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Group 3 Pulmonary HypertensionPhase 2WINDWARDNCT06475781

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

A Phase 2 study testing Mirivadelgat in people with Group 3 Pulmonary Hypertension, run by Foresee Pharmaceuticals Co., Ltd. at 11 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Group 3 Pulmonary Hypertension
What is being tested?
Mirivadelgat
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
11 sitesin 2 countries
Study dates
1 Mar 2025to Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A clinical diagnosis of PH-ILD.
  • Participant voluntarily gives informed consent.
  • Male or female participants aged between 18 and 85 years at the time of signing informed consent.
  • Participants must agree to practice protocol-defined birth control during the study period, unless they meet criteria for not being of childbearing potential.
  • Male participants with female partners of childbearing potential must practice protocol- defined birth control for the duration of treatment and at least 96 hours after discontinuing the IP.
  • Female participants 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).
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  • Female participants not of childbearing potential (as defined below) are eligible for enrolment without contraception requirements:
  • 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 in women not using hormonal contraception or hormonal replacement therapy; OR
  • Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening; OR
  • Have a congenital or acquired condition that prevents childbearing.
  • The participant has a confirmed diagnosis of any form of interstitial lung disease based on high-resolution computed tomography (HRCT) of the chest within 180 days prior to screening or at screening or a historical surgical biopsy (or other appropriate tissue sampling (e.g., cryobiopsy). The participant can have other findings (e.g., emphysema) if this is not the predominant feature on the scan.
  • Participants have undergone RHC during the screening period with the following documented parameters:
  • Pulmonary vascular resistance (PVR) ≥4 Wood units and
  • Pulmonary capillary wedge pressure (PCWP) of ≤12 mmHg [if PVR ≥4 Wood units to <6.25 Wood units] or PCWP ≤15 mmHg [if PVR ≥6.25 Wood units] Note: If a reliable PCWP cannot be obtained, left ventricular end-diastolic pressure (LVEDP), measured via left heart catheterization (LHC), will be acceptable, with the same numerical thresholds as the PCWP criterion: LVEDP of ≤12 mmHg [if PVR ≥4 to <6.25 Wood units], or LVEDP ≤15 mmHg
  • A mean pulmonary arterial pressure (PAP) of >20 mmHg.
  • Participants must have a 6-minute walk distance ≥100 meters and ≤500 meters at the Screening Visit (Visit 1).
  • Participants agree to a repeat RHC, Chest CT, and MRI prior to study completion.
  • Participants on chronic treatment for underlying lung disease (i.e., nintedanib or pirfenidone or immunosuppressive agents etc.) must be on a stable/optimized dose for ≥30 days prior to screening and have been receiving treatment for ≥90 days.
  • Participants on supportive medications (e.g., inhalers for asthma) must be on stable doses for ≥30 days prior to screening.
  • In the Investigator's opinion, the participant must be able to consent for themselves and communicate with local staff using interpreters if necessary. Participants must agree to attend all study visits and be contactable through a cellular device or landline.
  • Participants must have clinical laboratory values within normal ranges or <1.5 times the upper limit of normal (ULN) as specified by the testing laboratory.
  • Participants must meet the following requirements for the pulmonary function test (PFT) at screening:
  • Forced vital capacity (FVC) <90% of predicted
  • Diffusion capacity of carbon monoxide (DLCO) <70% of predicted, or <70% of predicted corrected for hemoglobin (Hb), if correction is required. (Correction applies if Hb value is ≥25% and ≤90% of normal.) Note: DLCO must be determined locally at screening, using American Thoracic Society (ATS) standards. Hemoglobin correction should reference ATS normal values: Men = 14.6 g/dL, Women = 13.4 g/dL.
  • Negative serology test for hepatitis B surface antigen and hepatitis C antibody at Screening Visit.

