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Pulmonary Arterial HypertensionPhase 2MOONBEAMNCT05587712

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

A Phase 2 study testing Sotatercept in people with Pulmonary Arterial Hypertension, run by Merck Sharp & Dohme LLC at 35 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 1 year to 17 years
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
42 participants
Where
35 sitesin 12 countries
Study dates
19 Jan 2023to 21 Sep 2028
Phase
Phase 2
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 1 year to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

35 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

35 sites in 12 countries

United States10 sites, 9 recruiting

  • Children's Hospital Colorado ( Site 1609)

    Aurora, Colorado, 80045

    Study Coordinator, 720-777-6427

    Recruiting

  • Cincinnati Children's Hospital Medical Center ( Site 1602)

    Cincinnati, Ohio, 45229

    Study Coordinator, 513-636-7072

    Recruiting

  • The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 1606)

    Los Angeles, California, 90095

    Study Coordinator, 310-267-7667

    Recruiting

  • Children's Wisconsin ( Site 1610)

    Milwaukee, Wisconsin, 53226

    Study Coordinator, 414-266-2000

    Recruiting

  • Monroe Carell Jr. Children's Hospital ( Site 1601)

    Nashville, Tennessee, 37232

    Completed

  • Stanford University School of Medicine ( Site 1603)

    Palo Alto, California, 94304

    Study Coordinator, 650-497-8000

    Recruiting

  • Children's Hospital of Philadelphia (CHOP) ( Site 1608)

    Philadelphia, Pennsylvania, 19104

    Study Coordinator, 267-426-0120

    Recruiting

  • UCSF Benioff Children's Hospital San Francisco ( Site 1611)

    San Francisco, California, 94158

    Study Coordinator, 415-476-3831

    Recruiting

  • Seattle Children's Hospital ( Site 1605)

    Seattle, Washington, 98105

    Study Coordinator, 206-987-2000

    Recruiting

  • Children's National Medical Center ( Site 1600)

    Washington D.C., District of Columbia, 20010

    Study Coordinator, 202-476-2130

    Recruiting

Other trials in United States

Spain4 sites, 4 recruiting

  • Hospital Universitari Vall d'Hebron ( Site 1302)

    Barcelona, 08035

    Study Coordinator, +34626774330

    Recruiting

  • Hospital Universitario Ramón y Cajal ( Site 1300)

    Madrid, Madrid, Comunidad de, 28034

    Study Coordinator, +34 913369027

    Recruiting

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1301)

    Madrid, 28007

    Study Coordinator, +34 915290267

    Recruiting

  • Hospital Universitari i Politecnic La Fe ( Site 1303)

    Valencia, Valencia, 46026

    Study Coordinator, +34699449273

    Recruiting

Other trials in Spain

Turkey (Türkiye)4 sites, 4 recruiting

  • Hacettepe Universite Hastaneleri ( Site 1400)

    Ankara, 06100

    Study Coordinator, +90 (312) 305 50 00

    Recruiting

  • Gazi University Health Research and Application Center Gazi -Çocuk Sağlığı ve Hastalıkları Anabilim ( Site 1402)

    Ankara, 06560

    Study Coordinator, +903129114848

    Recruiting

  • Ankara Bilkent Şehir Hastanesi. ( Site 1403)

    Ankara, 06800

    Study Coordinator, +903125529999

    Recruiting

  • Mehmet Akif Ersoy Research and Training Hospital ( Site 1404)

    Istanbul, 34303

    Study Coordinator, +90 212 471 80 00

    Recruiting

Other trials in Turkey (Türkiye)

Colombia3 sites, 3 recruiting

  • Fundación Valle del Lili ( Site 0200)

    Cali, Valle del Cauca Department, 760032

    Study Coordinator, +576023319090

    Recruiting

  • Clínica Imbanaco S.A.S ( Site 0203)

    Cali, Valle del Cauca Department, 760042

    Study Coordinator, +576023851000

    Recruiting

  • Clinica Somer-Unidad de Investigacion y Docencia ( Site 0205)

    Rionegro, Antioquia, 054040

    Study Coordinator, +573003358838

    Recruiting

Other trials in Colombia

France3 sites, 3 recruiting

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 0303)

    Marseille, Provence-Alpes-Côte d'Azur Region, 13005

    Study Coordinator, +33 4 91 38 67 50

    Recruiting

  • Hôpital Universitaire Necker Enfants Malades ( Site 0300)

    Paris, 75015

    Study Coordinator, +33 1 71 39 66 22

    Recruiting

  • CHU de Toulouse - Hôpital des Enfants ( Site 0302)

    Toulouse, Haute-Garonne, 31059

    Study Coordinator, +33534558597

    Recruiting

Other trials in France

Germany3 sites, 3 recruiting

  • Medizinische Hochschule Hannover ( Site 0405)

    Hanover, Lower Saxony, 30625

    Study Coordinator, +495115329041

    Recruiting

  • Universitaetsklinikum Heidelberg ( Site 0401)

    Heidelberg, Baden-Wurttemberg, 69120

    Study Coordinator, +496221564606

    Recruiting

  • Klinikum der Universität München Großhadern ( Site 0404)

    München, Bavaria, 81337

    Study Coordinator, +4989440072478

    Recruiting

Other trials in Germany

Israel2 sites, 2 recruiting

  • Schneider Children's Medical Center ( Site 0603)

    Petah Tikva, 4920235

    Study Coordinator, 97239376845

    Recruiting

  • Sheba Medical Center ( Site 0601)

    Ramat Gan, 5265601

    Study Coordinator, 972353080001

    Recruiting

Other trials in Israel

Poland2 sites, 2 recruiting

  • Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 1102)

