Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)

NCT04811092 | Terminated Phase 3 Results DMC FDA Drug

• 6 other identifiers: 7962-005A011-13MK-7962-0052023-509139-16-00U1111-1309-63122021-000199-12
• Study Type: interventional
• Target: 321
• Locations: 25 countries
• Sites: 144

Brief Summary

The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension \[PAH\] therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high-risk of disease progression.

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary; Hypertension; Sotatercept

Outcome Measures

Primary Outcomes (1)

• Median Time to Clinical Worsening

  Time to clinical worsening (TTCW) is defined as time from randomization to the first confirmed morbidity event or death. Clinical worsening events are defined as all-cause death, non-planned PAH-related hospitalization of ≥ 24 hours in duration, atrial septostomy, lung transplant, and/or deterioration in performance in 6-minute walk test from baseline combined with one of the following conditions: worsening of WHO FC from baseline, signs/symptoms of increased right heart failure, addition of a background PAH therapy or change in the background PAH therapy delivery route to parenteral. All events were adjudicated by a blinded, independent committee of clinical experts. The median TTCW is presented.

  Up to ~35 months

Secondary Outcomes (13)

• Percentage of Participants Achieving the Multicomponent Improvement Endpoint of 6-Minute Walk Distance (6MWD), N-terminal Prohormone B-type Natriuretic Peptide (NT-ProBNP) WHO FC

  Baseline and Week 24

• Percentage of Participants Who Achieved a Low Registry to Evaluate Early and Long Term PAH Disease Management (REVEAL) Lite 2 Risk Score

  Baseline and Week 24

• Percentage of Participants Who Maintain or Achieve a Low Simplified French Risk Score

  Baseline and Week 24

• Median Change From Baseline in NT-proBNP Levels at Week 24

  Baseline and Week 24

• Percentage of Participants Who Improve in WHO FC or Maintain WHO FC II at 24 Weeks From Baseline

  Baseline and Week 24

Study Arms (2)

Sotatercept plus background PAH therapy

EXPERIMENTAL

Participants received sotatercept 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.

Drug: Sotatercept

Placebo plus background therapy

PLACEBO COMPARATOR

Participants received placebo SC every 21 days plus background PAH therapy.

Other: Placebo

Interventions

Sotatercept DRUG

SC injection

Also known as: MK-7962, ACE-011

Sotatercept plus background PAH therapy

Placebo OTHER

Placebo-matched SC injection

Placebo plus background therapy

Eligibility Criteria

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

You may qualify if:

• Documented diagnostic right heart catheterization (RHC) within 12 months of screening documenting a minimum pulmonary vascular resistance (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
• Symptomatic PAH classified as World Health Organization (WHO) Functional Class (FC) II or III
• 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)
• 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
• 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)
• 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
• Male participants must meet the following criteria:

You may not qualify if:

• Diagnosis of pulmonary hypertension (PH) WHO Groups 2, 3, 4, or 5
• 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
• Hemoglobin at screening above gender-specific upper limit of normal (ULN), per local laboratory test
• 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
• Baseline systolic BP \< 90 mmHg at screening
• Pregnant or breastfeeding women
• Any of the following clinical laboratory values at the Screening Visit:
• Estimated glomerular filtration rate \< 30 mL/min/1.73 m\^2 (as defined by The Modification of Diet in Renal Disease \[MDRD\] equation)
• Serum alanine aminotransferase, aspartate aminotransferase, and total bilirubin levels \> 3 × ULN
• Platelet count \< 50,000/mm\^3 (\< 50.0 × 10\^9 /L)
• 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
• Known allergic reaction to sotatercept (ACE-011), its excipients, or luspatercept
• History of pneumonectomy
• Pulmonary function test values of forced vital capacity \< 60% predicted within 1 year prior to the Screening Visit
• Stopped receiving any PH chronic general supportive therapy (e.g., diuretics, oxygen, anticoagulants, and digoxin) within 60 days prior to the Screening Visit

Sponsors & Collaborators

• Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA: lead

Study Sites (152)

