Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008) (MOONBEAM)

April 16, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care

The primary objectives of the study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to <18 years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC). There is no formal hypothesis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • The Children's Hospital at Westmead ( Site 0001)
        • Contact:
          • Study Coordinator
          • Phone Number: +61298452345
  • Colombia
    • Antioquia
      • Rionegro, Antioquia, Colombia, 054040
        • Recruiting
        • Clinica Somer-Unidad de Investigacion y Docencia ( Site 0205)
        • Contact:
          • Study Coordinator
          • Phone Number: +573003358838
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Recruiting
        • Fundación Valle del Lili ( Site 0200)
        • Contact:
          • Study Coordinator
          • Phone Number: +576023319090
      • Cali, Valle del Cauca Department, Colombia, 760042
        • Recruiting
        • Clínica Imbanaco S.A.S ( Site 0203)
        • Contact:
          • Study Coordinator
          • Phone Number: +576023851000
  • France
      • Paris, France, 75015
        • Recruiting
        • Hôpital Universitaire Necker Enfants Malades ( Site 0300)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 1 71 39 66 22
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Recruiting
        • CHU de Toulouse - Hôpital des Enfants ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: +33534558597
    • Provence-Alpes-Côte d'Azur Region
      • Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
        • Recruiting
        • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 4 91 38 67 50
  • Germany
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Recruiting
        • Universitaetsklinikum Heidelberg ( Site 0401)
        • Contact:
          • Study Coordinator
          • Phone Number: +496221564606
    • Bavaria
      • München, Bavaria, Germany, 81337
        • Recruiting
        • Klinikum der Universität München Großhadern ( Site 0404)
        • Contact:
          • Study Coordinator
          • Phone Number: +4989440072478
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover ( Site 0405)
        • Contact:
          • Study Coordinator
          • Phone Number: +495115329041
  • Israel
      • Petah Tikva, Israel, 4920235
        • Recruiting
        • Schneider Children's Medical Center ( Site 0603)
        • Contact:
          • Study Coordinator
          • Phone Number: 97239376845
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 0601)
        • Contact:
          • Study Coordinator
          • Phone Number: 972353080001
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • University Medical Center Groningen ( Site 0900)
        • Contact:
          • Study Coordinator
          • Phone Number: 31505612800
  • Poland
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 04-730
        • Recruiting
        • Centrum Zdrowia Dziecka w Warszawie-Klinika Kardiologii ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: +48228157370
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-952
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: 48583492870
  • South Africa
    • Gauteng
      • Johannesburg, Soweto, Gauteng, South Africa, 2013
        • Recruiting
        • Wits Clinical Research-Chris Hani Baragwanath Hospital ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: 011 983 6501
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: +34626774330
      • Madrid, Spain, 28007
        • Recruiting
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 915290267
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal ( Site 1300)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 913369027
    • Valencia
      • Valencia, Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: +34699449273
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Recruiting
        • Hacettepe Universite Hastaneleri ( Site 1400)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 (312) 305 50 00
      • Ankara, Turkey (Türkiye), 06560
        • Recruiting
        • Gazi University Health Research and Application Center Gazi -Çocuk Sağlığı ve Hastalıkları Anabilim ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: +903129114848
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi. ( Site 1403)
        • Contact:
          • Study Coordinator
          • Phone Number: +903125529999
      • Istanbul, Turkey (Türkiye), 34303
        • Recruiting
        • Mehmet Akif Ersoy Research and Training Hospital ( Site 1404)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 212 471 80 00
  • United Kingdom
    • London, City of
      • London, London, City of, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 1500)
        • Contact:
          • Study Coordinator
          • Phone Number: 02074059200
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 1606)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-267-7667
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University School of Medicine ( Site 1603)
        • Contact:
          • Study Coordinator
          • Phone Number: 650-497-8000
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Benioff Children's Hospital San Francisco ( Site 1611)
        • Contact:
          • Study Coordinator
          • Phone Number: 415-476-3831
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado ( Site 1609)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-777-6427
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center ( Site 1600)
        • Contact:
          • Study Coordinator
          • Phone Number: 202-476-2130
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: 513-636-7072
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia (CHOP) ( Site 1608)
        • Contact:
          • Study Coordinator
          • Phone Number: 267-426-0120
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Completed
        • Monroe Carell Jr. Children's Hospital ( Site 1601)
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital ( Site 1605)
        • Contact:
          • Study Coordinator
          • Phone Number: 206-987-2000
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Children's Wisconsin ( Site 1610)
        • Contact:
          • Study Coordinator
          • Phone Number: 414-266-2000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Documented, historic diagnostic right heart catheterization (RHC) any time before Screening confirming the diagnosis of PAH WHO Group 1 in any of the following subtypes:
  • Idiopathic pulmonary arterial hypertension (IPAH)
  • Heritable PAH
  • Drug/toxin-induced PAH
  • PAH associated with connective tissue disease
  • PAH-congenital heart disease (CHD) with shunt closure >6 months before Screening and subsequently confirmed by RHC before Screening
  • PAH with coincidental shunt.
  • Must be on a stable dose(s) of background PAH therapy (phosphdiesterase-5 (PDE5) inhibitors, endothelin receptor antagonists (ERAs), soluble guanylate cyclase stimulators (sGCS), or prostanoids [including subcutaneous and intravenous])
  • If male, agree to the following during the intervention period and for at least 16 weeks (112 days) after the last dose of study intervention:
  • Abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent or
  • Uses contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview) as detailed below:
  • Uses a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.
  • If female, must be either not a WOCBP or use a contraceptive method that is highly effective or be abstinent from heterosexual intercourse during the intervention period and for at least 16 weeks (112 days) after the last dose of study intervention
  • If male, agrees to refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study intervention
  • If female, agrees to refrain from 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 intervention

