Phase 2 Pulmonary Hypertension Trial, Recruiting NCT05587712 Sponsor: Merck Sharp & Dohme LLC Condition: Pulmonary Hypertension
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Phase 2 Pulmonary Hypertension Trial, Recruiting

NCT05587712
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with pulmonary arterial hypertension (PAH) — high blood pressure in the lungs — confirmed by a past heart procedure called a right heart catheterization, and your PAH falls into one of these specific types: inherited, caused by a drug or toxin, related to a connective tissue disease, related to a congenital heart defect (repaired at least 6 months ago), or of unknown cause.
  • You are currently taking a stable, unchanged dose of approved PAH medication(s), such as a PDE5 inhibitor, endothelin receptor antagonist, sGCS stimulator, or a prostanoid (including injected or under-the-skin types).
  • If you are male, you agree to either abstain from sex with women or use a condom (plus your partner using another method) during the study and for at least 16 weeks after your last dose — and if your partner is pregnant or breastfeeding, you agree to abstain or always use a condom.
  • If you are female, you are either not able to get pregnant, or you agree to use a highly effective form of contraception or abstain from sex during the study and for at least 16 weeks after your last dose.
  • If you are male, you agree not to donate blood or sperm during the study and for at least 16 weeks after your last dose.
  • If you are female, you agree not to donate blood, eggs, or ovum during the study and for at least 16 weeks after your last dose.

Who may not be able to join:

  • You have a history of heart problems on the left side of the heart, such as a faulty heart valve, a blocked outflow from the left side, or left-sided heart failure.
  • You have severe abnormalities of the lungs, chest, or diaphragm that you were born with or developed (confirm with trial site).
  • You have a history of Eisenmenger syndrome, a Potts shunt, or have had a procedure to create an opening between the upper chambers of the heart (atrial septostomy).
  • You have an unrepaired or remaining abnormal connection (hole or shunt) in your heart.
  • You have been diagnosed with certain rare conditions affecting the small blood vessels or veins in the lungs (confirm with trial site).
  • Your PAH is related to high blood pressure in the liver's blood supply (portal hypertension).
  • You have known abnormal blood vessel connections (arteriovenous malformations) in your lungs, liver, or brain.
  • You have had part or all of a lung surgically removed in the past.
  • You have moderate or severe sleep apnea that is not currently being treated.
  • You have a history of stiffening around the heart (pericardial constriction).
  • You or a family member has a history of sudden cardiac death or a heart rhythm condition called long QT syndrome.
  • You have had a heart attack, heart surgery, or chest pain from heart disease within the past 6 months.
  • You have had a stroke within the past 3 months.
  • You have previously taken the drugs sotatercept or luspatercept, or you have had an allergic reaction to any ingredients in those medications.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Medical Director, Merck Sharp & Dohme LLC

Phone: 1-888-577-8839

Australian sites

The Children's Hospital at Westmead ( Site 0001), Westmead, New South Wales
+61298452345

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
19 January 2023
Est. completion
21 September 2028

Where this trial is recruiting

🇦🇺 Australia 🇨🇴 Colombia 🇫🇷 France 🇩🇪 Germany 🇮🇱 Israel 🇳🇱 Netherlands 🇵🇱 Poland 🇿🇦 South Africa 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Serum Trough Concentration (Ctrough) of Sotatercept; Area Under the Curve at Steady State (AUCss) of Sotatercept; Area Under the Curve from 0 to 3 weeks (AUC0-3 weeks) of Sotatercept; Percentage of Participants Who Experience at Least 1 Adverse Event (AE); Percentage of Participants Who Discontinue Study Drug Due to an AE; Laboratory Parameter (Hematology): Concentration of Hemoglobin; Laboratory Parameter (Hematology): Hematocrit; Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count; Laboratory Parameter (Hematology): Reticulocyte Count; Laboratory Parameter (Hematology): Platelet Co...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov