Clinical Trial

Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD (Windward)

Study acronym: WINDWARD
Recruiting Phase 2
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Summary
The goal of this clinical trial is to see if mirivadelgat will work in participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD). It will also learn about the safety of mirivadelgat. The main question it aims to answer is if mirivadelgat will improve pulmonary vascular resistance (PVR). Pulmonary vascular resistance is a way to measure blood flow in the lungs. Researchers will compare mirivadelgat to a placebo (a look-alike capsule that contains no drug) to see if mirivadelgat works to improve the symptoms of PH-ILD. The symptoms of PH-ILD that are being looked at are exercise tolerance, heart function, and general well-being. Participants will: Take mirivadelgat or a placebo once a day for 12 weeks Visit the clinic once every 4 weeks for checkups and tests Receive phone calls every one or two weeks to check on how things are going
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2024-06-19; most recent amendment 2026-07-20.
Status change: Not Yet Recruiting → Recruiting 2025-03-04
Trial Details
NCT Number NCT06475781
Lead Sponsor Foresee Pharmaceuticals Co., Ltd.
Collaborators: QPS Holdings LLC
Conditions Group 3 Pulmonary Hypertension
Enrollment 126 participants
Start Date 2025-03-01
Primary Completion 2028-02 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-11