AzTrials
AzTrials

Pulmonary Arterial HypertensionPhase 3HYPERIONNCT04811092

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

A Phase 3 study testing Sotatercept in people with Pulmonary Arterial Hypertension, run by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA at 152 sites in 27 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Sotatercept
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
321 participants
Where
152 sitesin 27 countries
Study dates
18 Mar 2022to 3 Apr 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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:
  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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
  • 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)
  • Untreated more than mild obstructive sleep apnea
  • History of known pericardial constriction
  • History of restrictive or congestive cardiomyopathy
  • History of atrial septostomy within 180 days prior to the Screening Visit
  • Electrocardiogram with Fridericia's corrected QT interval > 500 ms during the Screening Period
  • Personal or family history of long QT syndrome or sudden cardiac death
  • Left ventricular ejection fraction < 50% on historical echocardiogram (ECHO) within 1 year prior to the Screening Visit
  • 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
  • Cerebrovascular accident within 3 months prior to the Screening Visit
  • Acutely decompensated heart failure within 30 days prior to the Screening Visit, as per investigator assessment
  • Significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
  • Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, and vasopressin) within 30 days prior to the Screening Visit
  • 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

Trial locations and contacts

152 sites in 27 countries.

152 sites in 27 countries

United States28 sites

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

    Albuquerque, New Mexico, 87131

  • University of Michigan ( Site 1011)

    Ann Arbor, Michigan, 48109

  • University of Colorado Hospital ( Site 1013)

    Aurora, Colorado, 80045

  • Johns Hopkins Hospital ( Site 1036)

    Baltimore, Maryland, 21287-0005

  • Tufts Medical Center - PPDS ( Site 1014)

    Boston, Massachusetts, 02111-1526

  • Boston Medical Center ( Site 1012)

    Boston, Massachusetts, 02118

  • University of North Carolina at Chapel Hill ( Site 1042)

    Chapel Hill, North Carolina, 27514

  • Medical University of South Carolina ( Site 1003)

    Charleston, South Carolina, 29425-8900

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

    Cincinnati, Ohio, 45219

  • University of Cincinnati ( Site 1035)

    Cincinnati, Ohio, 45219

  • The Cleveland Clinic Foundation Taussig Cancer Center ( Site 1065)

    Cleveland, Ohio, 44195

  • University of Texas Southwestern Medical Center ( Site 1038)

    Dallas, Texas, 78701

  • University of Iowa Hospital and Clinics ( Site 1050)

    Iowa City, Iowa, 52242

  • University of Kansas Medical Center ( Site 1020)

    Kansas City, Missouri, 66160

  • University of California San Diego ( Site 1002)

    La Jolla, California, 92037

  • UCLA Medical Center ( Site 1068)

    Los Angeles, California, 90095

  • Vanderbilt University Medical Center ( Site 1027)

    Nashville, Tennessee, 37232

  • NYU Langone Health ( Site 1052)

    New York, New York, 10016-9196

  • Nazih Zuhdi Transplantation Institute ( Site 1084)

    Oklahoma City, Oklahoma, 73112-4421

  • University of California Irvine ( Site 1086)

    Orange, California, 92868

  • AdventHealth Medical Group Advanced Lung Disease ( Site 1058)

    Orlando, Florida, 32804

  • Oregon Health & Science University ( Site 1054)

    Portland, Oregon, 97239

  • University of Utah ( Site 1049)

    Salt Lake City, Utah, 84132-0001

  • Santa Barbara Pulmonary Associates ( Site 1060)

    Santa Barbara, California, 93105-5316

  • Arizona Pulmonary Specialists ( Site 1010)

    Scottsdale, Arizona, 85258

  • University of California Davis Medical Center ( Site 1064)

    Sherman Oaks, California, 95817

  • Washington University School of Medicine ( Site 1022)

    St Louis, Missouri, 63110

  • University of Arizona ( Site 1006)

    Tucson, Arizona, 85724

Other trials in United States

France15 sites

  • CHU Angers ( Site 1313)

    Angers, Maine-et-Loire, 49933

  • CHU de Besancon ( Site 1303)