    Gdansk, Pomeranian Voivodeship, 80-952

    Study Coordinator, 48583492870

    Recruiting

  • Centrum Zdrowia Dziecka w Warszawie-Klinika Kardiologii ( Site 1103)

    Warsaw, Masovian Voivodeship, 04-730

    Study Coordinator, +48228157370

    Recruiting

Other trials in Poland

Australia1 site, 1 recruiting

  • The Children's Hospital at Westmead ( Site 0001)

    Westmead, New South Wales, 2145

    Study Coordinator, +61298452345

    Recruiting

Other trials in Australia

Netherlands1 site, 1 recruiting

  • University Medical Center Groningen ( Site 0900)

    Groningen, 9713 GZ

    Study Coordinator, 31505612800

    Recruiting

Other trials in Netherlands

South Africa1 site, 1 recruiting

  • Wits Clinical Research-Chris Hani Baragwanath Hospital ( Site 1201)

    Johannesburg, Soweto, Gauteng, 2013

    Study Coordinator, 011 983 6501

    Recruiting

Other trials in South Africa

United Kingdom1 site, 1 recruiting

  • Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 1500)

    London, London, City of, WC1N 3JH

    Study Coordinator, 02074059200

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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.

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.

  • SotaterceptDrug

    Also called MK-7962

    SC injection every 3 weeks (Q3W) of 0.3 mg/kg. Dosage may be adjusted based on protocol-specific guidelines.

Study groups in NCT05587712
Study groupRoleWhat they receive
Children ≥1 to <18 years oldExperimentalParticipants will receive a subcutaneous (SC) injection every 3 weeks (Q3W) of 0.3 mg/kg. Dosage may be adjusted based on protocol-specific guidelines.
Receives: Drug: Sotatercept

What is being measured

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

  1. Serum Trough Concentration (Ctrough) of Sotatercept

    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.

    Measured: 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

  2. Area Under the Curve at Steady State (AUCss) of Sotatercept

    Blood samples will be collected at multiple time points to estimate the AUCss of Sotatercept.

    Measured: 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

  3. Area Under the Curve from 0 to 3 weeks (AUC0-3 weeks) of Sotatercept

    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.

    Measured: Predose Day 1, Day 7, Day 14, and Predose Day 21

  4. Percentage of Participants Who Experience at Least 1 Adverse Event (AE)

    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.

    Measured: Up to 24 weeks

  5. Percentage of Participants Who Discontinue Study Drug Due to an AE

    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.

    Measured: Up to 24 weeks

  6. Laboratory Parameter (Hematology): Concentration of Hemoglobin

    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.

    Measured: Up to 24 weeks

  7. Laboratory Parameter (Hematology): Hematocrit

    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.

    Measured: Up to 24 weeks

  8. Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count

    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.

    Measured: Up to 24 weeks

  9. Laboratory Parameter (Hematology): Reticulocyte Count

    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.

    Measured: Up to 24 weeks

  10. Laboratory Parameter (Hematology): Platelet Count

    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.

    Measured: Up to 24 weeks

  11. Blood Pressure (BP)

    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).

    Measured: Up to 24 weeks

  12. Titer of Anti-drug Antibody (ADA) to Sotatercept

    ADA to Sotatercept will be assessed.

    Measured: Up to 24 weeks

Secondary outcomes (11)

  1. Mean Change from Baseline in 6-Minute Walk Distance (6MWD) (Cohorts 1 and 2)

    6MWD will be assessed using the 6-minute walk test (6MWT).

    Measured: Baseline and Week 24

  2. Mean Change from Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE)

    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.

    Measured: Baseline and Week 24

  3. Mean Change from Baseline in Pulmonary Artery Systolic Pressure (PASP)

    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.

    Measured: Baseline and Week 24

  4. Mean Change from Baseline in Right Ventricular Fractional Area Change (RVFAC)

    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.

    Measured: Baseline and Week 24

  5. Mean Change from Baseline in Eccentricity Index

    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.

    Measured: Baseline and Week 24

  6. Mean Change from Baseline in Right Ventricular (RV) Function (Cohorts 1 and 2)

    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.

    Measured: Baseline and Week 24

  7. Mean Change from Baseline on Cardiac Output (Cohorts 1 and 2)

    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.

    Measured: Baseline and Week 24

  8. Mean Change from Baseline in Pulmonary Arterial Pressure (PAP) (Cohorts 1 and 2)

    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.

    Measured: Baseline and Week 24

  9. Mean Change from Baseline in Pediatric Quality of Life (PedsQL) Generic Score

    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.

    Measured: Baseline and Week 24

  10. Mean Change from Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP)

    The change from baseline in plasma NT-proBNP levels will be reported.

    Measured: Baseline and Week 24

  11. Percentage of Participants Who Either Improved or Maintained Their World Health Organization Functional Class (WHO FC)

    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.

    Measured: Baseline and Week 24

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 2022
  2. Study start19 Jan 2023
  3. Primary completion21 Sep 2028 (estimated)
  4. Study completion21 Sep 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05587712
Sponsor's protocol ID
7962-008
Other IDs
MK-7962-008, 2023-504861-22-00, U1111-1290-2858, 2022-000478-25, 2023
Acronym
MOONBEAM
Status last verified
Oct 2026
First submitted
17 Oct 2022
Last updated
2 Nov 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sotatercept in people with Pulmonary Arterial Hypertension, run by Merck Sharp & Dohme LLC at 35 sites in 12 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 15 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Spain, Turkey (Türkiye), Colombia, France and 7 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 12 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 NCT05587712.

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 2 Nov 2026.

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