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Sotatercept in Pulmonary Arterial Hypertension

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. 7 versions Re-verified since Dec 2, 2025, no change to tracked fieldsv4-v10
  2. Primary endpoints: 3 to 6
    • Secondary endpoints: 3 to 6
    • Study description expanded, about 104 words
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 30, 2025 to Oct 6, 2025
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension. Participants will be asked to: * Take Sotatercept every 21 days (±3 days) * Each participant will be enrolled in the study for 29 Weeks * Visit the clinic 18 times * Have a physical exam * Perform assessments of lung function and exercise tests * Have an ultrasound of their heart * Have blood draws done at regular intervals The main objectives of the study are: Primary objective: To assess whether sotatercept will improve recruitment of diffusing membrane capacity (DM) with exercise. Secondary objective: To identify components of the diffusing capacity that respond to treatment with sotatercept in pulmonary arterial hypertension.
Trial Details
NCT Number NCT07140484
Lead Sponsor University of Alberta
Collaborators: Merck Canada Inc., Alberta Health services
Conditions
(from sponsor)		 Pulmonary Artery Hypertension
Related terms Familial Primary Pulmonary Hypertension
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov