Clinical trial • Phase III • Cardiology

SOTATERCEPT for Pulmonary arterial hypertension

Phase III trial of SOTATERCEPT for Pulmonary arterial hypertension. open-label, none/not specified-controlled. 418 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Pulmonary arterial hypertension
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
11-08-2025
First CTIS Authorization Date
01-12-2025

Trial design

open-label, none/not specified-controlled Phase III trial across 56 sites in Croatia, Czechia, Spain and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
418
Trial Duration For Participant
1080

Eligibility

Recruits 418 isVulnerablePopulationSelected=false. Consent is obtained from adult participants via country-specific L1_ICF main consent documents. Country-specific optional consent modules for pregnancy, pregnant partner, pregnancy follow-up and infant follow-up are included in the submission (e.g. Poland: 'L1_ICF_Optional_infant follow-up_POL_PL_IN'; multiple 'Optional_pregnancy' forms across member states). No specific assent procedures for minors are specified..

Vulnerable Population
isVulnerablePopulationSelected=false. Consent is obtained from adult participants via country-specific L1_ICF main consent documents. Country-specific optional consent modules for pregnancy, pregnant partner, pregnancy follow-up and infant follow-up are included in the submission (e.g. Poland: 'L1_ICF_Optional_infant follow-up_POL_PL_IN'; multiple 'Optional_pregnancy' forms across member states). No specific assent procedures for minors are specified.

Inclusion criteria

  • {"criterion_text":"- Has completed the MK-7962-004 study requirements."}
  • {"criterion_text":"- Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements."}

Exclusion criteria

  • {"criterion_text":"- Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study."}
  • {"criterion_text":"- Is currently enrolled in another investigational product study other than a sotatercept study."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of Participants Who Experience an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants who experience any adverse event (AE)."}
  • {"endpoint_text":"- Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study treatment due to an adverse event."}
  • {"endpoint_text":"- Number of Participants With Detectable Anti-drug Antibodies (ADAs)","definition_or_measurement_approach":"Number of participants with detectable anti-drug antibodies measured by immunogenicity assays."}
  • {"endpoint_text":"- Hematology Parameters: Concentration of Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin, and Hematocrit","definition_or_measurement_approach":"Laboratory hematology measurements of RBC, WBC, platelet count, hemoglobin and hematocrit concentrations."}
  • {"endpoint_text":"- Chemistry Parameters: Concentration of Blood Urea,Creatinine,Total & Direct Bilirubin,Aspartate Aminotransferase,Alanine Transaminase,Alkaline Phosphatase,Sodium,Potassium,Chloride,Calcium,Phosphorous,Glucose,Magnesium,Carbon Dioxide, & Albumin","definition_or_measurement_approach":"Laboratory chemistry measurements of the listed blood analytes."}
  • {"endpoint_text":"- Change From Baseline in Body Weight","definition_or_measurement_approach":"Change from baseline measured body weight (difference versus baseline)."}
  • {"endpoint_text":"- Change From Baseline in Blood Pressure","definition_or_measurement_approach":"Change from baseline measured blood pressure (difference versus baseline)."}
  • {"endpoint_text":"- Change From Baseline in Electrocardiogram (ECG)","definition_or_measurement_approach":"Change from baseline in ECG parameters compared to baseline ECG."}

Secondary endpoints

  • {"endpoint_text":"- Change From Baseline in 6-Minute Walk Distance (6MWD)","definition_or_measurement_approach":"Change from baseline in distance walked in 6-minute walk test."}
  • {"endpoint_text":"- Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels","definition_or_measurement_approach":"Change from baseline in NT-proBNP concentrations measured in blood."}
  • {"endpoint_text":"- 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)","definition_or_measurement_approach":"Proportion of participants who improve or maintain WHO functional class (modified NYHA/WHO FC) versus baseline."}
  • {"endpoint_text":"- Change From Baseline in Pulmonary Vascular Resistance (PVR)","definition_or_measurement_approach":"Change from baseline in pulmonary vascular resistance measured by hemodynamic assessment."}
  • {"endpoint_text":"- Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low-Risk Score Using the Simplified French Risk Score Calculator","definition_or_measurement_approach":"Proportion of participants maintaining or achieving a low-risk score per the Simplified French Risk Score versus baseline."}

Recruitment

Planned Sample Size
418
Recruitment Window Months
37
Consent Approach
Informed consent is obtained from adult participants using country-specific L1_ICF main consent documents (multiple language versions provided per Member State). Optional consent modules (pregnancy, pregnant partner, pregnancy follow-up, infant follow-up, survival follow-up, genetic consent, GDPR/privacy) are included as country-specific addenda. No child assent procedures are specified in the provided documents.