    Besançon, Doubs, 25000

  • Hopital Haut Leveque ( Site 1312)

    Bordeaux, Gironde, 33604

  • Hopital Cavale Blanche ( Site 1314)

    Brest, Brittany Region, 29200

  • CHU Caen Normandie ( Site 1325)

    Caen, Calvados, 14033

  • CHU - Hopital de Bicetre ( Site 1304)

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

  • Hopital Louis Pradel ( Site 1317)

    Lyon, Auvergne, 69003

  • Hopital Nord Laennec ( Site 1309)

    Nantes, Loire-Atlantique, 44000

  • Hopital Louis Pasteur ( Site 1311)

    Nice, Alpes-Maritimes, 06001

  • CHU de Poitiers ( Site 1316)

    Poitiers, Vienne, 86000

  • Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)

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

  • Hopitaux Universitaires de Strasbourg ( Site 1307)

    Strasbourg, Bas-Rhin, 67000

  • CHU de Toulouse - Hopital Larrey ( Site 1315)

    Toulouse, Haute-Garonne, 31059

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

    Tours, Indre-et-Loire, 37000

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

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

Other trials in France

Argentina12 sites

  • Cardiologia Palermo ( Site 1911)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425BNG

  • Centro Medico Dra De Salvo ( Site 1904)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ABP

  • Instituto Médico DAMIC ( Site 1909)

    Córdoba, Córdoba Province, 5003DCE

  • Sanatorio Allende ( Site 1908)

    Córdoba, X5021FPQ

  • Hospital Universitario Austral ( Site 1901)

    Pilar, Buenos Aires, B1629ODT

  • Instituto de Investigaciones Clinicas Quilmes ( Site 1903)

    Quilmes, Buenos Aires, 1878

  • Instituto Medico Rio Cuarto ( Site 1907)

    Río Cuarto, Córdoba Province, X5800AEV

  • Hospital Provincial del Centenario ( Site 1912)

    Rosario, Santa Fe Province, 2002

  • Instituto Cardiovascular de Rosario ( Site 1906)

    Rosario, Santa Fe Province, S2000DSR

  • Sanatorio Parque ( Site 1905)

    Rosario, Santa Fe Province, S2000DSV

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

    Santa Fe, S3000EOZ

  • Instituto De Enfermedades Respiratorias E Investigacion Medica ( Site 1910)

    Villa Vatteone, Buenos Aires, B1853AIK

Other trials in Argentina

Germany11 sites

  • Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)

    Bad Oeynhausen, North Rhine-Westphalia, 35392

  • DRK Kliniken Berlin Westend ( Site 1507)

    Berlin, 14050

  • Uniklinik Köln ( Site 1511)

    Cologne, North Rhine-Westphalia, 50937

  • Universitaetsklinikum Carl Gustav Carus ( Site 1501)

    Dresden, Saxony, 01307

  • Universitaetsklinik und Poliklinik Halle/Saale ( Site 1502)

    Halle, Saxony-Anhalt, 06120

  • Medizinische Hochschule Hannover ( Site 1505)

    Hanover, Lower Saxony, 30625

  • Universitaetsklinikum Heidelberg ( Site 1509)

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitatsklinikum des Saarlandes ( Site 1513)

    Homburg, Saarland, 66421

  • Universitatsklinikum Leipzig ( Site 1508)

    Leipzig, Saxony, 04103

  • Krankenhaus Neuwittelsbach ( Site 1510)

    Munich, Bavaria, 80639

  • Universitaetsklinik Regensburg ( Site 1503)

    Regensburg, Bavaria, 93053

Other trials in Germany

Spain8 sites

  • Hospital Universitari Vall de Hebron ( Site 1605)

    Barcelona, 08035

  • Hospital Universitario 12 de Octubre ( Site 1603)

    Madrid, 28041

  • Hospital Universitario La Paz ( Site 1610)

    Madrid, 28046

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

    Majadahonda, Madrid, 28222

  • Hospital Universitario de Son Espases ( Site 1611)

    Palma de Mallorca, Balearic Islands, 07120

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

    Salamanca, 37007

  • Hospital Universitario Marques de Valdecilla ( Site 1601)