Exclusion Criteria

  • History of left-sided heart disease, including valvular disease (eg, moderate or greater mitral or aortic regurgitation or stenosis), left ventricular outflow tract obstruction, and/or left heart failure (eg, restrictive or dilated cardiomyopathy)
  • Severe (as based on the opinion of the investigator) congenital or developmental abnormalities of the lung, thorax, and/or diaphragm
  • History of Eisenmenger syndrome, Potts shunt, or atrial septostomy
  • Unrepaired or residual cardiac shunt
  • Diagnosis of pulmonary veno-occlusive diseases, pulmonary capillary hemangiomatosis, or overt signs of capillary and/or venous involvement
  • PAH associated with portal hypertension
  • Known visceral (lung, liver, or brain) arteriovenous malformation(s)
  • History of full or partial pneumonectomy
  • Untreated more than mild obstructive sleep apnea
  • History of known pericardial constriction
  • Family history of sudden cardiac death or long QT syndrome
  • Any current or prior history of symptomatic coronary disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months before Screening
  • Cerebrovascular accident within 3 months before Screening
  • Prior exposure to sotatercept or luspatercept or has had an allergic reaction to any of their excipients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Children ≥1 to <18 years old
Participants will receive a subcutaneous (SC) injection every 3 weeks (Q3W) of 0.3 mg/kg. Dosage may be adjusted based on protocol-specific guidelines.
Drug: Sotatercept
SC injection every 3 weeks (Q3W) of 0.3 mg/kg. Dosage may be adjusted based on protocol-specific guidelines.
Other Names:
  • MK-7962