Arizona Pulmonary Specialists ( Site 1010)

Scottsdale, Arizona, 85258, United States

Location

University of Arizona ( Site 1006)

Tucson, Arizona, 85724, United States

Location

University of California San Diego ( Site 1002)

La Jolla, California, 92037, United States

Location

UCLA Medical Center ( Site 1068)

Los Angeles, California, 90095, United States

Location

University of California Irvine ( Site 1086)

Orange, California, 92868, United States

Location

Santa Barbara Pulmonary Associates ( Site 1060)

Santa Barbara, California, 93105-5316, United States

Location

University of California Davis Medical Center ( Site 1064)

Sherman Oaks, California, 95817, United States

Location

University of Colorado Hospital ( Site 1013)

Aurora, Colorado, 80045, United States

Location

AdventHealth Medical Group Advanced Lung Disease ( Site 1058)

Orlando, Florida, 32804, United States

Location

University of Iowa Hospital and Clinics ( Site 1050)

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins Hospital ( Site 1036)

Baltimore, Maryland, 21287-0005, United States

Location

Tufts Medical Center - PPDS ( Site 1014)

Boston, Massachusetts, 02111-1526, United States

Location

Boston Medical Center ( Site 1012)

Boston, Massachusetts, 02118, United States

Location

University of Michigan ( Site 1011)

Ann Arbor, Michigan, 48109, United States

Location

University of Kansas Medical Center ( Site 1020)

Kansas City, Missouri, 66160, United States

Location

Washington University School of Medicine ( Site 1022)

St Louis, Missouri, 63110, United States

Location

University of New Mexico, Health Sciences Center ( Site 1048)

Albuquerque, New Mexico, 87131, United States

Location

NYU Langone Health ( Site 1052)

New York, New York, 10016-9196, United States

Location

University of North Carolina at Chapel Hill ( Site 1042)

Chapel Hill, North Carolina, 27514, United States

Location

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

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati ( Site 1035)

Cincinnati, Ohio, 45219, United States

Location

The Cleveland Clinic Foundation Taussig Cancer Center ( Site 1065)

Cleveland, Ohio, 44195, United States

Location

Nazih Zuhdi Transplantation Institute ( Site 1084)

Oklahoma City, Oklahoma, 73112-4421, United States

Location

Oregon Health & Science University ( Site 1054)

Portland, Oregon, 97239, United States

Location

Medical University of South Carolina ( Site 1003)

Charleston, South Carolina, 29425-8900, United States

Location

Vanderbilt University Medical Center ( Site 1027)

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern Medical Center ( Site 1038)

Dallas, Texas, 78701, United States

Location

University of Utah ( Site 1049)

Salt Lake City, Utah, 84132-0001, United States

Location

Cardiologia Palermo ( Site 1911)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425BNG, Argentina

Location

Centro Medico Dra De Salvo ( Site 1904)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina

Location

Hospital Universitario Austral ( Site 1901)

Pilar, Buenos Aires, B1629ODT, Argentina

Location

Instituto de Investigaciones Clinicas Quilmes ( Site 1903)

Quilmes, Buenos Aires, 1878, Argentina

Location

Instituto De Enfermedades Respiratorias E Investigacion Medica ( Site 1910)

Villa Vatteone, Buenos Aires, B1853AIK, Argentina

Location

Instituto Médico DAMIC ( Site 1909)

Córdoba, Córdoba Province, 5003DCE, Argentina

Location

Instituto Medico Rio Cuarto ( Site 1907)

Río Cuarto, Córdoba Province, X5800AEV, Argentina

Location

Hospital Provincial del Centenario ( Site 1912)

Rosario, Santa Fe Province, 2002, Argentina

Location

Instituto Cardiovascular de Rosario ( Site 1906)

Rosario, Santa Fe Province, S2000DSR, Argentina

Location

Sanatorio Parque ( Site 1905)

Rosario, Santa Fe Province, S2000DSV, Argentina

Location

Sanatorio Allende ( Site 1908)

