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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

Verified siteInvestigationalNo placebo
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What is this trial about?

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

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.

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

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

4 criteria

  • 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 trial?

12 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

PF-07868489 – This is an experimental medication currently being studied in Phase 2 clinical trials for the treatment of Pulmonary Arterial Hypertension, a condition where blood pressure in the arteries of the lungs becomes abnormally high. The medication is given as an injection under the skin (subcutaneous administration) and is being tested to see if it is safe and effective when used repeatedly over a long period of time. As this drug is still in clinical trials, it has not yet been approved for general use and researchers are working to understand how well it works and what side effects it may cause in patients with this serious lung condition.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521155-23-00Protocol codeC5001004Estimated enrolment35 patientsSponsorPfizer Inc.

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