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Pulmonary Arterial HypertensionPhase 3SOTERIANCT07218029

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

A Phase 3 study testing Sotatercept in people with Pulmonary Arterial Hypertension, run by Merck Sharp & Dohme LLC at 137 sites in 27 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. 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?
No, everyone receives an active treatment
How many people
815 participants
Where
137 sitesin 27 countries
Study dates
12 May 2021to 7 Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • The main inclusion criteria include but are not limited to the following:
  • Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
  • Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements
  • Must have the ability to understand and provide documented informed consent

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Did not participate in a sotatercept PAH parent study
  • Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
  • Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
  • Is a female who is pregnant or breastfeeding
  • Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
  • Is currently enrolled in another investigational product study other than a sotatercept study
  • Is incapacitated

Trial locations and contacts

137 sites in 27 countries.

137 sites in 27 countries

United States36 sites

  • The Emory Clinic ( Site 1030)

    Atlanta, Georgia, 30322

  • University of Colorado Hospital ( Site 1013)

    Aurora, Colorado, 80045

  • Johns Hopkins University ( Site 1036)

    Baltimore, Maryland, 21287

  • Tufts Medical Center ( Site 1012)

    Boston, Massachusetts, 02111

  • Brigham and Women's Hospital ( Site 1014)

    Boston, Massachusetts, 02115

  • Medical University of South Carolina ( Site 1003)

    Charleston, South Carolina, 29425

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

    Cincinnati, Ohio, 45219

  • University of Cincinnati Medical Center ( Site 1035)

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Main ( Site 1065)

    Cleveland, Ohio, 44195

  • Ohio State University Wexner Medical Center ( Site 1032)

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center ( Site 1038)

    Dallas, Texas, 75390

  • Duke University Medical Center ( Site 1026)

    Durham, North Carolina, 27710-4000

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

    Houston, Texas, 77030

  • Houston Methodist Hospital ( Site 1009)

    Houston, Texas, 77030

  • Mayo Clinic Jacksonville ( Site 1045)

    Jacksonville, Florida, 32224

  • University of Kansas Medical Center ( Site 1020)

    Kansas City, Kansas, 66160

  • University of California San Diego Health ( Site 1002)

    La Jolla, California, 92039

  • Norton Pulmonary Specialists ( Site 1066)

    Louisville, Kentucky, 40202

  • Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)

    Milwaukee, Wisconsin, 53226

  • University of Minnesota ( Site 1062)

    Minneapolis, Minnesota, 55455

  • Weill Cornell Medical Center ( Site 1046)

    New York, New York, 10021

  • University Of Nebraska Medical Center ( Site 1053)

    Omaha, Nebraska, 68198-5990

  • UC Irvine Health Medical Center ( Site 1086)

    Orange, California, 92868

  • AdventHealth Orlando ( Site 1058)

    Orlando, Florida, 32803

  • Pulmonary Associates, PA ( Site 1008)

    Phoenix, Arizona, 85032

  • University of Pittsburgh Medical Center - Presbyterian Hosp. ( Site 1059)

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health & Science University ( Site 1054)

    Portland, Oregon, 97239

  • Rhode Island Hospital ( Site 1033)

    Providence, Rhode Island, 02903

  • UC Davis - Medial Center ( Site 1064)

    Sacramento, California, 95817

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

    San Francisco, California, 94143

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

    Santa Barbara, California, 93105-5316

  • Arizona Pulmonary Specialists ( Site 1010)

    Scottsdale, Arizona, 85258

  • Tampa General Hospital ( Site 1043)

    Tampa, Florida, 33606

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

    Torrance, California, 90502

  • University of Arizona ( Site 1006)

    Tucson, Arizona, 85724-0001

  • George Washington University Medical Faculty Associates ( Site 1025)

    Washington D.C., District of Columbia, 20037

Other trials in United States

France13 sites

  • CHU Angers ( Site 1313)

    Angers, Maine-et-Loire, 49100

  • Hopital Cavale Blanche ( Site 1314)

    Brest, Finistere, 29609

  • CHU de Grenoble Hopital Nord ( Site 1303)

    La Tronche, Isere, 38700

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

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

  • Institut Coeur Poumon - CHRU de Lille ( Site 1306)

    Lille, Hauts-de-France, 59037

  • Hôpital Louis Pradel ( Site 1317)

    Lyon, Rhone, 69677

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

    Nice, Alpes-Maritimes, 06300

  • CHU Bordeaux Haut-Leveque ( Site 1312)

    Pessac, Aquitaine, 33604

  • CHU de la Miletrie Poitiers ( Site 1316)

