Sotatercept in Pulmonary Arterial Hypertension

NCT07140484 | Recruiting Phase 4 FDA Drug

• 1 other identifier: Pro00148970
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Artery Hypertension

Keywords

diffusing capacity; membrane diffusing capacity; pulmonary capillary blood volume

Outcome Measures

Primary Outcomes (6)

• Lung diffusing capacity

  Lung diffusing capacity (DLCO) will be measured using six-second, advanced DLCO techniques

  6 weeks post starting treatment

• Lung diffusing capacity

  Lung diffusing capacity (DLCO) will be measured using six-second, advanced DLCO techniques

  23 weeks post starting treatment

• Diffusing membrane capacity (Dm)

  Diffusing membrane capacity will be measured using six-second, advanced DLCO

  6 weeks post starting treatment

• Diffusing membrane capacity (Dm)

  Diffusing membrane capacity will be measured using six-second, advanced DLCO

  23 weeks post starting treatment

• Pulmonary capillary blood volume (Vc)

  Pulmonary capillary blood volume (Vc) will be measured using six-second, advanced DLCO techniques

  6 weeks post starting treatment

• Pulmonary capillary blood volume (Vc)

  Pulmonary capillary blood volume (Vc) will be measured using six-second, advanced DLCO techniques

  23 weeks post starting treatment

Secondary Outcomes (6)

• Cardiac structure and function

  6 weeks post starting treatment

• Cardiac structure and function

  23 weeks post starting treatment

• Cardiac function

  6 weeks post starting treatment

• Cardiac function

  23 weeks post starting treatment

• Peripheral muscle microcirculation

  6 weeks post starting treatment

Study Arms (1)

Sotatercept Group

EXPERIMENTAL

Sotatercept 0.7mg/kg

Drug: Sotatercept

Interventions

Sotatercept DRUG

0.7mg/kg

Also known as: Winrevair

Sotatercept Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of PAH Group 1 in any of the following subtypes:
• Idiopathic PAH
• Heritable PAH
• Drug/toxin-induced PAH
• PAH associated with CTD
• PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair.
• Symptomatic PAH classified as WHO FC II or III.
• On stable doses of ≥2 background PAH therapies for at least 60 days prior to screening; for infusion prostacyclins, dose adjustment within 10% of the optimal dose is allowed per medical practice. Patients on 1 background PAH therapy are eligible if there is documented intolerance or contraindication to use of the other 2 classes (e.g. liver enzyme elevation while taking an ERA).
• Females of childbearing potential must:
• Have a negative urine or serum pregnancy tests as verified by the investigator prior to starting study therapy.
• If sexually active, have used, and agree to use highly effective contraception without interruption during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study treatment.
• Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study treatment.
• Male participants must:
• Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Merck Canada Inc.: collaborator
• Alberta Health services: collaborator
• University of Alberta: lead

Study Sites (1)

Clinical Physiology Laboratory

Edmonton, Alberta, T6G2R3, Canada

RECRUITING

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension

Interventions

ACE-011

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jason Weatherald, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Michael Stickland, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Desi Fuhr, MSc

CONTACT

7804921121; fuhr@ualberta.ca

Kostia Dmytriiev, MD

CONTACT

7804928027; kdmytrii@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 24, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)