Actively Recruiting
Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD
Led by Foresee Pharmaceuticals Co., Ltd. · Updated on 2025-10-06
126
Participants Needed
9
Research Sites
178 weeks
Total Duration
On this page
Sponsors
F
Foresee Pharmaceuticals Co., Ltd.
Lead Sponsor
Q
QPS-Qualitix Clinical Research Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of pulmonary hypertension associated with interstitial lung disease (PH-ILD)
- Age between 18 and 85 years at informed consent
- Willingness to give informed consent
- Agreement to use protocol-defined birth control during the study
- Confirmed diagnosis of interstitial lung disease by HRCT or biopsy within 180 days prior to screening or at screening
- Right heart catheterization (RHC) during screening with pulmonary vascular resistance \u22654 Wood units and mean pulmonary arterial pressure >20 mmHg
- Pulmonary capillary wedge pressure (PCWP) \u226412 mmHg if PVR <6.25 Wood units or PCWP \u226415 mmHg if PVR \u22656.25 Wood units
- Baseline 6-minute walk distance between 100 and 500 meters
- Agreement to repeat RHC, chest CT, and MRI before study completion
- Stable/optimized chronic treatment for underlying lung disease for at least 30 days prior to screening and treatment for at least 90 days
- Stable supportive medication doses for at least 30 days prior to screening
- Ability to consent and communicate with local staff and attend all study visits
- Clinical laboratory values within normal limits or <1.5 times upper limit of normal
- Pulmonary function test showing forced vital capacity (FVC) <70% predicted and diffusion capacity of carbon monoxide (DLCO) <70% corrected for hemoglobin, with DLCO between 25% and 90%
- Up to 20% of subjects may have connective tissue diseases such as systemic sclerosis, lupus, Sjogren's, polymyositis/dermatomyositis/antisynthetase syndrome, or rheumatoid arthritis
- Negative hepatitis B surface antigen and hepatitis C antibody tests at screening
You will not qualify if you...
- Diagnosis of pulmonary hypertension other than PH-ILD, including thromboembolic disease, untreated sleep apnea, HIV, drug use, or other WHO Group 1, 2, 4, or 5 conditions
- Clinically significant left-sided heart disease within 6 months, including left ventricular ejection fraction <40% or more than mild valvulopathy
- Pulmonary capillary wedge pressure or left ventricular end diastolic pressure >15 mmHg (or >12 mmHg if PVR 4 to 6.25 Wood units)
- Having three or more risk factors for left ventricular disease/dysfunction such as BMI ≥30 kg/m2, uncontrolled diabetes, or recent significant coronary disease
- Receiving oxygen supplementation >10 L/min at rest
- Recent use of PH-approved therapies within 60 days (except stable inhaled prostacyclin)
- Use of potent CYP3A4 inhibitors or inducers
- Recent exacerbation of lung disease or active respiratory infection within 4 weeks
- Active malignancy or recent history likely to affect survival or require major treatment
- Chronic kidney disease stage IV or greater or acute kidney injury
- History of congenital heart disease
- Use of tobacco, nicotine, marijuana, or substance abuse within 6 months
- Recent acute pulmonary embolism or pulmonary rehabilitation
- Recent participation in investigational drug/device study within 30 days
- BMI ≥40 kg/m2
- Uncontrolled hypertension during screening
- Life expectancy less than 6 months
- Unable to participate fully or comply with study procedures
- High likelihood of lung transplant within 4 months
- History of liver dysfunction or coagulation disorders
- Pregnancy or breastfeeding
- Untreated sleep apnea worse than mild
- Allergic reaction to mirivadelgat or its excipients
- Previous exposure to mirivadelgat
- Laboratory abnormalities including low hemoglobin, white blood cells, platelets, or low kidney function
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Hualien Tzu Chi Hospital
Hualien City, Taiwan, 970
Actively Recruiting
2
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan, 813
Actively Recruiting
3
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
4
Taichung Veterans General Hospital
Taichung, Taiwan, 407219
Actively Recruiting
5
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
6
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
7
MacKay Memorial Hospital
Taipei, Taiwan, 104
Actively Recruiting
8
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
9
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan City, Taiwan
Actively Recruiting
Research Team
B
Bassem Elmankabadi, MD
CONTACT
Y
Yisheng Lee, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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