A Study of PF-07868489 Safety and Effectiveness in Adults with Pulmonary Arterial Hypertension Who Participated in a Previous PF-07868489 Trial

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What is this study about?

This study is looking at Pulmonary Arterial Hypertension, which is a condition where the blood pressure in the arteries of the lungs becomes abnormally high, making it harder for the heart to pump blood through the lungs. The treatment being tested is called PF-07868489, which is given as an injection under the skin. This medication is a type of biologic medicine, which means it is made from living cells rather than chemical processes.

The purpose of the study is to evaluate the long-term safety and how well the body tolerates repeated doses of PF-07868489 in people with this lung blood pressure condition. This is an extension study, which means it is designed for people who have already participated in an earlier clinical trial with the same medication and completed at least 20 weeks of treatment in that previous study. The study will continue for up to 104 weeks, which is about two years.

During the study, participants will receive regular injections of the medication under the skin and will attend scheduled visits where various health checks will be performed. These checks will include monitoring for any unwanted effects or serious health problems, measuring vital signs such as blood pressure and heart rate, taking blood samples for laboratory tests, and performing heart recordings using an electrocardiogram. The study will also measure certain substances in the blood and check whether the body develops any immune response to the medication over time.

1 Entry into the extension study

This study is an extension for participants who have already completed at least 20 weeks of treatment and week 24 procedures in a previous study with PF-07868489.

The study involves receiving PF-07868489, which is a solution for injection given under the skin (subcutaneous injection).

This extension study will evaluate the long-term safety and effectiveness of repeated doses of the medication.

2 Ongoing treatment phase

During the study, repeated subcutaneous doses of PF-07868489 will be administered. The medication is injected under the skin at scheduled intervals.

The specific dosage, frequency, and duration of treatment are not provided in the available information.

Treatment will continue for an extended period as part of this long-term study.

3 Regular monitoring visits

Scheduled visits will occur throughout the study to monitor safety and response to treatment.

Vital signs will be measured regularly. These include blood pressure, heart rate, breathing rate, and temperature.

Blood tests will be performed to check how the body is responding to the medication and to monitor organ function.

An electrocardiogram (also called an ECG) will be performed. This is a test that records the electrical activity of the heart to check heart rhythm and detect any changes.

4 Safety assessments

Throughout the study, any adverse events will be recorded. These are any unwanted medical occurrences or symptoms that happen during the study.

Serious adverse events are more significant health problems that require immediate attention and will be carefully monitored.

The study will track whether any adverse events are related to the study medication.

5 Effectiveness measurements

Blood tests will measure NT-pro-BNP, which is a substance in the blood that can indicate how well the heart is functioning. Changes from the starting level will be tracked.

Blood samples will be taken to measure the amount of PF-07868489 in the bloodstream, specifically the lowest concentration between doses.

The body’s immune response to the medication will be monitored by checking for antidrug antibodies. These are proteins the immune system might produce in response to the medication.

6 Continuation of study participation

The study is expected to continue until 2029, providing long-term data on the safety and effectiveness of PF-07868489.

All scheduled visits, laboratory tests, and lifestyle requirements specified in the study plan must be followed.

Participation continues as long as the treatment remains appropriate and safe.

Who Can Join the Study?

You must be 18 years of age or older at the time of screening for the previous study, or meet the minimum age required by local rules where you live
You must have completed at least 20 weeks of treatment and the week 24 study procedures in the previous study
You must be willing and able to attend all scheduled visits, follow the treatment plan, complete laboratory tests (blood and other tests done in a lab), follow lifestyle requirements, and complete other study procedures
You must be able to give signed informed consent, which means you understand and agree in writing to participate in the study, and you can follow the requirements and rules described in the consent form and study plan

Who Cannot Join the Study?

Pregnant women or women who are breastfeeding cannot participate in this study because the medication being tested could potentially harm the unborn baby or nursing infant.
Patients with severe liver disease, which means the liver (the organ that helps clean your blood and digest food) is not working properly, cannot join the study.
Patients with severe kidney disease, which means the kidneys (the organs that filter waste from your blood and make urine) are not functioning well enough, are not eligible.
Patients who have had a recent heart attack (damage to the heart muscle due to blocked blood flow) within the past 3 months cannot participate.
Patients with uncontrolled high blood pressure, meaning blood pressure that remains too high even with medication, cannot join the study.
Patients with certain types of lung diseases other than pulmonary arterial hypertension that significantly affect breathing and lung function are excluded.
Patients who have a known allergy or severe reaction to the study medication or any of its ingredients cannot participate.
Patients taking certain medications that could interact dangerously with the study drug are not eligible.
Patients with active infections, meaning current infections that require treatment, cannot join until the infection is resolved.
Patients with certain blood disorders, which are conditions affecting the blood cells or blood clotting, may be excluded.
Patients who have participated in another clinical trial (research study testing new treatments) within a certain time period before this study cannot join.
Patients with certain types of cancer that are currently being treated or were recently treated may not be eligible.

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
Ideaveasc Fme Ccbuhxeu Ars Engwgjppcvsh Mvchwlex	Prague	Czechia
Hqomzezu Ukzgtfqbuxucz Mpneuiq Dt Vovvtwruws	Santander	Spain
Fwfiurmok Pmwi Lm Iqxckgtvspkzj Byloersvx Dgz Hsxgmdov Utgyozgrondww Lb Pxe	Madrid	Spain
Idybrlcn di Ccgsilqscecy Htdatwgkrqp Uyzbfukxthyem dn Swblw Ehocyju (czwifny	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	18.01.2026
Czechia	Recruiting	18.01.2026
France	Recruiting	18.01.2026
Germany	Recruiting	18.01.2026
Greece	Recruiting	18.01.2026
Italy	Recruiting	18.01.2026
Spain	Recruiting	18.01.2026

Trial locations

Investigated drugs:

PF-07868489

PF-07868489 is an investigational medication being studied for the treatment of pulmonary arterial hypertension, which is a condition where blood pressure in the arteries of the lungs is abnormally high. This medication is given as an injection under the skin. The purpose of this trial is to learn more about how safe this medication is when used over a long period of time and how well it works in adults with this lung condition.

Investigated diseases:

Pulmonary arterial hypertension

Pulmonary Arterial Hypertension – Pulmonary arterial hypertension is a condition where the blood pressure in the arteries of the lungs becomes abnormally high. The small blood vessels in the lungs become narrowed, blocked, or damaged, making it harder for blood to flow through them. As a result, the right side of the heart must work harder to pump blood through the lungs. Over time, the heart muscle weakens and becomes less able to pump blood effectively. People with this condition may experience shortness of breath, fatigue, chest pain, and dizziness during physical activity. The disease typically progresses gradually, with symptoms becoming more severe as the condition advances.

Trial ID:

2025-521155-23-00

Protocol code:

C5001004

Trial Phase:

Therapeutic exploratory (Phase II)

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A Study of PF-07868489 Safety and Effectiveness in Adults with Pulmonary Arterial Hypertension Who Participated in a Previous PF-07868489 Trial

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