NCT06475781 Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD
| NCT ID | NCT06475781 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Foresee Pharmaceuticals Co., Ltd. |
| Condition | Group 3 Pulmonary Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2028-06 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The goal of this clinical trial is to see if mirivadelgat will work in patients 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
Eligibility Criteria
Inclusion Criteria: 1. A clinical diagnosis of PH-ILD. 2. Subject voluntarily gives informed consent. 3. Subjects aged between 18 and 85 years at the time of signing informed consent. 4. Subjects must agree to practice protocol-defined birth control during the study period. * Males with a partner of childbearing potential must practice protocol-defined birth control for the duration of treatment and at least 96 hours after discontinuing the IP. * Female subjects of childbearing of potential (including those \<1-year post menopausal) must practice protocol-defined birth control during the conduct of the study and for 30 days after the last dose of IP (males only during exposure to IP). * Women not of childbearing potential are defined as: 1. Post-menopausal women (at least 12 months with no menses without an alternative medical cause); in women \<45 years of age, a high follicle-stimulating hormone (FSH) level in the post-menopausal range may be used to confirm a post-menopausal state i