    Santander, Cantabria, 39008

  • Hospital Virgen de la Salud ( Site 1607)

    Toledo, 45004

Other trials in Spain

Australia7 sites

  • Royal Adelaide Hospital ( Site 1109)

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital ( Site 1106)

    Camperdown, New South Wales, 2050

  • Prince Charles Hospital ( Site 1104)

    Chermside, Queensland, 4032

  • Royal Hobart Hospital ( Site 1107)

    Hobart, Tasmania, 7000

  • Fiona Stanley Hospital ( Site 1103)

    Murdoch, Western Australia, 6150

  • John Hunter Hospital ( Site 1101)

    Newcastle, New South Wales, 2308

  • Princess Alexandra Hospital ( Site 1108)

    Woolloongabba, Queensland, 4102

Other trials in Australia

United Kingdom7 sites

  • Papworth Hospital NHS Foundation Trust ( Site 1208)

    Cambrigge, Cambridgeshire, CB23 0AY

  • Golden Jubilee National Hospital ( Site 1204)

    Glasgow, Glasgow City, G81 4DY

  • Royal Free London NHS Foundation Trust ( Site 1202)

    London, London, City of, NW3 2QG

  • Royal Brompton Hospital ( Site 1206)

    London, London, City of, SW3 6HP

  • Imperial College Healthcare NHS Trust ( Site 1203)

    London, London, City of, W12 OHS

  • Freeman Hospital ( Site 1205)

    Newcastle upon Tyne, NE7 7DN

  • Sheffield Teaching Hospital NHS Foundation Trust ( Site 1207)

    Sheffield, Derbyshire, S10 2JF

Other trials in United Kingdom

South Korea6 sites

  • Chonnam National University Hospital ( Site 3105)

    Gwangju, Kyonggi-do, 61469

  • Gachon University Gil Medical Center ( Site 3103)

    Namdong-Gu, Incheon, 21565

  • Seoul National University Hospital ( Site 3102)

    Seoul, 03080

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

    Seoul, 03722

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

    Seoul, 06591

  • Samsung Medical Center ( Site 3106)

    Seuol, Seoul, 06351

Other trials in South Korea

Italy5 sites

  • Ospedale S. Giuseppe Multimedica ( Site 2403)

    Milan, Lombardy, 20123

  • Azienda Ospedaliera San Gerardo di Monza ( Site 2406)

    Monza, Monza E Brianza, 20900

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

    Naples, 80131

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

    Roma, 161

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

    Trieste, Friuli Venezia Giulia, 34149

Other trials in Italy

Austria4 sites

  • Medizinische Universität Graz ( Site 2003)

    Graz, Styria, 8036

  • Medizinische Universitat Innsbruck ( Site 2004)

    Innsbruck, Tyrol, 6020

  • Ordensklinikum Linz GmbH Elisabethinen ( Site 2002)

    Linz, Upper Austria, 4020

  • Medizinische Universitat Wien ( Site 2001)

    Vienna, State of Vienna, 1090

Other trials in Austria

Brazil4 sites

  • Hospital Madre Teresa ( Site 1804)

    Belo Horizonte, Minas Gerais, 30430-142

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

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital Sao Paulo ( Site 1806)

    São Paulo, São Paulo, 04038-031

  • Instituto do Coracao - HCFMUSP ( Site 1803)

    São Paulo, 05403-000

Other trials in Brazil

Canada4 sites

  • University of Alberta Hospital ( Site 2101)

    Edmonton, Alberta, T6G 2B7

  • McMaster University - HSC ( Site 2105)

    Hamilton, Ontario, L8N 4A6

  • Sir Mortimer B Davis Jewish General Hospital ( Site 2103)

    Montreal, Quebec, H3T 1E2

  • St Boniface General Hospital ( Site 2106)

    Winnepeg, Manitoba, R2H 2A6

Other trials in Canada

Colombia4 sites

  • Fundacion Neumologica Colombiana ( Site 3403)

    Bogota, Cundinamarca, 110131

  • Fundacion Valle Del Lili ( Site 3401)

