A Phase 2 interventional study of Sotatercept and Background PAH Therapy in Pulmonary Arterial Hypertension, sponsored by Merck Sharp & Dohme LLC. Completed at 98 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment
Researchers are looking for other ways to treat people with PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs.
The goal of the study is to learn:
761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's enrollment of 164 is above the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive sotatercept via subcutaneous (SC) injection every 3 weeks at an initial dose of 0.3 mg/kg and then at a maintenance dose of 0.7 mg/kg using a weight-based method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study.
Biological: Sotatercept · Biological: Background PAH Therapy
Participants will receive sotatercept via SC injection every 3 weeks at an initial dose of up to 45 mg and then at a maintenance dose of up to 90 mg using a weight-banded method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study.
Biological: Sotatercept · Biological: Background PAH Therapy
SC administered every 3 weeks.
Also known as: MK-7962
Background PAH therapy may consist of the following drug classes: single, double, or triple combination of therapy with endothelin-receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogs or receptor antagonists
Steady-State Average Serum Concentrations of Sotatercept (Cavg)
Steady-state Cavg of sotatercept will be reported.
Time frame: Predose and at designated time points post-dose (up to 24 weeks)
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is a health problem that happens or worsens during a study. Number of participants who experience an AE will be reported.
Time frame: Up to 37 weeks
Number of Participants who Discontinue Study Treatment due to an Adverse Event
An AE is a health problem that happens or worsens during a study. Number of participants who discontinue study treatment will be reported.
Time frame: Up to 21 weeks
Initial Dose Average Serum Concentrations of Sotatercept (Cavg)
Initial dose Cavg of sotatercept will be reported.
Time frame: Predose and at designated time points post-dose (up to 3 weeks)
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Pulmonary Arterial Hypertension→
Merck Sharp & Dohme LLC