Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

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

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

11 criteria

  • 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 trial?

10 criteria

  • 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**.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

What is already known about the treatment

PF-07868489 – This medication is administered through subcutaneous (SC) injections, meaning it is injected under the skin. It is currently being studied in clinical trials to assess its safety and effectiveness, particularly for treating Pulmonary Arterial Hypertension (PAH). The main purpose of this medication is to help manage PAH, a condition characterized by high blood pressure in the arteries of the lungs. At the molecular level, PF-07868489 works by influencing certain biological pathways to reduce the strain on the heart and improve blood flow in the lungs. It is classified as a pharmacological agent under investigation for its potential benefits in cardiovascular health.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514064-17-00Protocol codeC5001001Estimated enrolment94 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.