    Cali, Valle del Cauca Department, 760032

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

    Cali, Valle del Cauca Department, 760042

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

    Medellín, Antioquia, 50034

Other trials in Colombia

Greece4 sites

  • Evangelismos General Hospital of Athens ( Site 3605)

    Athens, Attica, 106 76

  • Onassis Cardiac Surgery Center ( Site 3602)

    Athens, Attica, 176 74

  • Attikon University General Hospital of Athens ( Site 3604)

    Haidari, Attica, 124 62

  • AHEPA University General Hospital of Thessaloniki ( Site 3601)

    Thessaloniki, 546 36

Other trials in Greece

Israel4 sites

  • Assuta Ashdod Medical Center ( Site 1710)

    Ashdod, 7747629

  • Lady Davis Carmel Medical Center ( Site 1705)

    Haifa, 3436212

  • Hadassah Medical Center ( Site 1711)

    Jerusalem, 9112001

  • Sheba Medical Center ( Site 1701)

    Tel HaShomer, 52621

Other trials in Israel

Netherlands4 sites

  • VU Medisch Centrum ( Site 2601)

    Amsterdam, North Holland, 1081 HV

  • Maastricht University Medical Center ( Site 2603)

    Maastricht, Limburg, 6229 HX

  • Radboud University Nijmegen Medical Centre ( Site 2605)

    Nijmegen, Gelderland, 6500 HB

  • Erasmus MC ( Site 2604)

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

Serbia4 sites

  • Clinical Center of Serbia ( Site 2901)

    Belgrade, 11000

  • Institute for pulmonary diseases of Vojvodina ( Site 2906)

    Kamenitz, Juznobacki Okrug, 21204

  • Clinical Center Kragujevac ( Site 2905)

    Kragujevac, Sumadijski Okrug, 34000

  • University Clinical Center Nis ( Site 2904)

    Niš, Nisavski Okrug, 18000

Other trials in Serbia

Portugal3 sites

  • Hospital Garcia de Orta ( Site 3501)

    Almada, Setúbal District, 2801-951

  • Centro Hospitalar E Universitário De Coimbra ( Site 3502)

    Coimbra, 3000-075

  • Hospital Pulido Valente ( Site 3503)

    Lisbon, 1769-001

Other trials in Portugal

Sweden3 sites

  • Skanes Universitetssjukhus Lund ( Site 3203)

    Lund, Skåne County, 22185

  • Norrlands Universitetssjukhus ( Site 3205)

    Umeå, Västerbotten County, 90185

  • Hjart-lungmedicin och klinisk fysiologi ( Site 3204)

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

Taiwan3 sites

  • Kaohsiung Veterans General Hospital ( Site 3702)

    Kaohsiung City, 81362

  • China Medical University Hospital ( Site 3701)

    Taichung, 40447

  • National Cheng Kung University Hospital ( Site 3703)

    Tainan, 704

Other trials in Taiwan

Belgium2 sites

  • Hopital Erasme ( Site 1402)

    Anderlecht, Bruxelles-Capitale, Region de, 1070

  • UZ Gasthuisberg ( Site 1401)

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

Croatia2 sites

  • University Hospital Centre Split city ( Site 3901)

    Split, Split-Dalmatia County, 21000

  • Klinicki Bolnicki Centar Zagreb ( Site 3902)

    Zagreb, Zagreb County, 10000

Other trials in Croatia

Czechia2 sites

  • Institut Klinicke a Experimentalni Mediciny ( Site 2202)

    Prague, Praha 4, 140 21

  • Vseobecna fakultni nemocnice v Praze ( Site 2201)

    Prague, 128 08

Other trials in Czechia

Denmark2 sites

  • Aarhus Universitetshospital, Skejby ( Site 3801)

    Aarhus, Central Jutland, 8200

  • Rigshospitalet ( Site 3802)

    København Ø, Capital Region, 2100

Other trials in Denmark

Poland2 sites

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

    Krakow, Lesser Poland Voivodeship, 31-202

  • Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 2802)

    Warsaw, Masovian Voivodeship, 01-138

Other trials in Poland

New Zealand1 site

  • Waikato District Health Board ( Site 2702)

    Hamilton, Waikato Region, 3204

Other trials in New Zealand

Switzerland1 site

  • UniversitätsSpital Zürich ( Site 3301)

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients

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.