Córdoba, X5021FPQ, Argentina

Location

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

Santa Fe, S3000EOZ, Argentina

Location

Royal Prince Alfred Hospital ( Site 1106)

Camperdown, New South Wales, 2050, Australia

Location

John Hunter Hospital ( Site 1101)

Newcastle, New South Wales, 2308, Australia

Location

Prince Charles Hospital ( Site 1104)

Chermside, Queensland, 4032, Australia

Location

Princess Alexandra Hospital ( Site 1108)

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital ( Site 1109)

Adelaide, South Australia, 5000, Australia

Location

Royal Hobart Hospital ( Site 1107)

Hobart, Tasmania, 7000, Australia

Location

Fiona Stanley Hospital ( Site 1103)

Murdoch, Western Australia, 6150, Australia

Location

Medizinische Universitat Wien ( Site 2001)

Vienna, State of Vienna, 1090, Austria

Location

Medizinische Universität Graz ( Site 2003)

Graz, Styria, 8036, Austria

Location

Medizinische Universitat Innsbruck ( Site 2004)

Innsbruck, Tyrol, 6020, Austria

Location

Ordensklinikum Linz GmbH Elisabethinen ( Site 2002)

Linz, Upper Austria, 4020, Austria

Location

Hopital Erasme ( Site 1402)

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

Location

UZ Gasthuisberg ( Site 1401)

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Hospital Madre Teresa ( Site 1804)

Belo Horizonte, Minas Gerais, 30430-142, Brazil

Location

Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805)

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital Sao Paulo ( Site 1806)

São Paulo, São Paulo, 04038-031, Brazil

Location

Instituto do Coracao - HCFMUSP ( Site 1803)

São Paulo, 05403-000, Brazil

Location

University of Alberta Hospital ( Site 2101)

Edmonton, Alberta, T6G 2B7, Canada

Location

St Boniface General Hospital ( Site 2106)

Winnepeg, Manitoba, R2H 2A6, Canada

Location

McMaster University - HSC ( Site 2105)

Hamilton, Ontario, L8N 4A6, Canada

Location

Sir Mortimer B Davis Jewish General Hospital ( Site 2103)

Montreal, Quebec, H3T 1E2, Canada

Location

Centro Cardiovascular Colombiano Clínica Santa María Clínica Cardio VID ( Site 3402)

Medellín, Antioquia, 50034, Colombia

Location

Fundacion Neumologica Colombiana ( Site 3403)

Bogota, Cundinamarca, 110131, Colombia

Location

Fundacion Valle Del Lili ( Site 3401)

Cali, Valle del Cauca Department, 760032, Colombia

Location

Centro Medico Imbanaco de Cali S.A ( Site 3404)

Cali, Valle del Cauca Department, 760042, Colombia

Location

University Hospital Centre Split city ( Site 3901)

Split, Split-Dalmatia County, 21000, Croatia

Location

Klinicki Bolnicki Centar Zagreb ( Site 3902)

Zagreb, Zagreb County, 10000, Croatia

Location

Institut Klinicke a Experimentalni Mediciny ( Site 2202)

Prague, Praha 4, 140 21, Czechia

Location

Vseobecna fakultni nemocnice v Praze ( Site 2201)

Prague, 128 08, Czechia

Location

Rigshospitalet ( Site 3802)

København Ø, Capital Region, 2100, Denmark

Location

Aarhus Universitetshospital, Skejby ( Site 3801)

Aarhus, Central Jutland, 8200, Denmark

Location

Hopital Louis Pasteur ( Site 1311)

Nice, Alpes-Maritimes, 06001, France

Location

Hopital Louis Pradel ( Site 1317)

Lyon, Auvergne, 69003, France

Location

Hopitaux Universitaires de Strasbourg ( Site 1307)

Strasbourg, Bas-Rhin, 67000, France

Location

Hopital Cavale Blanche ( Site 1314)

Brest, Brittany Region, 29200, France

Location

CHU Caen Normandie ( Site 1325)

Caen, Calvados, 14033, France

Location

CHU de Besancon ( Site 1303)

Besançon, Doubs, 25000, France

Location

Hopital Haut Leveque ( Site 1312)

