RecruitingPhase 2NCT06475781

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

A Multinational Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of Mirivadelgat, an Aldehyde Dehydrogenase 2 Activator, in Patients With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)


Sponsor

Foresee Pharmaceuticals Co., Ltd.

Enrollment

126 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called mirivadelgat in people who have pulmonary hypertension associated with interstitial lung disease (PH-ILD). This is a serious condition where high blood pressure develops in the lungs because of underlying scarring or inflammation of lung tissue. The drug targets a specific pathway to try to reduce pressure in the lungs and improve the ability to walk and breathe. **You may be eligible if...** - You are between 18 and 85 years old - You have been diagnosed with PH-ILD (confirmed by right heart catheterization and lung imaging) - You can walk between 100 and 500 meters in 6 minutes - Your lung function is reduced but not severely (specific FVC and DLCO thresholds) - You have been on stable treatment for your underlying lung disease for at least 30 days **You may NOT be eligible if...** - You have other types of pulmonary hypertension unrelated to lung disease - You have significant heart disease (weak heart, valve disease, or recent heart problems) - You are on other pulmonary hypertension-approved drugs (except inhaled treprostinil) - You have chronic kidney disease Stage IV or worse - You have used tobacco or marijuana within the last 6 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMirivadelgat

Selective aldehyde dehydrogenase 2 (ALDH2) activator

DRUGplacebo

placebo


Locations(9)

Hualien Tzu Chi Hospital

Hualien City, Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

MacKay Memorial Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital - Linkou Branch

Taoyuan City, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06475781