Who cannot join

  • Medical Conditions
  • Participant 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.
  • Participant has evidence of clinically significant left-sided heart disease within 6 months of screening as defined by:
  • 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).
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  • Participants must NOT have 3 or more of the following left ventricular disease/dysfunction risk factors at screening:
  • Body mass index (BMI) ≥30 kg/m2.
  • Uncontrolled diabetes, as evidenced by HbA1C >9.5%, or urine glycosuria >1.0 g/dl, or presence of diabetic ketoacidosis.
  • History of significant coronary disease within 6 months of screening as demonstrated by any of the following:
  • History of myocardial infarction or acute coronary syndrome (unstable angina), or
  • Percutaneous coronary intervention or percutaneous transluminal angioplasty, or previous coronary artery bypass graft, or
  • Evidence of coronary artery disease (>50% stenosis in at least one major coronary artery) or abnormal nuclear stress test.
  • The participant is receiving ≥10 L/min of oxygen supplementation by any mode of delivery at rest.
  • The participant has received any PH-approved therapy, including soluble guanylate cyclase inhibitors, endothelin receptor antagonists, or parenteral or oral prostacyclin therapy (excluding vasoreactivity testing) within 60 days of randomization or 5 half-lives. Use of phosphodiesterase type 5 inhibitors and inhaled prostacyclin (e.g., inhaled treprostinil) on stable doses for ≥30 days prior to screening will be allowed irrespective of local approval (as per ESC/ERS 2022).
  • Use of any inhibitors and inducers of cytochrome P450 3A4 (CYP3A4) (e.g., boceprevir, cobicistat, danoprevir and ritonavir, elvitegravir and ritonavir, grapefruit juice, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, paritaprevir and ritonavir and (ombitasvir and/or dasabuvir), posaconazole, ritonavir, saquinavir and ritonavir, telaprevir, tipranavir and ritonavir, telithromycin, troleandomycin, voriconazole, clarithromycin, idelalisib, nefazodone, nelfinavir, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John's wort). For a comprehensive list, please refer to the FDA's Examples of Drugs that Interact with CYP Enzymes and Transporter Systems (FDA 2025).
  • Recent exacerbation of underlying lung disease or active pulmonary/upper respiratory tract infection within 4 weeks of randomization.
  • Any current active malignancy (this does not include localized cancers such as basal or squamous cell carcinoma of the skin). Any history of malignancy that is likely to result in mortality or require significant medical or surgical intervention within the following year.
  • Chronic kidney disease Stage IV or greater (i.e., eGFR ˂30 mL/min/1.73m2) or evidence of acute kidney injury.
  • The participant has a history of congenital heart disease, irrespective of any prior treatment or surgical intervention
  • Use of tobacco, e-cigarette, nicotine, or marijuana products or a significant history of drug or alcohol abuse within 6 months of screening.
  • Acute pulmonary embolism within 90 days of screening.
  • Participation in pulmonary rehabilitation within 90 days of screening. However, participants who were on stable pulmonary rehabilitation for more than 90 days before screening may be considered for the study, provided they meet all other inclusion criteria.
  • Prior or concurrent use of any investigational drug/device/therapy or participation in any investigational study with therapeutic intent within 30 days or 5 half-lives, whichever is longer, before the first dose of the IP.
  • BMI ≥40 kg/m2.
  • Uncontrolled hypertension as evidenced by systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg during the screening period. Participants who fail screening due to high blood pressure can be re-screened once after their antihypertensive medications have been adjusted and their doses have been stable for at least 4 weeks.
  • Concomitant disease that confers a life expectancy of <6 months at screening.
  • The Investigator judges that the participant will be unable to fully participate in the study and complete it for any reason, including inability to comply with the study procedures and treatment of addiction or any other relevant medical or psychiatric conditions.
  • High likelihood of lung transplantation (in the opinion of the Investigator) within 4 months after randomization.
  • History of liver dysfunction, including participants with moderate (Child-Pugh B) or severe (Child-Pugh C) impairment or disordered coagulation.
  • Female participants who are pregnant or breastfeeding.
  • Worse than mild untreated sleep apnea (5-14.9 events/hour). Treated sleep apnea is permitted.
  • Participants with a prior diagnosis of connective tissue diseases, e.g., systemic sclerosis (scleroderma), systemic lupus erythematosus, Sjogren's disease, polymyositis/dermatomyositis/antisynthetase syndrome, or rheumatoid arthritis.
  • Other Exclusions
  • History of allergic or anaphylactic reaction to mirivadelgat or to any component of the excipient.
  • Previous exposure to mirivadelgat.
  • Diagnostic Assessments
  • The following laboratory parameters are excluded:
  • Hemoglobin <10 g/dL (100 g/L).
  • White blood cells (WBC) <3000/µL (<3000/mm3).
  • Platelet count <70,000/µL (70,000/mm3).
  • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 or evidence of acute kidney injury.