Read the detailed description

This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate sotatercept when added to background PAH therapy in newly diagnosed intermediate- or high risk PAH participants.

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.

Being tested
Sotatercept, Placebo
Keywords
Pulmonary, Hypertension, Sotatercept
Medical subject headings
Pulmonary Arterial Hypertension, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SotaterceptDrug

    Also called MK-7962, ACE-011

    SC injection

  • PlaceboOther

    Placebo-matched SC injection

Study groups in NCT04811092
Study groupRoleWhat they receive
Sotatercept plus background PAH therapyExperimentalParticipants 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.
Receives: Drug: Sotatercept
Placebo plus background therapyPlacebo comparatorParticipants received placebo SC every 21 days plus background PAH therapy.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to ~35 months

Secondary outcomes (13)

  1. 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

    The multicomponent improvement outcome measure is determined by the percentage of participants achieving all of the following at Week 24 relative to baseline:

    • Improvement in 6MWD (increase ≥30 m)
    • Improvement or maintenance/achievement of NT-proBNP (decrease in NT-proBNP ≥30%) or maintenance/achievement of NT-proBNP level <300 ng/L
    • Improvement in WHO FC or maintenance of WHO FC II (indicated by maintaining the same WHO FC or a lower WHO FC by Week 24 relative to baseline) The percentage of participants achieving the multicomponent improvement endpoint is presented.

    Measured: Baseline and Week 24

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

    REVEAL Lite 2.0 risk scoring is used to guide PAH treatment decisions. Total score uses 6 variables with each assessed based on contribution to mortality risk. Variables and sub-score ranges: estimated glomerular filtration rate [eGFR] (0, +1), WHO FC (-1, 0, +1, +2), SBP (0, +1), heart rate (0, +1), 6MWD (-2, -1, 0, +1), and NT-proBNP (-2, 0, +2). Sub-scores are added to a base score of +6 and a total score of 1 to 14 is obtained (≤5=low risk; 6,7=intermediate risk; ≥8=high risk). A higher score = higher risk. Per SAP, participants who did not have a REVEAL risk score at Week 24 were considered as non-responders and multiple imputation was not conducted for this endpoint. Comparisons between this analysis reporting non-imputed data should not be made to other REVEAL analyses which included imputation of missing Week 24 data. The percentage of participants who maintained or achieved a low REVEAL Lite 2.0 score at Week 24 is reported.

    Measured: Baseline and Week 24

  3. Percentage of Participants Who Maintained or Achieved a Low Simplified French Risk Score

    The simplified French Risk Score uses WHO FC, 6MWD, and NT-proBNP to determine the total risk score. A low risk score can be defined as attaining or maintaining all three low-risk criteria: WHO FC I or II, 6MWD > 440m, and NT-proBNP < 300 ng/L. The percentage of participants who maintained or achieved a low risk score at Week 24 versus baseline using the simplified French Risk score calculator is presented.

    Measured: Baseline and Week 24

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

    NT-proBNP is a circulating biomarker that reflects myocardial stretch and is an established biomarker used to determine the ventricular dysfunction in participants with PAH. NT-proBNP was measured at Day 1 (baseline) and at Week 24. The median change from baseline in NT-proBNP at Week 24 is presented.

    Measured: Baseline and Week 24

  5. Percentage of Participants Who Improved in WHO FC or Maintained WHO FC II at 24 Weeks From Baseline

    The severity of an individual's PAH symptoms was graded using the WHO FC system. WHO functional classification for PAH range 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 a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO FC is classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. The percentage of participants who improved in WHO FC or maintained WHO FC II at 24 Weeks from Baseline is presented.

    Measured: Baseline and Week 24

  6. Median Change From Baseline in Six-Minute Walk Distance (6MWD)

    The 6-minute walk distance (6MWD) was measured using the 6-Minute Walk Test (6MWT). The 6MWT measures the distance covered in 6 minutes and is intended to measure changes in functional exercise capacity. Each participant's 6MWD was measured at baseline and at 24 weeks. An increase in the distance walked during the 6MWT indicated improvement in functional exercise capacity. Median change from baseline in 6MWD at Week 24 is reported.

