Study to Evaluate Safety and Efficacy of Mirivadelgat in PH-ILD
ConditionGroup 3 Pulmonary Hypertension
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorForesee Pharmaceuticals Co., Ltd.
About this trial
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
Qualifiers
A clinical diagnosis of PH-ILD.
Subject voluntarily gives informed consent.
Subjects aged between 18 and 85 years at the time of signing informed consent.
Subjects must agree to practice protocol-defined birth control during the study period.
Disqualifiers
Subject has another concomitant diagnosis of pulmonary hypertension not otherwise considered to be PH-ILD. This would include and is not limited to the concomitant presence of thromboembolic disease, untreated/inadequately treated obstructive sleep apnea, human immunodeficiency virus (HIV), methamphetamine or anorexigenic drug use, and other conditions of the WHO Group 1, 2, 4, and 5 classifications.
Left ventricular ejection fraction <40% as assessed by echocardiography.
More than mild left-sided valvulopathy (e.g., worse than mild mitral stenosis or regurgitation and worse than mild aortic stenosis or regurgitation).
LVEDP or PCWP >15 mmHg (or >12 mmHg if PVR ≥4 to 6.25 Wood units).
Trial design
Treatments tested in this trial
- Mirivadelgat
- placebo
Treatment groups
126 Participants
are divided into 3 treatment groupsSponsors and collaborators
Foresee Pharmaceuticals Co., Ltd.
Lead sponsor
QPS-Qualitix Clinical Research Co., Ltd
Collaborator
Source ClinicalTrials.gov