Geography

Total Number Of Sites
56
Total Number Of Participants
389

Croatia

Earliest CTIS Part Ii Submission Date
30-10-2025
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
39
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
KBC Split
Department Name
Cardiology
Contact Person Name
Mislav Lozo
Contact Person Email
mislav.lozo@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
31-10-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
32
Number Of Sites
2
Number Of Participants
24

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Centrum pro plicní hypertenzi VFN II.interní klinika VFN a 1.LF UK
Contact Person Name
Pavel Jansa
Contact Person Email
pavel.jansa@vfn.cz
Site Name
Institute For Clinical And Experimental Medicine
Department Name
Centrum pro léčbu plicní hypertense, klinika kardiologie
Contact Person Name
Hikmet Al-Hiti
Contact Person Email
hikmet.al-hiti@ikem.cz

Spain

Earliest CTIS Part Ii Submission Date
31-10-2025
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
39
Number Of Sites
9
Number Of Participants
47

Sites

Site Name
Hospital Universitario De Toledo
Department Name
Cardiology
Contact Person Name
Maria Lázaro Salvador
Contact Person Email
maria.lasal@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Neumology
Contact Person Name
Isabel Blanco Vich
Contact Person Email
iblanco2@clinic.cat
Site Name
Hospital Universitario La Paz
Department Name
Neumology
Contact Person Name
Sergio Alcolea Batres
Contact Person Email
alcobatres@yahoo.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Neumology
Contact Person Name
Jose Manuel Cifrián Martinez
Contact Person Email
josemanuel.cifrian@scsalud.es
Site Name
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Department Name
Neumology
Contact Person Name
Cristina Berastegui Garcia
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Neumology
Contact Person Name
Maria Jesus del Cerro Marin
Contact Person Email
majecerro@yahoo.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Cardiology
Contact Person Name
Manuel Gómez Bueno
Contact Person Email
mgomezbueno@secardiologia.es
Site Name
University Hospital Son Espases
Department Name
Neumology
Contact Person Name
Ernest Sala Llinás
Contact Person Email
ernest.sala@ssib.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Cardiology
Contact Person Name
Pilar Escribano Subías

Sweden

Earliest CTIS Part Ii Submission Date
28-10-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
35
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Kardiologens forskningsenhet
Contact Person Name
Clara Hjalmarsson
Contact Person Email
clara.hjalmarsson@vgregion.se

Denmark

Earliest CTIS Part Ii Submission Date
28-10-2025
Latest Decision Or Authorization Date
25-02-2026
Processing Time Days
120
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Rigshospitalet
Department Name
Cardiology Trial Unit 9631
Contact Person Name
Mads Ersbøll
Site Name
Region Midtjylland
Department Name
Dept. of Hematology
Contact Person Name
Søren Mellemkjær
Contact Person Email
Soren.Mellemkjaer@rm.dk

France

Earliest CTIS Part Ii Submission Date
28-08-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
96
Number Of Sites
13
Number Of Participants
71

Sites

Site Name
Bicetre Hospital
Department Name
Pneumology department
Contact Person Name
David Montani
Contact Person Email
david.montani@bct.aphp.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Pneumology department
Contact Person Name
Delphine Horeau-Langlard
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Pneumology department
Contact Person Name
Marianne Riou
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Pneumology department
Contact Person Name
Cécile Tromeur
Contact Person Email
cecile.tromeur@chu-brest.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Cardiology and cardiovascular diseases department
Contact Person Name
François Picard
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Respiratory and Sleep medicine department
Contact Person Name
Frédéric Gagnadoux
Contact Person Email
fgagnadoux@chu-angers.fr
Site Name
Hospices Civils De Lyon
Department Name
Pneumology department
Contact Person Name
Vincent Cottin
Contact Person Email
vincent.cottin@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Pneumology department
Contact Person Name
Etienne-Marie Jutant
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
vascular medicine and therapeutics department
Contact Person Name
Laurent Bertoletti
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Cardiology department
Contact Person Name
Delphine Baudouy
Contact Person Email
baudouy.d@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Pneumology department
Contact Person Name
Cécile Tromeur
Contact Person Email
cecile.tromeur@chu-brest.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Pneumology department
Contact Person Name
Bruno Degano
Contact Person Email
bdegano@chu-grenole.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Cardiology department
Contact Person Name
Pascal De Groote
Contact Person Email
pascal.degroote@chu-lille.fr

Belgium

Earliest CTIS Part Ii Submission Date
13-11-2025
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
22
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
UZ Leuven
Department Name
Pneumology
Contact Person Name
Marion Delcroix
Contact Person Email
marion.delcroix@uzleuven.be
Site Name
Hopital Erasme
Department Name
Pneumology
Contact Person Name
Jean-Luc Vachiery

Germany

Earliest CTIS Part Ii Submission Date
14-11-2025
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
20
Number Of Sites
12
Number Of Participants
148

