Sotatercept in Pulmonary Arterial Hypertension

Recruiting now · Phase 4

Conditions studied: Pulmonary Artery Hypertension

In brief

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.

Key facts

Study ID

NCT07140484

Run by

University of Alberta

People needed

27

Starts

2025-10-06

Expected to finish

2030-01-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 1. Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
• Musculoskeletal limitation that precludes participation in cycle ergometry
• Resting oxygen saturation < 88%. (Note: patients on oxygen can be included in the study if they can maintain a resting saturation of ≥ 88 % after 3 minutes off oxygen).
• Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease.
• Hemoglobin (Hgb) at screening above the gender-specific upper limit of normal (ULN), per local laboratory test.
• Baseline platelet count < 50,000/mm3 (< 50.0 × 109/L) in the enrollment period.
• Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure > 160 mmHg or sitting diastolic blood pressure > 100 mmHg during a screening visit after a period of rest.
• Baseline systolic blood pressure < 90 mmHg at screening.
• Pregnant or breastfeeding women.
• Any of the following clinical laboratory values at the screening visit:
• Estimated glomerular filtration rate (eGFR) < 30 mL/min/m2 (as defined by the Modification of Diet in Renal Disease [MDRD] equation)
• Serum alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels > 3 × ULN (bilirubin criterion waived if there is a documented history of Gilbert's syndrome).
• Currently enrolled in or have completed any other investigational product study within 30 days for small-molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent.
• History of full pneumonectomy.
• Pulmonary function test (PFT) values of forced vital capacity (FVC) < 60% predicted and/or FEV1/FVC < lower limit of normal at the screening visit or within 6 months prior to the screening visit.
• Smoking history of ≥ 20 pack-years or any tobacco smoking or vaping within the previous 3 months.
• Body mass index ≥ 40 kg/m2.
• Planned initiation of an exercise program for cardiopulmonary rehabilitation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible).
• Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C).
• History of restrictive, constrictive, or congestive cardiomyopathy.
• History of atrial septostomy within 180 days prior to the screening visit.
• Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) > 500 ms during the Screening Period
• Personal or family history of long QT syndrome (LQTS) or sudden cardiac death.
• Left ventricular ejection fraction < 45% on historical echocardiogram within 6 months prior to the screening visit.
• Any symptomatic coronary disease events (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months prior to the screening visit. Note: Anginal pain can be ignored as an exclusion criterion if coronary angiography shows no obstructions.

Where it is running

• Clinical Physiology Laboratory — Edmonton, Alberta, Canada (enrolling)

Full record on ClinicalTrials.gov

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