NCT04811092
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
321 participants
INTERVENTIONAL
2022-03-18
2025-04-03
Brief Summary
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Detailed Description
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Participants enrolled in the study will have a diagnosis within 12 months of study screening of symptomatic PAH (World Health Organization (WHO) Group 1, classified as functional class (FC) II or III) and presentation of idiopathic or heritable PAH, PAH associated with connective tissue diseases (CTD), drug- or toxin- induced PAH, post shunt correction PAH, or PAH presenting at least 1 year following the correction of congenital heart defects.
As of Amendment 11, this study will be closed so that all eligible participants can receive sotatercept either on the MK-7962-004 extension study (SOTERIA, NCT04796337,) or by commercial access, if available. All eligible participants will complete the end of treatment visit before enrollment in the extension study or initiation of commercial product. Participants not enrolling into the extension study or initiating commercial product will complete the end of study visit.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo plus background PAH therapy
Administered subcutaneously (SC) every 21 days plus background PAH therapy
Placebo
Placebo
Sotatercept plus background PAH therapy
Administered at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, subcutaneously (SC) every 21 days plus background PAH therapy
Sotatercept
Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1
Interventions
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Sotatercept
Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Age ≥ 18 years
2. Documented diagnostic right heart catheterization (RHC) within 12 months of screening documenting a minimum PVR of ≥ 4 Wood units and pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of ≤ 15 mmHg, with the diagnosis of WHO PAH Group 1 in any of the following subtypes:
* Idiopathic PAH
* Heritable PAH
* Drug/toxin-induced PAH
* PAH associated with connective tissue disease
* PAH associated with simple, congenital systemic to pulmonary shunts at least 1 year following repair
3. Symptomatic PAH classified as WHO FC II or III
4. Either Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) Lite 2 Risk Score ≥ 6 or Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA) 2.0 risk score ≥2 (intermediate to-low-risk or above)
5. Diagnosis of PAH within 12 months of screening and on stable doses of a double or triple combination of background PAH therapies and diuretics (if any) for at least 90 days prior to screening
6. Six-minute walk distance ≥ 150 m repeated twice at screening at least 4 hours apart, but no longer than 1 week apart, and both values are within 15% of each other (calculated from the highest value)
7. Females of childbearing potential must meet the following criteria:
* Have 2 negative urine or serum pregnancy tests as verified by the investigator prior to starting study drug administration; she must agree to ongoing urine or serum pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug
* If sexually active with a male partner, have used highly effective contraception without interruption, for at least 28 days prior to starting the investigational product AND agreed to use the same highly effective contraception in combination with a barrier method during the study (including dose interruptions) and for 16 weeks (112 days) after discontinuation of study treatment
* Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study treatment
8. Male participants must meet the following criteria:
* Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy
* Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study treatment
9. Ability to adhere to study visit schedule and understand and comply with all protocol requirements
10. Ability to understand and provide written informed consent