Trial locations and contacts

11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Bassem Elmankabadi, MD contact

+1 562-310-8718

Bassem.elmankabadi@foreseepharma.com

Yisheng Lee, MD contact

408-823-4807

yisheng.lee@foreseepharma.com

11 sites in 2 countries

Taiwan9 sites, 6 recruiting

  • Hualien Tzu Chi Hospital

    Hualien City, Taiwan, 970

    Wei-Tung Lin, 866-988431106, tonton711223@gmail.com

    Wei-Hsin Liu, M.D.

    Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, Taiwan

    Terminated

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813

    Terminated

  • Taichung Veterans General Hospital

    Taichung, Taiwan, 407219

    Hui-Chih Yang, 866-04-23592525 ext. 6523, gina2066@gmail.com

    Pin-Kuei Fu, M.D.

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, Taiwan, 704

    Terminated

  • National Taiwan University Hospital

    Taipei, Taiwan, 100225

    Sui-Han Chen, 866-2 2312-3456 ext. 265445, suihanchen@hotmail.com

    Ping-Hung Kuo, M.D.

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, Taiwan, 11217

    Chun-Yi Lin, 0955-636-508, cylin23@vghtpe.gov.tw

    Coka Wang, 866-0989-532-530, Swwang3@vghtpe.gov.tw

    Recruiting

  • MacKay Memorial Hospital

    Taipei, 104

    Yu-Ping Huang, 886-0975-835-863, a6284@mmh.org.tw

    Yih-Jer Wu, MD

    Recruiting

  • Chang Gung Memorial Hospital - Linkou Branch

    Taoyuan City, Taiwan

    Yi-Ping Chi, 886-0978-055-798, chiyiping1016@gmail.com

    Wan-Jing Ho, M.D.

    Recruiting

Other trials in Taiwan

Bosnia and Herzegovina2 sites, 2 recruiting

  • University Clinical Centre of the Republic of Srpska

    Banja Luka, 78000

    Not yet recruiting

  • Clinical Center of the University of Sarajevo

    Sarajevo, 71000

    Not yet recruiting

Other trials in Bosnia and Herzegovina

About this study

Official title: 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)

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.

Read more

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

Read the detailed description

The study is a phase 2, multinational, double-blind, 3-arm study to evaluate the safety and efficacy of mirivadelgat, an aldehyde dehydrogenase 2 activator, in adult subjects (aged 18 to 85 years) with PH-ILD. Participants must have a confirmed diagnosis of ILD as defined by the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and/or Latin American Thoracic Society (ALAT) guidelines (Raghu, 2018). The diagnosis is based on a HRCT either performed at screening or within 180 days prior to screening or a historical surgical biopsy (or other appropriate tissue sampling (e.g., cryobiopsy)) and an RHC performed at screening.

To be eligible for the study, a participant must be willing to undergo a Right Heart Catheterization (RHC) during screening and at the Week 12 Visit (at the end of study treatment). Participants on chronic treatment for underlying pulmonary diseases must be on a stable/optimized dose for ≥30 days prior to screening and have been receiving treatment for ≥90 days prior to screening.

