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Sotatercept for Children with Pulmonary Arterial Hypertension

This study is testing a drug called sotatercept (MK-7962) in children aged 1 to 17 years who have pulmonary arterial hypertension (PAH). PAH is a serious condition where blood pressure in the arteries leading to the lungs is too high. The main goals are to see how safe sotatercept is, how well children tolerate it, and how the body processes the drug over 24 weeks. Researchers will be looking at levels of sotatercept in the blood. The study plans to enroll 42 participants. The current recruitment status is unclear. To join, you must have a confirmed diagnosis of PAH, including specific types like Idiopathic PAH or PAH linked to connective tissue disease.

Study design
This is an interventional study with a planned enrollment of 42 participants. The phase of the study is not specified.
What's involved
Participants will receive sotatercept as an injection under the skin every 3 weeks for 24 weeks. Blood samples will be taken at various times throughout the study to measure drug levels.
Compensation
Not stated in the trial record.
Follow-up
Blood samples for drug levels are measured up to Day 189 (approximately 27 weeks) and then at Day 64, Day 69, and Day 76 after the last dose.

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NCT05587712

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

Recruiting
PHASE2Ages 1–17InterventionalTreatment
Merck Sharp & Dohme LLC
~42 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:Sotatercept

At a glance

Recruiting sites
34 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Serum Trough Concentration (Ctrough) of Sotatercept
Measured over 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
+11 more outcomes measured

Conditions

Pulmonary Arterial Hypertension

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Where you'd take part

This study runs at 35 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ankara Bilkent Şehir Hastanesi. ( Site 1403)

    Ankara, Turkey (Türkiye)study coordinator listed

    Recruiting

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

    Marseille, Provence-Alpes-Côte d'Azur Region, Francestudy coordinator listed

    Recruiting

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

    Warsaw, Masovian Voivodeship, Polandstudy coordinator listed

    Recruiting

  • Children's Hospital Colorado ( Site 1609)

    Aurora, Coloradostudy coordinator listed

    Recruiting

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

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • Children's National Medical Center ( Site 1600)

    Washington D.C., District of Columbiastudy coordinator listed

    Recruiting

  • Children's Wisconsin ( Site 1610)

    Milwaukee, Wisconsinstudy coordinator listed

    Recruiting

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

    Toulouse, Haute-Garonne, Francestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Serum Trough Concentration (Ctrough) of SotaterceptPredose 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.

  • Area Under the Curve at Steady State (AUCss) of SotaterceptPredose 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.

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

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

  • Percentage of Participants Who Discontinue Study Drug Due to an AEUp 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.

  • Laboratory Parameter (Hematology): Concentration of HemoglobinUp 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.

  • Laboratory Parameter (Hematology): HematocritUp 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.

  • Laboratory Parameter (Hematology): Red Blood Cell (RBC) CountUp 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.

  • Laboratory Parameter (Hematology): Reticulocyte CountUp 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.

  • Laboratory Parameter (Hematology): Platelet CountUp 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.

  • Blood Pressure (BP)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).

  • Titer of Anti-drug Antibody (ADA) to SotaterceptUp to 24 weeks

    ADA to Sotatercept will be assessed.