A Phase 4 interventional study of Sotatercept in Hypertension, Pulmonary, sponsored by Merck Sharp & Dohme LLC. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 4, Interventional, and Treatment
Researchers are looking for ways to treat people with a type of high blood pressure in the lungs called pulmonary arterial hypertension (PAH). This study focuses on Chinese participants who are already taking stable, standard-of-care medications for their PAH. Researchers want to know if adding the study treatment, sotatercept, to their current background treatment can help treat people with PAH.
Participants in this study will start a new treatment regimen where they will receive sotatercept as an add-on therapy, and researchers will monitor their health.
The main goals of this study are to learn if sotatercept is safe, if participants tolerate it well, and how effective it is at improving their exercise capacity and physical health when added to their ongoing PAH treatment.
1,091 studies on the registry are indexed under Hypertension, Pulmonary; 243 are open to participants now.
This study's planned enrollment of 40 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 502 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sotatercept will be administered subcutaneous (SC) starting at a dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks (Q3W) plus background Pulmonary Arterial Hypertension (PAH) therapy.
Biological: Sotatercept
subcutaneous injection
Also known as: ACE-011
Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 24.
The 6MWD is a clinical test that measures the distance, in meters, that a participant can walk on a flat, hard surface in a period of 6 minutes. This test evaluates the participant's integrated response to exercise (functional capacity). An increase in the distance walked represents an improvement in functional exercise capacity. The change from baseline is calculated by subtracting the baseline distance from the Week 24 distance.
Time frame: Baseline and Week 24
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Time frame: Up to approximately 37 weeks.
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to approximately 21 weeks.
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24
PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC). The change from baseline in PVR at Week 24 will be presented.
Time frame: Baseline and Week 24
Percentage of Participants with Improvement in World Health Organization (WHO) Functional Class (FC) at Week 24
The WHO FC is a 4-category scale (Class I, II, III, or IV) that assesses the severity of a participant's disease based on symptoms and physical limitations. A lower class indicates less severe disease. Improvement is defined as a decrease of at least one functional class from Baseline to Week 24. Maintenance of WHO FC II is defined as remaining in WHO FC II from Baseline to Week 24. The percentage of participants who demonstrate improvement or maintenance of WHO FC II at Week 24 will be reported.
Time frame: Baseline and Week 24
Change from Baseline in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) at Week 24
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. NT-proBNP will be measured at baseline and at Week 24. The change from baseline in NT-proBNP at Week 24 will be presented.
Time frame: Baseline and Week 24
No study locations are listed for this record.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Start is estimated for Nov 2026; primary completion for Mar 2028, 15 months later.
Of 23 phase 4 interventional studies under Hypertension, Pulmonary, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 54. This study's planned 15 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sotatercept