The study will enroll approximately 126 participants, assuming a drop-out rate of 20%, to obtain 99 evaluable participants (33 evaluable subjects in each cohort).

Study visits will include a Screening Visit; Visit 2 (Study Day 1); Weeks 2, 3, 4, 6, 8,10, and 12 Visits (+/ 3 days); and a safety Follow-up Visit (+/ 3 days) after the Week 12 Visit. Visits on Weeks 2, 3, 6, and 10 will be conducted by phone calls.

Being tested
Mirivadelgat, placebo
Keywords
PH-ILD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MirivadelgatDrug

    Also called FP-045

    Selective aldehyde dehydrogenase 2 (ALDH2) activator

  • placeboDrug

    placebo

Study groups in NCT06475781
Study groupRoleWhat they receive
150 mg mirivadelgatExperimental150 mg mirivadelgat once daily
Receives: Drug: Mirivadelgat
300 mg mirivadelgatExperimental300 mg mirivadelgat once daily
Receives: Drug: Mirivadelgat
placeboPlacebo comparatorplacebo once daily
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulmonary Vascular Resistance (PVR)

    The mean change from baseline to Week 12 in PVR assessed by right heart catheterization (RHC) for mirivadelgat vs. placebo.

    Measured: 12 weeks

Secondary outcomes (6)

  1. 6-minute walk distance

    The mean change from baseline to Week 12 in the 6-minute walk distance

    Measured: 12 weeks

  2. Time to clinical deterioration from baseline to Week 12 for any of the following ADJUDICATED clinical events

    • Death (all-cause mortality).
    • Hospital admission greater than 24 hours due to worsening of pulmonary hypertension.
    • Worsening of pulmonary hypertension resulting in the need for lung transplant or balloon atrial septostomy.
    • Initiation of parenteral prostanoid therapy, initiation of oxygen therapy, initiation of any other pulmonary hypertension-specific therapies, or need for an increase of diuretics for more than 4 weeks due to worsening of pulmonary hypertension.
    • Disease progression.
    • A decrease of more than 15% from the baseline in the 6-minute walk distance test combined with World Health Organization (WHO) functional class III or IV symptoms at 2 consecutive visits separated by at least 7 days.

    Measured: 12 weeks

  3. Long-term prognostic risk factors

    The mean change from baseline to Week 12 of long-term prognostic risk factors of plasma/serum N-terminal pro-brain natriuretic peptide (NT-ProBNP), C-terminal procollagen I (PICP), N-terminal procollagen I (NICP or PINP), and N-terminal procollagen III (NIIICP or PIIINP).

    Measured: 12 weeks

  4. Patient-reported outcome measures (PROMS): (SF)-36v2

    The change from baseline to Week 12 in the Short Form (SF)-36v2 Health Survey with Scale 0 to 100 (mean is 50), 0 is worst, 100 is best

    Measured: 12 weeks

  5. Patient-reported outcome measures (PROMS): WIQ

    The change from baseline to Week 12 in the Walking Impairment Questionnaire (WIQ) with percentage scale ranging from 0% (worst) to 100% (best)

    Measured: 12 weeks

  6. Patient-reported outcome measures (PROMS): PAH-SYMPACT

    The change from baseline to Week 12 in the Pulmonary Arterial Hypertension-Symptoms and Impact Questionnaire (PAH-SYMPACT) with each point scored from 0 (best) to 4 (worst)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start1 Mar 2025
  3. Primary completionFeb 2028 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose Study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06475781
Sponsor's protocol ID
FP-045C-23-001
Acronym
WINDWARD
Status last verified
Sep 2026
First submitted
12 Jun 2024
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mirivadelgat in people with Group 3 Pulmonary Hypertension, run by Foresee Pharmaceuticals Co., Ltd. at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Taiwan, Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bassem Elmankabadi, MD (+1 562-310-8718, Bassem.elmankabadi@foreseepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulmonary Vascular Resistance (PVR) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06475781.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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