    Poitiers, Vienne, 86021

  • Centre Hospitalier Universitaire de Saint Étienne- Hôpital Nord-Medecine Vasculaire et Therapeutique ( Site 1302)

    Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055

  • Hopital Nord Laennec ( Site 1309)

    Saint-Herblain, Loire-Atlantique, 44800

  • Nouvel Hôpital Civil (NHC) ( Site 1307)

    Strasbourg, Bas-Rhin, 67000

  • Hopital Larrey ( Site 1315)

    Toulouse, Haute-Garonne, 31400

Other trials in France

Germany10 sites

  • DRK Kliniken Berlin Westend ( Site 1507)

    Berlin, 14050

  • Universitaetsklinikum Koeln ( Site 1511)

    Cologne, North Rhine-Westphalia, 50937

  • Universitaetsklinikum Carl Gustav Carus ( Site 1501)

    Dresden, Saxony, 01307

  • UKGM Gießen/Marburg ( Site 1512)

    Giessen, Hesse, 35392

  • Universitätsklinikum Halle ( Site 1502)

    Halle, Saxony-Anhalt, 06120

  • Medizinische Hochschule Hannover ( Site 1505)

    Hanover, Lower Saxony, 30625

  • Thoraxklinik-Heidelberg gGmbH ( Site 1509)

    Heidelberg, Baden-Wurttemberg, 69126

  • Universitätsklinikum Leipzig ( Site 1508)

    Leipzig, Saxony, 04103

  • Krankenhaus Neuwittelsbach ( Site 1510)

    Munich, Bavaria, 80639

  • Universitaetsklinik Regensburg ( Site 1503)

    Regensburg, Bavaria, 93053

Other trials in Germany

Spain9 sites

  • Hospital Universitari Vall D Hebron ( Site 1605)

    Barcelona, Catalonia, 08035

  • Hospital Clinic de Barcelona ( Site 1602)

    Barcelona, 08036

  • Hospital Universitario 12 de Octubre ( Site 1603)

    Madrid, Madrid, Comunidad de, 28041

  • Hospital Universitario La Paz ( Site 1610)

    Madrid, 28046

  • Hospital General Universitario Ramon y Cajal ( Site 1609)

    Madrid, 28048

  • 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 Marques de Valdecilla ( Site 1601)

    Santander, Cantabria, 39008

  • HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1607)

    Toledo, 45007

Other trials in Spain

Argentina7 sites

  • Sanatorio Allende ( Site 1908)

    Córdoba, X5021FPQ

  • Instituto de Investigaciones Clinicas Quilmes ( Site 1903)

    Quilmes, Buenos Aires, B1878GEG

  • Instituto Médico Río Cuarto ( Site 1907)

    Río Cuarto, Córdoba Province, X5800AEV

  • Sanatorio Parque ( Site 1905)

    Rosario, Santa Fe Province, S2000CUB

  • Instituto Cardiovascular de Rosario ( Site 1906)

    Rosario, Santa Fe Province, S2000DSR

  • Hospital Provincial del Centenario ( Site 1912)

    Rosario, Santa Fe Province, S2002KDS

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

    Santa Fe, S3000EOZ

Other trials in Argentina

Australia7 sites

  • Royal Adelaide Hospital ( Site 1109)

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital ( Site 1106)

    Camperdown, New South Wales, 2050

  • The Prince Charles Hospital ( Site 1104)

    Chermside, New South Wales, 4032

  • Saint Vincents Hospital Sydney ( Site 1102)

    Darlinghurst, New South Wales, 2010

  • Royal Hobart Hospital ( Site 1107)

    Hobart, Tasmania, 7000

  • Fiona Stanley Hospital ( Site 1103)

    Murdoch, Western Australia, 6150

  • John Hunter Hospital ( Site 1101)

    New Lambton Heights, New South Wales, 2305

Other trials in Australia

United Kingdom7 sites

  • Papworth Hospital NHS Foundation Trust ( Site 1208)

    Cambridge, Cambridgeshire, CB2 0AY

  • Golden Jubilee National Hospital ( Site 1204)

    Glasgow, Glasgow City, G81 4DY

  • Royal Free Hospital ( Site 1202)

    London, London, City of, NW3 2QG

  • Royal Brompton Hospital ( Site 1206)

    London, London, City of, SW3 6NP

  • Hammersmith Hospital ( Site 1203)

    London, London, City of, W12 0HS

  • Freeman Hospital ( Site 1205)

    Newcastle upon Tyne, NE7 7DN

  • Royal Hallamshire Hospital ( Site 1207)

    Sheffield, S10 2JF

Other trials in United Kingdom

Brazil5 sites

  • Hospital Madre Teresa ( Site 1804)

