RecruitingPhase I/IIInterventional

A study to learn how the study medicine called PF-07868489 is tolerated and acts in people with pulmonary arterial hypertension

This research study is investigating a new medicine called PF-07868489 for people living with pulmonary arterial hypertension (PAH). PAH is a serious condition affecting the blood vessels in the lungs, making everyday activities difficult. This study aims to understand how safe the new medicine is and how the body reacts to it. It’s a first-step study (Phase I/II) to help researchers learn more before it can be widely used. Participants must be adults with a confirmed diagnosis of PAH and meet certain health requirements. While the study might not directly benefit participants, it could help develop new treatments for PAH in the future.

At a glance

Status

Recruiting

Phase

Phase I/II

Sponsor

Pfizer Europe MA EEIG

Enrolment target

Start

07 Jun 2025

Estimated completion

12 Jan 2027

Pulmonary arterial hypertension

What is this study about?

This study is exploring a new medicine called PF-07868489. It's for people with a condition called pulmonary arterial hypertension, often shortened to PAH. PAH causes high blood pressure in the arteries leading from your heart to your lungs, which makes your heart work harder and can make you feel breathless and tired. The main goal of this study is to see if this new medicine is safe and how well people tolerate it. Researchers also want to understand how the medicine works inside the body, which is important for developing effective treatments in the future.

This is an early-stage study, known as Phase I/II. This means it's one of the first times the medicine is being tested in people with PAH. Researchers need to gather important information about its safety and effects before it can move on to larger studies. The study information doesn't say exactly what taking part will involve day-to-day, but generally, early studies like this involve close monitoring of your health.

Taking part in studies like this is really important because it helps scientists learn more about new medicines. Even if a new medicine doesn't fully help a participant in the study, the information gathered can still be very valuable for developing better treatments for future patients with PAH.

Key takeaways

It's a study for a new medicine for pulmonary arterial hypertension (PAH).
The main goals are to check the medicine's safety and how it works.
It's an early-stage study, so direct benefits might not be known yet.
Participants must be adults with confirmed PAH and meet specific health criteria.
Taking part involves clinic visits, tests, and closely monitoring your health.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of pulmonary arterial hypertension (PAH). Your PAH should also fit certain types, such as those that are inherited or caused by certain drugs, or if it's linked to other conditions like connective tissue disease.

Your PAH would be classed as either 'WHO functional class II or III', which means it impacts your daily activities moderately or significantly. You would also need to have certain measurements from heart and lung tests, and already be on a stable treatment plan for your PAH. Your body mass index (BMI) should be between 16 and 35. You'll also need to be able to walk a certain distance in six minutes and shouldn't have other serious lung problems.

Before you can officially join, you'll have checks, including a special heart test called a 'right heart catheterisation'. You'll also need to be willing to follow all the study rules, including attending appointments and having specific tests. If you're pregnant, planning to become pregnant, or breastfeeding, you won't be able to take part.

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.

Are you 18 years old or older?
Do you have a confirmed diagnosis of pulmonary arterial hypertension (PAH)?
Are you able to attend all study appointments and follow instructions?
Are you currently pregnant, planning to become pregnant, or breastfeeding?
Are you using effective contraception if you are a woman of childbearing age?

Answer every question to see your result.

What does participation involve?

The detailed steps of what taking part involves aren't fully described yet. However, typically in studies like this, you would have regular hospital or clinic visits where you would receive the study medicine, have various health checks, and undergo tests like blood samples, heart scans, and lung function assessments. You would also have a right heart catheterisation at the start and end of the study.

The study medicine, PF-07868489, would likely be given as an injection. The full study is expected to run from November 2024 to January 2027.

Potential risks and benefits

There's no information yet about direct benefits for people taking part in this study. However, contributing to research can help others with PAH in the future. As with any medicine, there are risks; taking the study drug might make you feel unwell, or it could cause allergic reactions like trouble breathing, swelling, or skin rashes. You might also have a reaction where the injection is given. A procedure called right heart catheterisation, which involves a thin tube being put into a vein, carries small risks like bleeding, abnormal heart rhythms, or lung collapse. You'll be closely monitored for any side effects, and you are free to leave the study at any time.

Locations (4)

Hammersmith Hospital
Approximate
London, United Kingdom
Royal Brompton Hospital
Approximate
London, United Kingdom
Royal Free Hospital
Approximate
London, United Kingdom
Golden Jubilee National Hospital
Approximate
Clydebank, United Kingdom

Common questions

What is pulmonary arterial hypertension (PAH)?

PAH is a serious condition where blood pressure in the arteries going to your lungs becomes too high, making your heart work harder.

What is PF-07868489?

It's a new medicine being studied to see if it's safe and how it works for people with PAH.

What does 'Phase I/II' mean?

It's an early stage of research. Phase I checks safety, and Phase II starts looking at effectiveness and dosage in a small group of patients.

Will I get the actual medicine or a placebo?

The study mentions it's 'randomised, double-blind, placebo-controlled', meaning some will get the medicine and some a dummy drug, and neither you nor the doctors will know which.

What is a right heart catheterisation (RHC)?

It's a procedure where a thin tube is inserted into a large vein to measure pressures in your heart and lungs, helping doctors understand your condition better.

How to find out more

Sarah Hughes

Sarah.Hughes@pfizer.com 447340276799 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.