Bordeaux, Gironde, 33604, France

Location

CHU de Toulouse - Hopital Larrey ( Site 1315)

Toulouse, Haute-Garonne, 31059, France

Location

C.H.U. de Tours - Hopital Bretonneau ( Site 1310)

Tours, Indre-et-Loire, 37000, France

Location

Hopital Nord Laennec ( Site 1309)

Nantes, Loire-Atlantique, 44000, France

Location

CHU Angers ( Site 1313)

Angers, Maine-et-Loire, 49933, France

Location

C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France

Location

Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)

Saint-Priest-en-Jarez, Pays de la Loire Region, 42270, France

Location

CHU - Hopital de Bicetre ( Site 1304)

Le Kremlin-Bicêtre, Val-de-Marne, 94270, France

Location

CHU de Poitiers ( Site 1316)

Poitiers, Vienne, 86000, France

Location

Universitaetsklinikum Heidelberg ( Site 1509)

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Krankenhaus Neuwittelsbach ( Site 1510)

Munich, Bavaria, 80639, Germany

Location

Universitaetsklinik Regensburg ( Site 1503)

Regensburg, Bavaria, 93053, Germany

Location

Medizinische Hochschule Hannover ( Site 1505)

Hanover, Lower Saxony, 30625, Germany

Location

Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)

Bad Oeynhausen, North Rhine-Westphalia, 35392, Germany

Location

Uniklinik Köln ( Site 1511)

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitatsklinikum des Saarlandes ( Site 1513)

Homburg, Saarland, 66421, Germany

Location

Universitaetsklinikum Carl Gustav Carus ( Site 1501)

Dresden, Saxony, 01307, Germany

Location

Universitatsklinikum Leipzig ( Site 1508)

Leipzig, Saxony, 04103, Germany

Location

Universitaetsklinik und Poliklinik Halle/Saale ( Site 1502)

Halle, Saxony-Anhalt, 06120, Germany

Location

DRK Kliniken Berlin Westend ( Site 1507)

Berlin, 14050, Germany

Location

Evangelismos General Hospital of Athens ( Site 3605)

Athens, Attica, 106 76, Greece

Location

Onassis Cardiac Surgery Center ( Site 3602)

Athens, Attica, 176 74, Greece

Location

Attikon University General Hospital of Athens ( Site 3604)

Haidari, Attica, 124 62, Greece

Location

AHEPA University General Hospital of Thessaloniki ( Site 3601)

Thessaloniki, 546 36, Greece

Location

Assuta Ashdod Medical Center ( Site 1710)

Ashdod, 7747629, Israel

Location

Lady Davis Carmel Medical Center ( Site 1705)

Haifa, 3436212, Israel

Location

Hadassah Medical Center ( Site 1711)

Jerusalem, 9112001, Israel

Location

Sheba Medical Center ( Site 1701)

Tel Litwinsky, 52621, Israel

Location

Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)

Trieste, Friuli Venezia Giulia, 34149, Italy

Location

Ospedale S. Giuseppe Multimedica ( Site 2403)

Milan, Lombardy, 20123, Italy

Location

Azienda Ospedaliera San Gerardo di Monza ( Site 2406)

Monza, Monza E Brianza, 20900, Italy

Location

Azienda Ospedaliera R. N. V. Monaldi ( Site 2407)

Naples, 80131, Italy

Location

La Sapienza-Università di Roma-Policlinico Umberto I ( Site 2402)

Roma, 161, Italy

Location

Radboud University Nijmegen Medical Centre ( Site 2605)

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Maastricht University Medical Center ( Site 2603)

Maastricht, Limburg, 6229 HX, Netherlands

Location

VU Medisch Centrum ( Site 2601)

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Erasmus MC ( Site 2604)

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Waikato District Health Board ( Site 2702)

Hamilton, Waikato Region, 3204, New Zealand

Location

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

Krakow, Lesser Poland Voivodeship, 31-202, Poland

Location

Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 2802)

Warsaw, Masovian Voivodeship, 01-138, Poland

Location

Hospital Garcia de Orta ( Site 3501)