    Belo Horizonte, Minas Gerais, 30441-070

  • Hospital Dia do Pulmao ( Site 1802)

    Blumenau, Santa Catarina, 89010-000

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

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital Sao Paulo ( Site 1806)

    São Paulo, São Paulo, 04024-002

  • Instituto do Coracao - HCFMUSP ( Site 1803)

    São Paulo, 05403-000

Other trials in Brazil

Israel5 sites

  • Carmel Hospital ( Site 1705)

    Haifa, 3436212

  • Haddasah Medical Center ( Site 1711)

    Jerusalem, 9112001

  • Meir Medical Center ( Site 1707)

    Kfar Saba, 4428164

  • Rabin Medical Center ( Site 1703)

    Petah Tikva, 4941492

  • Sheba Medical Center ( Site 1701)

    Ramat Gan, 5265601

Other trials in Israel

Italy4 sites

  • Ospedale San Giuseppe ( Site 2403)

    Milan, Milano, 20123

  • Fondazione IRCCS San Gerardo dei Tintori ( Site 2406)

    Monza, Lombardy, 20900

  • A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 2407)

    Naples, 80131

  • AOU Policlinico Umberto I ( Site 2402)

    Rome, Roma, 00161

Other trials in Italy

Canada3 sites

  • Peter Lougheed Centre ( Site 2102)

    Calgary, Alberta, T1Y 6J4

  • University of Alberta Hospital ( Site 2101)

    Edmonton, Alberta, T6G 2B7

  • St. Joseph's Healthcare Hamilton ( Site 2105)

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

Greece3 sites

  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3604)

    Athens, Attica, 124 62

  • Onassis Cardiac Surgery Center ( Site 3602)

    Athens, Attica, 176 74

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

    Thessaloniki, 546 36

Other trials in Greece

Serbia3 sites

  • University Clinical Hospital Center of Serbia ( Site 2901)

    Belgrade, Beograd, 11000

  • Institute for Cardiovascular Diseases Dedinje ( Site 2903)

    Belgrade, 11000

  • Institute for pulmonary diseases of Vojvodina ( Site 2906)

    Novi Sad, Beograd, 21000

Other trials in Serbia

South Korea3 sites

  • Gachon University Gil Medical Center ( Site 3103)

    Incheon, 21565

  • Severance Hospital, Yonsei University Health System ( Site 3101)

    Seoul, 03722

  • Samsung Medical Center ( Site 3106)

    Seoul, 06351

Other trials in South Korea

Belgium2 sites

  • Université Libre de Bruxelles - Hôpital Erasme ( Site 1402)

    Brussels, Bruxelles-Capitale, Region de, 1070

  • UZ Leuven ( Site 1401)

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

Colombia2 sites

  • Fundación Neumológica Colombiana ( Site 3403)

    Bogotá, Bogota D.C., 110131

  • Clínica Imbanaco S.A.S ( Site 3404)

    Cali, Valle del Cauca Department, 760042

Other trials in Colombia

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

Mexico2 sites

  • Instituto Nacional de Cardiologia Ignacio Chavez ( Site 2503)

    Mexico City, Mexico City, 14080

  • Unidad de Investigacion Clinica en Medicina, S.C. ( Site 2505)

    Monterrey, Nuevo León, 64718

Other trials in Mexico

Netherlands2 sites

  • Amsterdam UMC, locatie VUmc ( Site 2601)

    Amsterdam, North Holland, 1081 HV

  • Radboud University Nijmegen Medical Centre ( Site 2605)

    Nijmegen, Gelderland, 6525 GA

Other trials in Netherlands

Poland2 sites

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

    Krakow, Lesser Poland Voivodeship, 31-202

  • Europejskie Centrum Zdrowia Otwock ( Site 2802)

    Otwock, Masovian Voivodeship, 05-400

Other trials in Poland

Portugal2 sites

  • Hospital Garcia de Orta ( Site 3501)

    Almada, Setúbal District, 2805-267

  • Hospital Pulido Valente ( Site 3503)

    Lisbon, 1769-001

Other trials in Portugal

Taiwan2 sites

  • Kaohsiung Veteran General Hospital ( Site 3702)

    Kaohsiung City, 813

  • National Cheng Kung University Hospital ( Site 3703)

    Tainan, 704302

Other trials in Taiwan

Croatia1 site

  • Klinicki Bolnicki Centar Split ( Site 3901)

    Split, Split-Dalmatia County, 21000

Other trials in Croatia

New Zealand1 site

  • Waikato Hospital ( Site 2702)

    Hamilton, Waikato Region, 3240

Other trials in New Zealand

Sweden1 site

  • Sahlgrenska Universitetssjukhuset ( Site 3201)

    Gothenburg, Västra Götaland County, 41346

Other trials in Sweden

Switzerland1 site

  • UniversitätsSpital Zürich ( Site 3301)

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)

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.

