Study on the Safety and Effects of PF-07868489 in Patients with Pulmonary Arterial Hypertension

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What is this study about?

This clinical trial is focused on studying a condition known as Pulmonary Arterial Hypertension (PAH). PAH is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. The study will evaluate a new treatment called PF-07868489, which is administered as a solution for injection. The trial will also include a comparison with a placebo to assess the effectiveness and safety of the treatment.

The purpose of the study is to learn how the medicine PF-07868489 is tolerated and how it acts in both healthy adults and those with PAH. Participants will receive either the study medicine or a placebo. The study will monitor how the medicine affects the body, including changes in blood pressure and other health indicators. The trial will also look at how the medicine influences a specific blood marker related to heart function, known as NTproBNP, over a period of time.

Participants in the study will receive repeat doses of the study medicine or placebo and will be monitored for any changes in their health. The study will track various health parameters, such as heart rate and blood pressure, to ensure the safety and effectiveness of the treatment. The trial aims to provide valuable information on the potential benefits of PF-07868489 for individuals with Pulmonary Arterial Hypertension.

1 joining the study

Upon joining the study, you will be asked to sign an informed consent form. This document confirms your willingness to participate and your understanding of the study’s requirements.

You must be at least 18 years old and meet specific health criteria related to pulmonary arterial hypertension (PAH).

2 initial assessments

You will undergo a series of initial assessments to confirm your eligibility. These assessments include reviewing your medical history and performing tests such as right heart catheterization (RHC) and pulmonary function tests (PFTs).

These tests help ensure that you meet the study’s health criteria and do not have any conditions that would exclude you from participating.

3 randomization

Once eligibility is confirmed, you will be randomly assigned to receive either the study medication, PF-07868489, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the study drug.

This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

4 treatment phase

During the treatment phase, you will receive the assigned treatment through subcutaneous injections. This means the medication is injected under the skin.

The study involves single escalating doses for healthy participants and repeat doses for those with PAH. The exact dosage and frequency will be determined by the study protocol.

5 monitoring and follow-up

Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and other assessments to track your response to the treatment.

You will be asked to report any side effects or changes in your health. The study team will also measure changes in specific health markers, such as NTproBNP levels and your ability to walk a certain distance in six minutes.

6 end of study

At the end of the study, you will undergo final assessments to evaluate the overall effects of the treatment.

The study is expected to conclude by June 2027, and you will be informed about the results and any further steps if necessary.

Who Can Join the Study?

Participants must be at least 18 years old or the minimum age of consent according to local regulations.
Participants must have signed an informed consent form.
Participants must be willing and able to attend all scheduled visits, follow the treatment plan, and complete all required tests and procedures.
Participants must have a confirmed diagnosis of Pulmonary Arterial Hypertension (PAH) through a test called Right Heart Catheterization (RHC). This includes specific types of PAH such as idiopathic, heritable, drug-induced, or associated with connective tissue disease.
Participants must have PAH classified as WHO functional class II or III, which describes the severity of symptoms.
Participants must have a specific measurement from the RHC test called Pulmonary Vascular Resistance (PVR) of at least 400 dyn·sec/cm⁵ (5 Wood units).
Participants must have had Pulmonary Function Tests (PFTs) to rule out other lung conditions, unless they are a smoker with a significant smoking history.
Participants must have documentation in their medical history that Chronic Thromboembolic Pulmonary Hypertension (CTEPH) has been excluded.
Participants must be able to walk between 150 meters and 500 meters in a test called the 6-Minute Walk Distance (6MWD), with consistent results.
Participants must be on a stable dose of at least two standard PAH treatments for at least 60 days before the study.
Participants must have a Body Mass Index (BMI) between 16 and 35 kg/m².

Who Cannot Join the Study?

Patients with any other serious health condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent heart attack or stroke.
Patients who have a history of severe allergic reactions to medications.
Patients who are currently participating in another clinical trial.
Patients who have a history of drug or alcohol abuse.
Patients who have uncontrolled high blood pressure.
Patients who have severe liver or kidney disease.
Patients who have been diagnosed with cancer in the past five years.
Patients who have a history of lung diseases other than Pulmonary Arterial Hypertension.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
University Medicine Greifswald	Greifswald	Germany
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Katholieke Universiteit te Leuven	Leuven	Belgium
CHU Grenoble Alpes	La Tronche	France
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Onassis Cardiac Surgery Center	Kallithea	Greece
University General Hospital Of Thessaloniki Ahepa	Thessaloniki	Greece
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l.	Palermo	Italy
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
Itocjlcgr Fmy Cltxaudx Ayu Ekddmvzsgglg Mfhitfzf	Prague	Czechia
Huqjjhdi Urvpzcnbiewtu Mbrwzkj De Vnrfcgnjdv	Santander	Spain
Fwhnbipum Pqse Lf Ifffitsynylhw Bsixxaqmk Dlg Hongcdmx Uzhrhwxhgzidm Ly Pih	Madrid	Spain
Iojvgeqa dw Ckytzlqltosg Himepwxmtuo Uzpupzevtaegi dd Shmha Ejpmybw (bztcjyt	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	08.06.2025
Czechia	Not recruiting	08.06.2025
France	Not recruiting	08.06.2025
Germany	Not recruiting	08.06.2025
Greece	Recruiting	08.06.2025
Italy	Not recruiting	08.06.2025
Spain	Not recruiting	08.06.2025

Trial locations

Investigated drugs:

PF-07868489

PF-07868489 is a new medication being tested in this clinical trial. It is designed to help people with a condition called Pulmonary Arterial Hypertension (PAH), which is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. The trial is looking at how safe and tolerable this medication is when given in repeated doses. It also aims to see how the medication affects certain markers in the blood that are related to heart stress. This could help doctors understand if the medication is working to improve the condition of people with PAH.

Investigated diseases:

Pulmonary arterial hypertension

Pulmonary Arterial Hypertension – Pulmonary Arterial Hypertension is a condition characterized by high blood pressure in the arteries that supply the lungs. This disease causes the small arteries in the lungs to become narrowed or blocked, leading to increased resistance to blood flow. As the condition progresses, the heart must work harder to pump blood through the lungs, which can lead to heart strain and enlargement. Over time, this increased workload can weaken the heart muscle and reduce its ability to pump blood effectively. Symptoms often include shortness of breath, fatigue, dizziness, and swelling in the ankles or legs. The progression of the disease can vary, with symptoms gradually worsening over time.

Trial ID:

2024-514064-17-00

Protocol code:

C5001001

NCT ID:

NCT06137742

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effects of PF-07868489 in Patients with Pulmonary Arterial Hypertension

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