Exclusion Criteria
1. Diagnosis of pulmonary hypertension (PH) WHO Groups 2, 3, 4, or 5
2. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH, pulmonary veno occlusive disease, and pulmonary capillary hemangiomatosis
3. Hemoglobin at screening above gender-specific upper limit of normal (ULN), per local laboratory test
4. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) \> 180 mmHg or sitting diastolic BP \> 110 mmHg during the Screening Visit after a period of rest
5. Baseline systolic BP \< 90 mmHg at screening
6. Pregnant or breastfeeding women
7. Any of the following clinical laboratory values at the Screening Visit:
* Estimated glomerular filtration rate \< 30 mL/min/1.73 m2 (as defined by MDRD equation)
* Serum alanine aminotransferase, aspartate aminotransferase, and total bilirubin levels \> 3 × ULN
* Platelet count \< 50,000/mm3 (\< 50.0 × 109 /L)
8. Currently enrolled in or have completed any other investigational product study within 30 days for small molecule drugs or within 5 half-lives for investigational biologics prior to the date of documented informed consent
9. Known allergic reaction to sotatercept (ACE-011), its excipients, or luspatercept
10. History of pneumonectomy
11. Pulmonary function test values of forced vital capacity \< 60% predicted within 1 year prior to the Screening Visit
12. Stopped receiving any PH chronic general supportive therapy (e.g., diuretics, oxygen, anticoagulants, and digoxin) within 60 days prior to the Screening Visit
13. Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to the Screening Visit or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible)
14. Untreated more than mild obstructive sleep apnea
15. History of known pericardial constriction
16. History of restrictive or congestive cardiomyopathy
17. History of atrial septostomy within 180 days prior to the Screening Visit
18. Electrocardiogram with Fridericia's corrected QT interval \> 500 ms during the Screening Period
19. Personal or family history of long QT syndrome or sudden cardiac death
20. Left ventricular ejection fraction \< 50% on historical echocardiogram (ECHO) within 1 year prior to the Screening Visit
21. Any current or prior history of symptomatic coronary disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) in the past 6 months prior to the Screening Visit
22. Cerebrovascular accident within 3 months prior to the Screening Visit
23. Acutely decompensated heart failure within 30 days prior to the Screening Visit, as per investigator assessment
24. Significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
25. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, and vasopressin) within 30 days prior to the Screening Visit
26. Has an active malignancy with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in-situ, or prostate cancer that is not currently or expected, during the study, to be treated with radiation therapy, chemotherapy, and/or surgical intervention, or hormonal treatment
18 Years
ALL
No
Sponsors
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Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Arizona Pulmonary Specialists ( Site 1010)
Scottsdale, Arizona, United States
University of Arizona ( Site 1006)
Tucson, Arizona, United States
University of California San Diego ( Site 1002)
La Jolla, California, United States
UCLA Medical Center ( Site 1068)
Los Angeles, California, United States
University of California Irvine ( Site 1086)
Orange, California, United States
Santa Barbara Pulmonary Associates ( Site 1060)
Santa Barbara, California, United States
University of California Davis Medical Center ( Site 1064)
Sherman Oaks, California, United States
University of Colorado Hospital ( Site 1013)
Aurora, Colorado, United States
AdventHealth Medical Group Advanced Lung Disease ( Site 1058)
Orlando, Florida, United States
University of Iowa Hospital and Clinics ( Site 1050)