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum Trough Concentration (Ctrough) of Sotatercept
Time Frame: Predose Day 1, Day 21, Day 42, Day 63, Day 84, Day105, Day 126, Day 147, Day 168, Day 189. Postdose Day 7, Day 14, Day 64, Day 69 and Day 76
Ctrough was the lowest concentration of Sotatercept in serum just before the next dose. Blood samples will be collected at multiple time points to estimate the Ctrough of Sotatercept.
Predose Day 1, Day 21, Day 42, Day 63, Day 84, Day105, Day 126, Day 147, Day 168, Day 189. Postdose Day 7, Day 14, Day 64, Day 69 and Day 76
Area Under the Curve at Steady State (AUCss) of Sotatercept
Time Frame: Predose Day 1, Day 21, Day 42, Day 63, Day 84, Day105, Day 126, Day 147, Day 168, Day 189. Postdose Day 7, Day 14, Day 64, Day 69 and Day 76
Blood samples will be collected at multiple time points to estimate the AUCss of Sotatercept.
Predose Day 1, Day 21, Day 42, Day 63, Day 84, Day105, Day 126, Day 147, Day 168, Day 189. Postdose Day 7, Day 14, Day 64, Day 69 and Day 76
Area Under the Curve from 0 to 3 weeks (AUC0-3 weeks) of Sotatercept
Time Frame: Predose Day 1, Day 7, Day 14, and Predose Day 21
Blood samples will be collected at Predose Day 1, Day 7, Day 14, and Predose Day 21 to estimate the AUC0-3 weeks of Sotatercept.
Predose Day 1, Day 7, Day 14, and Predose Day 21
Percentage of Participants Who Experience at Least 1 Adverse Event (AE)
Time Frame: Up to 24 weeks
An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with 1 or more AEs will be assessed.
Up to 24 weeks
Percentage of Participants Who Discontinue Study Drug Due to an AE
Time Frame: Up to 24 weeks
An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants who discontinued the study drug due to an AE regardless of study completion status will be assessed.
Up to 24 weeks
Laboratory Parameter (Hematology): Concentration of Hemoglobin
Time Frame: Up to 24 weeks
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The concentration of hemoglobin will be presented.
Up to 24 weeks
Laboratory Parameter (Hematology): Hematocrit
Time Frame: Up to 24 weeks
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The hematocrit will be presented.
Up to 24 weeks
Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count
Time Frame: Up to 24 weeks
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The RBC count will be presented.
Up to 24 weeks
Laboratory Parameter (Hematology): Reticulocyte Count
Time Frame: Up to 24 weeks
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The reticulocyte count will be presented.
Up to 24 weeks
Laboratory Parameter (Hematology): Platelet Count
Time Frame: Up to 24 weeks
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The platelet count will be presented.
Up to 24 weeks
Blood Pressure (BP)
Time Frame: Up to 24 weeks
BP will be assessed while the participant was seated after a period of rest in a quiet setting with no distractions (eg, television and cell phones).
Up to 24 weeks
Titer of Anti-drug Antibody (ADA) to Sotatercept
Time Frame: Up to 24 weeks
ADA to Sotatercept will be assessed.
Up to 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change from Baseline in 6-Minute Walk Distance (6MWD) (Cohorts 1 and 2)
Time Frame: Baseline and Week 24
6MWD will be assessed using the 6-minute walk test (6MWT).
Baseline and Week 24
Mean Change from Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE)
Time Frame: Baseline and Week 24
A two-dimensional echocardiogram (ECHO) will be performed with the results interpreted by a blinded independent central review (BICR) at baseline and after 24 weeks of treatment. The change from baseline in TAPSE will be reported.
Baseline and Week 24
Mean Change from Baseline in Pulmonary Artery Systolic Pressure (PASP)
Time Frame: Baseline and Week 24
A two-dimensional ECHO will be performed with the results interpreted by a BICR at baseline and after 24 weeks of treatment. The change from baseline in PASP will be reported.
Baseline and Week 24
Mean Change from Baseline in Right Ventricular Fractional Area Change (RVFAC)
Time Frame: Baseline and Week 24
A two-dimensional ECHO will be performed with the results interpreted by a BICR at baseline and after 24 weeks of treatment. The change from baseline in RVFAC will be reported.
Baseline and Week 24
Mean Change from Baseline in Eccentricity Index
Time Frame: Baseline and Week 24
A two-dimensional ECHO will be performed with the results interpreted by a BICR at baseline and after 24 weeks of treatment. The change from baseline in eccentricity index will be reported.
Baseline and Week 24
Mean Change from Baseline in Pediatric Quality of Life (PedsQL) Generic Score
Time Frame: Baseline and Week 24
PedsQL Measurement Model is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The change from baseline in the PedsQL generic core scale will be reported.
Baseline and Week 24
Mean Change from Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP)
Time Frame: Baseline and Week 24
The change from baseline in plasma NT-proBNP levels will be reported.
Baseline and Week 24
Percentage of Participants Who Either Improved or Maintained Their World Health Organization Functional Class (WHO FC)
Time Frame: Baseline and Week 24
The severity of an individual's PAH symptoms will be 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 will be classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC.
Baseline and Week 24
Mean Change from Baseline in Right Ventricular (RV) Function (Cohorts 1 and 2)
Time Frame: Baseline and Week 24
Cardiac magnetic imaging (MRI) will be performed with the results interpreted by a BICR at baseline and after 24 weeks of treatment. The change from baseline in eccentricity index will be reported.
Baseline and Week 24
Mean Change from Baseline on Cardiac Output (Cohorts 1 and 2)
Time Frame: Baseline and Week 24
Cardiac magnetic imaging (MRI) will be performed with the results interpreted by a BICR at baseline and after 24 weeks of treatment. The change from baseline in cardiac output will be reported.
Baseline and Week 24
Mean Change from Baseline in Pulmonary Arterial Pressure (PAP) (Cohorts 1 and 2)
Time Frame: Baseline and Week 24
Cardiac magnetic imaging (MRI) will be performed with the results interpreted by a BICR at baseline and after 24 weeks of treatment. The change from baseline in PAP will be reported.
Baseline and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 21, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7962-008
  • MK-7962-008 (Other Identifier: MSD)
  • 2022-000478-25 (EudraCT Number)
  • U1111-1290-2858 (Registry Identifier: UTN)
  • 2023-504861-22-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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