Almada, Setúbal District, 2801-951, Portugal

Location

Centro Hospitalar E Universitário De Coimbra ( Site 3502)

Coimbra, 3000-075, Portugal

Location

Hospital Pulido Valente ( Site 3503)

Lisbon, 1769-001, Portugal

Location

Institute for pulmonary diseases of Vojvodina ( Site 2906)

Kamenitz, Juznobacki Okrug, 21204, Serbia

Location

University Clinical Center Nis ( Site 2904)

Niš, Nisavski Okrug, 18000, Serbia

Location

Clinical Center Kragujevac ( Site 2905)

Kragujevac, Sumadijski Okrug, 34000, Serbia

Location

Clinical Center of Serbia ( Site 2901)

Belgrade, 11000, Serbia

Location

Gachon University Gil Medical Center ( Site 3103)

Namdong-Gu, Incheon, 21565, South Korea

Location

Chonnam National University Hospital ( Site 3105)

Gwangju, Kyonggi-do, 61469, South Korea

Location

Samsung Medical Center ( Site 3106)

Seuol, Seoul, 06351, South Korea

Location

Seoul National University Hospital ( Site 3102)

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System - PPDS ( Site 3101)

Seoul, 03722, South Korea

Location

The Catholic University of Korea St. Mary s Hospital ( Site 3104)

Seoul, 06591, South Korea

Location

Hospital Universitario de Son Espases ( Site 1611)

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Hospital Universitario Marques de Valdecilla ( Site 1601)

Santander, Cantabria, 39008, Spain

Location

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

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitari Vall de Hebron ( Site 1605)

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre ( Site 1603)

Madrid, 28041, Spain

Location

Hospital Universitario La Paz ( Site 1610)

Madrid, 28046, Spain

Location

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608)

Salamanca, 37007, Spain

Location

Hospital Virgen de la Salud ( Site 1607)

Toledo, 45004, Spain

Location

Skanes Universitetssjukhus Lund ( Site 3203)

Lund, Skåne County, 22185, Sweden

Location

Hjart-lungmedicin och klinisk fysiologi ( Site 3204)

Uppsala, Uppsala County, 751 85, Sweden

Location

Norrlands Universitetssjukhus ( Site 3205)

Umeå, Västerbotten County, 90185, Sweden

Location

UniversitätsSpital Zürich ( Site 3301)

Zurich, 8091, Switzerland

Location

Kaohsiung Veterans General Hospital ( Site 3702)

Kaohsiung City, 81362, Taiwan

Location

China Medical University Hospital ( Site 3701)

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital ( Site 3703)

Tainan, 704, Taiwan

Location

Papworth Hospital NHS Foundation Trust ( Site 1208)

Cambrigge, Cambridgeshire, CB23 0AY, United Kingdom

Location

Sheffield Teaching Hospital NHS Foundation Trust ( Site 1207)

Sheffield, Derbyshire, S10 2JF, United Kingdom

Location

Golden Jubilee National Hospital ( Site 1204)

Glasgow, Glasgow City, G81 4DY, United Kingdom

Location

Royal Free London NHS Foundation Trust ( Site 1202)

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

Location

Royal Brompton Hospital ( Site 1206)

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

Location

Imperial College Healthcare NHS Trust ( Site 1203)

London, London, City of, W12 OHS, United Kingdom

Location

Freeman Hospital ( Site 1205)

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 41025556 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension

Interventions

ACE-011

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Study was stopped early due to loss of clinical equipoise based on robust evidence of clinical benefit of sotatercept demonstrated in previous studies.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 23, 2021
• Study Start: March 18, 2022
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2025
• Last Updated: April 27, 2026
• Results First Posted: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

BE (2); CA (4); US (28); IT (5); NL (4); KR (6); TW (3); CR (2); DE (11); GR (4); SE (3); PL (2); CH (1); ES (8); CO (4); GB (7); AR (12); DK (2); BR (4); CZ (2); FR (15); IL (4); NZ (1); PT (3); AU (7)