Iowa City, Iowa, United States
Johns Hopkins Hospital ( Site 1036)
Baltimore, Maryland, United States
Tufts Medical Center - PPDS ( Site 1014)
Boston, Massachusetts, United States
Boston Medical Center ( Site 1012)
Boston, Massachusetts, United States
University of Michigan ( Site 1011)
Ann Arbor, Michigan, United States
University of Kansas Medical Center ( Site 1020)
Kansas City, Missouri, United States
Washington University School of Medicine ( Site 1022)
St Louis, Missouri, United States
University of New Mexico, Health Sciences Center ( Site 1048)
Albuquerque, New Mexico, United States
NYU Langone Health ( Site 1052)
New York, New York, United States
University of North Carolina at Chapel Hill ( Site 1042)
Chapel Hill, North Carolina, United States
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
Cincinnati, Ohio, United States
University of Cincinnati ( Site 1035)
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation Taussig Cancer Center ( Site 1065)
Cleveland, Ohio, United States
Nazih Zuhdi Transplantation Institute ( Site 1084)
Oklahoma City, Oklahoma, United States
Oregon Health & Science University ( Site 1054)
Portland, Oregon, United States
Medical University of South Carolina ( Site 1003)
Charleston, South Carolina, United States
Vanderbilt University Medical Center ( Site 1027)
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center ( Site 1038)
Dallas, Texas, United States
University of Utah ( Site 1049)
Salt Lake City, Utah, United States
Cardiologia Palermo ( Site 1911)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Centro Medico Dra De Salvo ( Site 1904)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital Universitario Austral ( Site 1901)
Pilar, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
Quilmes, Buenos Aires, Argentina
Instituto De Enfermedades Respiratorias E Investigacion Medica ( Site 1910)
Villa Vatteone, Buenos Aires, Argentina
Instituto Médico DAMIC ( Site 1909)
Córdoba, Córdoba Province, Argentina
Instituto Medico Rio Cuarto ( Site 1907)
Río Cuarto, Córdoba Province, Argentina
Hospital Provincial del Centenario ( Site 1912)
Rosario, Santa Fe Province, Argentina
Instituto Cardiovascular de Rosario ( Site 1906)
Rosario, Santa Fe Province, Argentina
Sanatorio Parque ( Site 1905)
Rosario, Santa Fe Province, Argentina
Sanatorio Allende ( Site 1908)
Córdoba, , Argentina
Hospital Provincial Dr. Jose M. Cullen ( Site 1902)
Santa Fe, , Argentina
Royal Prince Alfred Hospital ( Site 1106)
Camperdown, New South Wales, Australia
John Hunter Hospital ( Site 1101)
Newcastle, New South Wales, Australia
Prince Charles Hospital ( Site 1104)
Chermside, Queensland, Australia
Princess Alexandra Hospital ( Site 1108)
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital ( Site 1109)
Adelaide, South Australia, Australia
Royal Hobart Hospital ( Site 1107)
Hobart, Tasmania, Australia
Fiona Stanley Hospital ( Site 1103)
Murdoch, Western Australia, Australia
Medizinische Universität Graz ( Site 2003)
Graz, Styria, Austria
Medizinische Universitat Innsbruck ( Site 2004)
Innsbruck, Tyrol, Austria
Ordensklinikum Linz GmbH Elisabethinen ( Site 2002)
Linz, Upper Austria, Austria
Medizinische Universitat Wien ( Site 2001)
Vienna, Vienna, Austria
Hopital Erasme ( Site 1402)
Anderlecht, Bruxelles-Capitale, Region de, Belgium
UZ Gasthuisberg ( Site 1401)
Leuven, Vlaams-Brabant, Belgium
Hospital Madre Teresa ( Site 1804)
Belo Horizonte, Minas Gerais, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Paulo ( Site 1806)
São Paulo, São Paulo, Brazil
Instituto do Coracao - HCFMUSP ( Site 1803)
São Paulo, , Brazil
University of Alberta Hospital ( Site 2101)
Edmonton, Alberta, Canada
St Boniface General Hospital ( Site 2106)
Winnepeg, Manitoba, Canada
McMaster University - HSC ( Site 2105)
Hamilton, Ontario, Canada
Sir Mortimer B Davis Jewish General Hospital ( Site 2103)
Montreal, Quebec, Canada
Centro Cardiovascular Colombiano Clínica Santa María Clínica Cardio VID ( Site 3402)
