AuthorisedTherapeutic exploratory (Phase II)Interventional

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 WINDWARD study

Interstitial lung disease causes scarring in the lungs, which can also lead to high blood pressure in the lung blood vessels. This combined condition, known as PH-ILD, can cause severe breathlessness, tiredness, and limits everyday activity. Right now, doctors have very few treatments to help manage it. The WINDWARD study is an international clinical trial testing an experimental drug called mirivadelgat. Scientists hope this medicine helps open narrowed lung vessels and lowers blood pressure inside the lungs. Participants will take either mirivadelgat or a dummy pill (placebo) for 12 weeks. To see how well the medicine works, doctors will measure blood pressure in the lungs using a small tube called a catheter, check how far participants can walk in six minutes, and ask them about their daily symptoms. This trial aims to find out if mirivadelgat is safe and effective.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Foresee Pharmaceuticals USA Inc.

Enrolment target

Start

19 Oct 2026

Pulmonary Hypertension associated with Interstitial Lung Disease

What is this study about?

Interstitial lung disease (ILD) causes inflammation and scarring in the delicate tissues of the lungs. Over time, this scarring can put extra strain on the blood vessels that carry blood from the heart to the lungs, making them stiff and narrow. When this happens, blood pressure in the lungs rises. This linked condition is called pulmonary hypertension associated with interstitial lung disease, or PH-ILD. People living with PH-ILD often experience worsening breathlessness, extreme tiredness, and find it difficult to walk or carry out everyday activities.

Currently, there are very few treatments approved specifically to treat PH-ILD. The WINDWARD clinical trial is testing a new medicine called mirivadelgat. Mirivadelgat works by turning on a natural protective protein in the body. Researchers believe this may help protect the lung vessels, reduce stiffness, and allow blood to flow more freely through the lungs, which could relieve the strain on the heart.

This is a Phase 2 study, which means doctors are testing the medicine in a small group of patients to check both its safety and how well it works. Half of the people in the trial will receive mirivadelgat, and the other half will receive a placebo (a dummy treatment that looks identical but contains no active drug). Comparing the two groups over 12 weeks helps scientists prove whether any improvements in lung pressure and walking ability are truly caused by the study medicine.

Key takeaways

The WINDWARD trial is testing a new drug, mirivadelgat, for pulmonary hypertension linked to lung scarring (PH-ILD).
The study compares the drug against an inactive dummy pill (placebo) over 12 weeks.
Researchers will check if the medicine lowers lung blood pressure, improves walking distance, and eases symptoms.
Participation is voluntary and includes regular clinic visits, walking tests, and heart pressure measurements.
You can leave the study at any point without it affecting your normal NHS treatment.

Who may be eligible?

This clinical trial is looking for men and women aged 18 and older who have been diagnosed with pulmonary hypertension linked to interstitial lung disease (PH-ILD).

To take part, you must be well enough to safely undergo the trial's health checks, including a six-minute walking test and a heart test called a right heart catheterisation.

You may not be able to join if you have other severe heart or lung conditions, recent unstable medical illness, or if you take certain medicines that could interact with the study drug. A doctor on the study team will carefully review your full medical history and current prescriptions to make sure joining is safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am at least 18 years of age.
I have been diagnosed with interstitial lung disease (ILD).
I have also been diagnosed with pulmonary hypertension (high blood pressure in the lungs).
I am able to walk and complete a six-minute walking test.
I am willing to attend regular hospital appointments over roughly 12 to 16 weeks.

Answer every question to see your result.

What does participation involve?

If you decide to join the WINDWARD trial, your participation will last about 12 to 16 weeks. You will be randomly assigned (like flipping a coin) to take either the study drug, mirivadelgat, or a matching placebo. Neither you nor your study doctor will know which one you are taking. You will visit the hospital clinic regularly for check-ups. At the start and at Week 12, doctors will measure the pressure in your lungs using a standard procedure called a right heart catheterisation. You will also complete a six-minute walking test, give blood samples, and fill in questionnaires about your breathing, physical ability, and quality of life.

Potential risks and benefits

Taking part may not directly cure your condition, but you will receive close, specialist medical attention throughout the study, and your participation could help doctors find better treatments for PH-ILD in the future. However, there are risks to consider. Mirivadelgat is an experimental medicine, so it may cause unknown side effects. Procedures like right heart catheterisation and blood tests can cause temporary discomfort, bruising, or soreness. Taking part is entirely voluntary; you can choose to leave the study at any time, and doing so will never affect your standard NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Czechia

Common questions

What is a placebo and why is it used?

A placebo is a dummy pill that looks just like the real medicine but has no active ingredients. It is used so researchers can see if health changes are genuinely caused by mirivadelgat rather than psychological expectation.

Will I know if I am taking mirivadelgat or the placebo?

No. This is a 'double-blind' trial, which means neither you nor your doctor will know which treatment you are taking during the study. This keeps the results fair and unbiased.

What is a right heart catheterisation?

It is a standard hospital procedure where a doctor gently guides a thin, flexible tube through a vein into the right side of your heart and lung blood vessels to accurately measure blood pressure.

Will taking part in this study cost me anything?

No. The study medication, clinic visits, and all trial-related tests are provided free of charge, and travel expenses for hospital visits are often reimbursed.

Can I stop taking part if I change my mind?

Yes. You have the right to withdraw from the trial at any point, for any reason, without giving an explanation and without it affecting your ongoing medical care.