Phase 2 Pulmonary Hypertension Trial, Recruiting
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.
Contact this trial
Principal Investigator: Medical Director, Merck Sharp & Dohme LLC
Phone: 1-888-577-8839
Australian sites
+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
Where this trial is recruiting
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?
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.