Medellín, Antioquia, Colombia
Fundacion Neumologica Colombiana ( Site 3403)
Bogota, Cundinamarca, Colombia
Fundacion Valle Del Lili ( Site 3401)
Cali, Valle del Cauca Department, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 3404)
Cali, Valle del Cauca Department, Colombia
University Hospital Centre Split city ( Site 3901)
Split, Split-Dalmatia County, Croatia
Klinicki Bolnicki Centar Zagreb ( Site 3902)
Zagreb, Zagreb County, Croatia
Institut Klinicke a Experimentalni Mediciny ( Site 2202)
Prague, Praha 4, Czechia
Vseobecna fakultni nemocnice v Praze ( Site 2201)
Prague, , Czechia
Rigshospitalet ( Site 3802)
København Ø, Capital Region, Denmark
Aarhus Universitetshospital, Skejby ( Site 3801)
Aarhus, Central Jutland, Denmark
Hopital Louis Pasteur ( Site 1311)
Nice, Alpes-Maritimes, France
Hopital Louis Pradel ( Site 1317)
Lyon, Auvergne, France
Hopitaux Universitaires de Strasbourg ( Site 1307)
Strasbourg, Bas-Rhin, France
Hopital Cavale Blanche ( Site 1314)
Brest, Brittany Region, France
CHU Caen Normandie ( Site 1325)
Caen, Calvados, France
CHU de Besancon ( Site 1303)
Besançon, Doubs, France
Hopital Haut Leveque ( Site 1312)
Bordeaux, Gironde, France
CHU de Toulouse - Hopital Larrey ( Site 1315)
Toulouse, Haute-Garonne, France
C.H.U. de Tours - Hopital Bretonneau ( Site 1310)
Tours, Indre-et-Loire, France
Hopital Nord Laennec ( Site 1309)
Nantes, Loire-Atlantique, France
CHU Angers ( Site 1313)
Angers, Maine-et-Loire, France
C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)
Saint-Priest-en-Jarez, Pays de la Loire Region, France
CHU - Hopital de Bicetre ( Site 1304)
Le Kremlin-Bicêtre, Val-de-Marne, France
CHU de Poitiers ( Site 1316)
Poitiers, Vienne, France
Universitaetsklinikum Heidelberg ( Site 1509)
Heidelberg, Baden-Wurttemberg, Germany
Krankenhaus Neuwittelsbach ( Site 1510)
Munich, Bavaria, Germany
Universitaetsklinik Regensburg ( Site 1503)
Regensburg, Bavaria, Germany
Medizinische Hochschule Hannover ( Site 1505)
Hanover, Lower Saxony, Germany
Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)
Bad Oeynhausen, North Rhine-Westphalia, Germany
Uniklinik Köln ( Site 1511)
Cologne, North Rhine-Westphalia, Germany
Universitatsklinikum des Saarlandes ( Site 1513)
Homburg, Saarland, Germany
Universitaetsklinikum Carl Gustav Carus ( Site 1501)
Dresden, Saxony, Germany
Universitatsklinikum Leipzig ( Site 1508)
Leipzig, Saxony, Germany
Universitaetsklinik und Poliklinik Halle/Saale ( Site 1502)
Halle, Saxony-Anhalt, Germany
DRK Kliniken Berlin Westend ( Site 1507)
Berlin, , Germany
Evangelismos General Hospital of Athens ( Site 3605)
Athens, Attica, Greece
Onassis Cardiac Surgery Center ( Site 3602)
Athens, Attica, Greece
Attikon University General Hospital of Athens ( Site 3604)
Haidari, Attica, Greece
AHEPA University General Hospital of Thessaloniki ( Site 3601)
Thessaloniki, , Greece
Assuta Ashdod Medical Center ( Site 1710)
Ashdod, , Israel
Lady Davis Carmel Medical Center ( Site 1705)
Haifa, , Israel
Hadassah Medical Center ( Site 1711)
Jerusalem, , Israel
Sheba Medical Center ( Site 1701)
Tel Litwinsky, , Israel
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)
Trieste, Friuli Venezia Giulia, Italy
Ospedale S. Giuseppe Multimedica ( Site 2403)
Milan, Lombardy, Italy
Azienda Ospedaliera San Gerardo di Monza ( Site 2406)
Monza, Monza E Brianza, Italy
Azienda Ospedaliera R. N. V. Monaldi ( Site 2407)
Napoli, , Italy
La Sapienza-Università di Roma-Policlinico Umberto I ( Site 2402)
Roma, , Italy
Radboud University Nijmegen Medical Centre ( Site 2605)
Nijmegen, Gelderland, Netherlands
Maastricht University Medical Center ( Site 2603)
Maastricht, Limburg, Netherlands
VU Medisch Centrum ( Site 2601)
Amsterdam, North Holland, Netherlands
Erasmus MC ( Site 2604)
Rotterdam, South Holland, Netherlands
Waikato District Health Board ( Site 2702)
Hamilton, Waikato Region, New Zealand
Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)
Krakow, Lesser Poland Voivodeship, Poland
Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 2802)
Warsaw, Masovian Voivodeship, Poland
Hospital Garcia de Orta ( Site 3501)
Almada, Setúbal District, Portugal
Centro Hospitalar E Universitário De Coimbra ( Site 3502)
Coimbra, , Portugal
Hospital Pulido Valente ( Site 3503)
Lisbon, , Portugal
Clinical Center of Serbia ( Site 2901)
Belgrade, Beograd, Serbia
Institute for pulmonary diseases of Vojvodina ( Site 2906)
Kamenitz, Juznobacki Okrug, Serbia
University Clinical Center Nis ( Site 2904)
Niš, Nisavski Okrug, Serbia
Clinical Center Kragujevac ( Site 2905)
Kragujevac, Sumadijski Okrug, Serbia
Gachon University Gil Medical Center ( Site 3103)
Namdong-Gu, Incheon, South Korea
Chonnam National University Hospital ( Site 3105)
Gwangju, Kyonggi-do, South Korea
Samsung Medical Center ( Site 3106)
Seuol, Seoul, South Korea
Seoul National University Hospital ( Site 3102)
Seoul, , South Korea
Severance Hospital Yonsei University Health System - PPDS ( Site 3101)
Seoul, , South Korea
The Catholic University of Korea St. Mary s Hospital ( Site 3104)
Seoul, , South Korea
Hospital Universitario de Son Espases ( Site 1611)
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario Marques de Valdecilla ( Site 1601)
Santander, Cantabria, Spain
Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604)
Majadahonda, Madrid, Spain
Hospital Universitari Vall de Hebron ( Site 1605)
Barcelona, , Spain
Hospital Universitario 12 de Octubre ( Site 1603)
Madrid, , Spain
Hospital Universitario La Paz ( Site 1610)
Madrid, , Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608)
Salamanca, , Spain
Hospital Virgen de la Salud ( Site 1607)
Toledo, , Spain
Skanes Universitetssjukhus Lund ( Site 3203)
Lund, Skåne County, Sweden
Hjart-lungmedicin och klinisk fysiologi ( Site 3204)
Uppsala, Uppsala County, Sweden
Norrlands Universitetssjukhus ( Site 3205)
Umeå, Västerbotten County, Sweden
UniversitätsSpital Zürich ( Site 3301)
Zurich, , Switzerland
Kaohsiung Veterans General Hospital ( Site 3702)
Kaohsiung City, , Taiwan
China Medical University Hospital ( Site 3701)
Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 3703)
Tainan City, , Taiwan
Papworth Hospital NHS Foundation Trust ( Site 1208)
Cambrigge, Cambridgeshire, United Kingdom
Sheffield Teaching Hospital NHS Foundation Trust ( Site 1207)
Sheffield, Derbyshire, United Kingdom
Golden Jubilee National Hospital ( Site 1204)
Glasgow, Glasgow City, United Kingdom
Royal Free London NHS Foundation Trust ( Site 1202)
London, London, City of, United Kingdom
Royal Brompton Hospital ( Site 1206)
London, London, City of, United Kingdom
Imperial College Healthcare NHS Trust ( Site 1203)
London, London, City of, United Kingdom
Freeman Hospital ( Site 1205)
Newcastle upon Tyne, , United Kingdom
Countries
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References
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McLaughlin VV, Hoeper MM, Badesch DB, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, Preston IR, Souza R, Waxman AB, Kopec G, Meyer G, Olsson KM, Fu W, Shi Y, Miller B, Kim SS, Mackenzie HS, Brambatti M, Patel MJ, Koglin J, Cornell AG, Humbert M; HYPERION Trial Investigators. Sotatercept for Pulmonary Arterial Hypertension within the First Year after Diagnosis. N Engl J Med. 2025 Oct 23;393(16):1599-1611. doi: 10.1056/NEJMoa2508170. Epub 2025 Sep 30.
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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A011-13
Identifier Type: OTHER
Identifier Source: secondary_id
MK-7962-005
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509139-16
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1309-6312
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-000199-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7962-005
Identifier Type: -
Identifier Source: org_study_id
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