Sites

Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Department für Innere Medizin Innere Medizin I (Gastroenterologie, Pneumologie)
Contact Person Name
Stephan Eisenmann
Contact Person Email
stephan.eisenmann@uk-halle.de
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Medizinische Klinik und Poliklinik II
Contact Person Name
Ardeschir Ghofrani
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Klinik für Innere Medizin V - Pneumologie, Allergologie, Beatmungs- und Umweltmedizin
Contact Person Name
Albert Omlor
Contact Person Email
albert.omlor@uks.eu
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik für Innere Medizin II-Kardiologie, Pneumologie, Internistische Intensivmedizin
Contact Person Name
Stefan Stadler
Contact Person Email
stefan.stadler@ukr.de
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie
Contact Person Name
Hans-Jürgen Seyfarth
Site Name
Universitaetsklinikum Koeln AöR
Department Name
Innere Medizin III
Contact Person Name
Stephan Rosenkranz
Contact Person Email
stephan.rosenkranz@uk-koeln.de
Site Name
Krankenhaus Neuwittelsbach
Department Name
Zentrum für Lungenhochdruck
Contact Person Name
Hanno Leuchte
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Universitaetsklinikum Heidelberg
Contact Person Name
Ekkehard Grünig
Site Name
DRK Kliniken Berlin
Department Name
Klinik für Innere Medizin - Kardiologie
Contact Person Name
Christian Opitz
Contact Person Email
c.opitz@drk-kliniken-berlin.de
Site Name
Technische Universitaet Dresden
Department Name
Innere Medizin
Contact Person Name
Michael Halank
Contact Person Email
pulmo.studien@ukdd.de
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Pneumologie
Contact Person Name
Marius Hoeper
Contact Person Email
hoeper.marius@mh-hannover.de
Site Name
Universitaetsklinikum des Saarlandes AöR (additional entry)

Greece

Earliest CTIS Part Ii Submission Date
28-08-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
96
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
1st Cardiology Department
Contact Person Name
Georgios Giannakoulas
Contact Person Email
g.giannakoulas@gmail.com
Site Name
Onassis Cardiac Surgery Center
Department Name
Cardiology Department
Contact Person Name
Dimitrios Tsiapras
Contact Person Email
itsagkaris@med.uoa.gr
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Department of Critical Care
Contact Person Name
Iraklis Tsagkaris
Contact Person Email
dtsiapras@hotmail.com

Italy

Earliest CTIS Part Ii Submission Date
18-09-2025
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
78
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Azienda Ospedaliera Dei Colli
Department Name
Cardiologia SUN Centro per la Diagnosi e Terapia dell'Ipertensione Polmonare
Contact Person Name
Michele D'ALTO
Contact Person Email
mic.dalto@tin.it
Site Name
Multimedica S.p.A.
Department Name
Ambulatorio Pneumologia
Contact Person Name
Sergio HARARI
Contact Person Email
sharari@ilpolmone.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
S.C. Pneumologia Centro di Ricerca di fase I
Contact Person Name
Giuseppe PACIOCCO
Contact Person Email
giuseppe.paciocco@unimib.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
U.O.C. Malattie Cardiovascolari
Contact Person Name
Silvia PAPA
Contact Person Email
silviapapa83@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
18-11-2025
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
20
Number Of Sites
2
Number Of Participants
27

Sites

Site Name
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Department Name
Szpital im. Fryderyka Chopina Oddział Kardiologiczny
Contact Person Name
Marcin Kurzyna
Contact Person Email
marcin.kurzyna@ecz-otwock.pl
Site Name
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Department Name
Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego
Contact Person Name
Grzegorz Kopeć
Contact Person Email
g.kopec@szpitaljp2.krakow.pl

Portugal

Earliest CTIS Part Ii Submission Date
01-10-2025
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
65
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
Cardiology
Contact Person Name
Filipa Ferreira
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Cardiology
Contact Person Name
Rui Plácido
Contact Person Email
rui.placido@ulssm.min-saude.pt

Netherlands

Earliest CTIS Part Ii Submission Date
18-11-2025
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
16
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Amsterdam UMC Stichting
Department Name
Longgeneeskunde
Contact Person Name
Anton Vonk Noordegraaf
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Pulmonary Diseases
Contact Person Name
Karin Boomars
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Rheumatology
Contact Person Name
Madelon Vonk
Contact Person Email
trials.reuma@radboudumc.nl

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Pra International
Responsibilities
Imaging - central reader for ECHO; Imaging - central reader for ECG (multiple Pra entries)
Name
PPD Global Central Labs
Responsibilities
Central lab services
Name
Almac Clinical Technologies LLC
Responsibilities
Data/IR support
Name
QPS LLC
Responsibilities
Central lab services

Third parties

  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pra International","duties_or_roles":"Imaging- Central reader for ECHO","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Central lab services (sponsor duties code 4)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pra International","duties_or_roles":"Imaging- Central reader for ECG","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"Data management / IR support (sponsor duties code 3)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"QPS LLC","duties_or_roles":"Central laboratory services (sponsor duties code 4)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
SOTATERCEPT (sotatercept, MK-7962)
Active Substance
SOTATERCEPT
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Mixed: product entries include prodAuthStatus=1 (PRD9659365/PRD9659366) and prodAuthStatus=2 (SUB189200) as provided in product dictionary
Orphan Designation
Yes
Dose Levels
Max daily dose amount 0.7 mg/kg; max total dose amount 37 (units mg/kg as provided)
Maximum Dose
37 mg/kg (max total amount as provided)
Combination Treatment
Yes

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