    Measured: Baseline and Week 24

  7. Overall Survival (OS)

    Overall survival is defined as the time from randomization to date of death due to any cause. OS is presented.

    Measured: Up to ~35 Months

  8. Mean Change From Baseline in the Physical Impacts Domain Score of Pulmonary Arterial Hypertension Symptoms and Impact (PAH-SYMPACT)®

    The PAH SYMPACT is a 23-item questionnaire to measure pulmonary arterial hypertension (PAH)-related symptoms and impact of PAH on daily life. The physical impact domain consists of walking slowly on a flat surface, walking quickly on a flat surface, walking uphill, carrying things, doing light indoor household chores, washing, or dressing oneself, and needing help from others. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (not difficult at all) to 4 (extremely difficult). A domain score was calculated by summing the individual responses for each item and dividing by the number of impact items (range: 0=no physical impact to 4=severe physical impact). A higher score indicated more severe physical impact. Mean change from baseline in responses in physical symptoms of the PAH-SYMPACT questionnaire at Week 24 is reported.

    Measured: Baseline and Week 24

  9. Mean Change From Baseline in the Cardiopulmonary Symptoms Domain Score of PAH-SYMPACT®

    The PAH SYMPACT is a 23-item questionnaire to measure PAH-related symptoms and impact of PAH on daily life. The cardiopulmonary symptoms consist of shortness of breath, fatigue, lack of energy, swelling in the ankles or legs, swelling in the stomach area, and cough. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (no symptom at all) to 4 (very severe symptoms). The mean individual symptom item score was determined for each of the 6 items and a domain score was calculated by summing the mean individual symptom item scores and dividing by the number of items (range: 0=no cardiopulmonary symptoms to 4=severe cardiopulmonary symptoms). A higher score indicated more severe symptoms experienced. Mean change from baseline in cardiopulmonary symptoms of the PAH-SYMPACT questionnaire at Week 24 is reported.

    Measured: Baseline and Week 24

  10. Mean Change From Baseline in the Cognitive/Emotional Impacts Domain Score of PAH-SYMPACT®

    The PAH SYMPACT is a 23-item questionnaire to measure PAH-related symptoms and impact of PAH on daily life. The Cognitive/Emotional Impact domain consists of thinking clearly, feeling sad, feeling worried, and feeling frustrated. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (not difficult at all) to 4 (extremely difficult). A domain score was calculated by summing the individual responses for each item and dividing by the number of impact items (range: 0=no cognitive/emotional impact to 4=severe cognitive/emotional impact). A higher score indicated more severe cognitive/emotional impact. Mean change from baseline in responses in the Cognitive/Emotional Impacts Domain Score of the PAH-SYMPACT questionnaire at Week 24 is reported.

    Measured: Baseline and Week 24

  11. Percentage of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who experienced an AE are presented.

    Measured: Up to ~35 Months

  12. Percentage of Participants Who Discontinued Study Treatment Due to AEs

    An AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who discontinued study treatment due to an AE are presented.

    Measured: Up to ~35 months

  13. Number of Participants Who Had Anti-drug Antibodies (ADAs) to Sotatercept

    Blood samples collected at designated timepoints were used to determine the ADA response to sotatercept. The number of participants who had ADAs to sotatercept over time is presented.

    Measured: Up to ~35 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2021
  2. Study start18 Mar 2022
  3. Primary completion3 Apr 2025
  4. Study completion3 Apr 2025

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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04811092
Sponsor's protocol ID
7962-005
Other IDs
A011-13, MK-7962-005, 2023-509139-16-00, U1111-1309-6312, 2021-000199-12, 2023
Acronym
HYPERION
Status last verified
May 2026
First submitted
16 Mar 2021
Last updated
8 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 41025556

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sotatercept in people with Pulmonary Arterial Hypertension, run by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA at 152 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 152 sites in United States, France, Argentina, Germany, Spain and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Time to Clinical Worsening (time frame: Up to ~35 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04811092, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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