Read the detailed description

LTFU PAH sotatercept study MK-7962-004 (Obsolete Identifier: NCT04796337) has been incorporated into the current MK-7962-038 (NCT07218029) study for administrative reasons. The MK-7962-004 study is no longer enrolling participants and will be formally closed. Only those who participated in MK-7962-004 may be eligible to continue into MK-7962-038.

Being tested
Sotatercept
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

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

  • SotaterceptBiological

    Also called MK-7962, ACE-011, ActRIIA-IgG1Fc, WINREVAIR®

    Sotatercept SC injection every 3 weeks

Study groups in NCT07218029
Study groupRoleWhat they receive
SotaterceptExperimentalParticipants 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.
Receives: Biological: Sotatercept

What is being measured

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

  1. Number of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

    Measured: Up to approximately 90 months

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

    Measured: Up to approximately 86 months

  3. Number of Participants with Detectable Anti-Drug Antibodies (ADAs)

    ADAs will be detected in serum. The number of participants with detectable ADAs will be reported.

    Measured: Up to approximately 88 months

  4. Laboratory parameters (Hematology): Concentration of Platelets and Hemoglobin

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

    Measured: Up to approximately 88 months

  5. Laboratory parameters (Chemistry): Concentration of Creatinine, Total Bilirubin, and Alanine Aminotransferase (ALT)

    Blood samples will be collected to determine the concentration of creatinine, total bilirubin, and ALT.

    Measured: Up to approximately 86 months

  6. Change From Baseline in Body Weight

    Change from baseline in body weight will be reported.

    Measured: Baseline and up to approximately 86 months

  7. Change From Baseline in Blood Pressure

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

    Measured: Baseline and up to approximately 86 months

  8. 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.

    Measured: Baseline and up to approximately 86 months

Secondary outcomes (5)

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

    The 6MWD is the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD will be reported.

    Measured: Baseline and up to approximately 48 months

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

    NT-proBNP is a circulating biomarker that reflects myocardial stretch. The change from baseline in NT-proBNP levels will be reported.

    Measured: Baseline and up to approximately 48 months

  3. Change From Baseline in the Percentage of Participants Who Improve or Show Maintenance in Modified New York Heart Association/ World Health Organization Classification of Functional Status (WHO FC)

    The severity of participant's PAH symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform physical activity without any symptoms, dyspnea at rest). Participants will be classified as "Improved", "No change", or "Worsened". Improved = reduction in WHO FC; No Change = no change in WHO FC; Worsened = increase in WHO FC. The change from baseline in the percentage of participants who improve or show maintenance in WHO FC will be reported.

    Measured: Baseline and up to approximately 48 months

  4. Change From Baseline in Pulmonary Vascular Resistance (PVR)

    PVR is a hemodynamic variable of pulmonary circulation and is measured by right heart catheterization. The change from baseline in PVR will be reported.

    Measured: Baseline and up to approximately 48 months

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

    The simplified French Risk scoring system is based on the 2015 European Society of Cardiology/European Respiratory Society guidelines for the diagnosis and treatment of pulmonary hypertension (PH). Noninvasive parameters (WHO FC, 6MWD, NT-proBNP levels) will be used to determine the score. 'Low risk' is defined as maintaining or achieving all 3 low-risk criteria: WHO FC I or II, 6MWD >440 meters, and NT-proBNP <300 ng/L. The change from baseline in percentage of participants who maintain or achieve a low risk simplified French Risk score will be reported.

    Measured: Baseline and up to approximately 48 months

Timeline

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

  1. First posted20 Oct 2025
  2. Study start12 May 2021
  3. Primary completion7 Dec 2028 (estimated)
  4. Study completion7 Dec 2028 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
815 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07218029
Sponsor's protocol ID
7962-038
Other IDs
2025-521970-33-00, U1111-1321-4943, MK-7962-038, MK-7962-004, 2025
Acronym
SOTERIA
Status last verified
Oct 2026
First submitted
7 Oct 2025
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 39978862

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sotatercept in people with Pulmonary Arterial Hypertension, run by Merck Sharp & Dohme LLC at 137 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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 137 sites in United States, France, Germany, Spain, Argentina 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to approximately 90 months). The study lists 8 primary outcomes in all. 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 NCT07218029, 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 Oct 2026.

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