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Looking for participantsPhase2

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

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT05587712

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sotatercept (drug)
How long the study runs
Study runs about 68 months (dates as stated)
About the drug or intervention
Sotatercept — drug: SC injection every 3 weeks (Q3W) of 0.3 mg/kg.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at a medicine called sotatercept in children with pulmonary arterial hypertension (PAH), a condition where the blood pressure in the arteries of the lungs is too high. It is run by Merck Sharp & Dohme LLC. The trial is testing how well the medicine works in children whose PAH has been confirmed by a heart test called right heart catheterisation.

Who can take part

  • Has pulmonary arterial hypertension (PAH) confirmed by a right heart catheterisation (a heart test) at any time before screening
  • Has one of these types of PAH: PAH with no known cause, inherited PAH, PAH caused by a drug or toxin, PAH linked to connective tissue disease, PAH linked to congenital heart disease (a heart problem from birth) that has been repaired, or PAH with a heart hole found by chance
  • Already taking a steady dose of PAH medicine, such as phosphodiesterase-5 (PDE5) inhibitors, endothelin receptor antagonists, soluble guanylate cyclase stimulators, or prostanoids (given under the skin or into a vein)
  • Boys must use a condom or avoid sex during the study and for at least 16 weeks after the last dose, and must not donate blood or sperm during this time
  • Girls who could become pregnant must use highly effective contraception or avoid sex during the study and for at least 16 weeks after the last dose, and must not donate blood or eggs during this time

Who may not be able to

  • Past left-sided heart disease, such as heart valve disease or heart failure
  • Severe lung, chest, or diaphragm problems present from birth or childhood (based on the study doctor's opinion)
  • History of Eisenmenger syndrome, a Potts shunt, or an atrial septostomy (heart or lung procedures or conditions)
  • A heart hole that has not been repaired or is still leaking
  • Pulmonary veno-occlusive disease, pulmonary capillary haemangiomatosis, or signs of problems with small lung blood vessels
  • PAH linked to portal hypertension (high blood pressure in the liver)
  • Known abnormal connections between arteries and veins in the lung, liver, or brain
  • Past surgery to remove part or all of a lung
  • Untreated sleep apnoea (pauses in breathing during sleep) that is more than mild
  • Known tightening of the sac around the heart
  • Family history of sudden cardiac death or long QT syndrome (a heart rhythm problem)
  • Heart disease symptoms such as a heart attack, heart procedure, or chest pain caused by the heart within 6 months before screening
  • A stroke within 3 months before screening
  • Has taken sotatercept or luspatercept before, or has had an allergic reaction to any of their ingredients

What taking part involves

  • • Taking the study medicine sotatercept (MK-7962) alongside your existing PAH medicines
  • • Not stated — ask the trial team about how the medicine is given, how often, and for how long

Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and exactly what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
1 Year to 17 Years
Who
All
Number of participants
42
Started
2023-01-19
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for pulmonary arterial hypertension
  • • Phase2 - 42 participants
  • • 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)

Who can take part?

  • • Ages 1 Year to 17 Years
  • • Diagnosed with pulmonary arterial hypertension

Where?

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

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Pulmonary Arterial Hypertension

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 1 Year - 17 Years
  • Who can join: All genders

What the study is looking for

  • ✓Inclusion Criteria
  • ✓Documented, historic diagnostic right heart catheterization (RHC) any time before Screening confirming the diagnosis...
  • ✓Idiopathic lung arterial hypertension (IPAH)
  • ✓Heritable PAH
  • ✓Drug/toxin-induced PAH
See the full criteria
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

Where Is This Study? (1 UK site)

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

London WC1N 3JH, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator02074059200

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-04