PF-07868489 for Pulmonary Hypertension

Recruiting at 23 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

Must not be taking: GLP-1 agonists

Disqualifiers: Transplant, Hepato-pulmonary syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the long-term safety and effects of a new treatment, PF-07868489, for people with pulmonary arterial hypertension (PAH). PAH is a condition where high blood pressure in the lungs makes it hard for the heart to pump blood, potentially harming the heart. Participants will receive doses of PF-07868489 (an experimental treatment) every four weeks, with both participants and their healthcare providers aware of the treatment being administered. Those who completed a previous study with this treatment and did not experience worsening PAH or major health issues during that study are well-suited for this trial. As a Phase 2 trial, this study focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

Is there any evidence suggesting that PF-07868489 is likely to be safe for humans?

Research has shown that PF-07868489 is under investigation for its safety in treating pulmonary arterial hypertension (PAH). In one study, researchers tested this medication over 24 weeks to assess patient tolerance. The study monitored health indicators like heart rate and blood pressure to ensure safety. Early results suggest that the treatment is generally well-tolerated.

PF-07868489 is currently in Phase 2 of development, indicating it has already been tested in a smaller group for serious side effects. Now, it is being tested in a larger group to better understand its safety and efficacy. This phase allows researchers to gather more detailed information about the treatment's safety over an extended period. Prospective clinical trial participants might find reassurance in the ongoing research into the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pulmonary hypertension?

Most treatments for pulmonary hypertension focus on dilating blood vessels or reducing blood pressure, such as endothelin receptor antagonists, phosphodiesterase-5 inhibitors, and prostacyclins. But PF-07868489 works differently by potentially targeting the underlying causes of the disease, rather than just managing symptoms. This treatment is particularly exciting because it is administered subcutaneously every four weeks, which could be more convenient for patients compared to daily medications. Researchers are hopeful that this novel approach can provide more effective and long-lasting relief for those suffering from this condition.

What evidence suggests that PF-07868489 might be an effective treatment for PAH?

This trial is testing PF-07868489 to determine its potential benefits for people with pulmonary arterial hypertension (PAH), a condition characterized by high blood pressure in the arteries between the heart and lungs. Early research suggests that this treatment might help manage PAH by improving heart function and reducing lung blood pressure. Data from previous studies focused on its safety and pharmacokinetics, showing it was generally well-tolerated. Researchers in this trial are closely monitoring heart rate and blood pressure to confirm its effectiveness. Although still under investigation, early signs are promising for addressing this challenging condition. ^{1 2 5 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults who've completed a previous study with PF-07868489 without worsening PAH or hospitalization, can follow the study plan, and don't have major ongoing health issues. It's not for those with liver-related lung problems, on GLP-1 agonist medications, awaiting transplants, or planning surgery for PAH.

Inclusion Criteria

I am willing and able to follow all study requirements.

I am over 18 and completed a study with PF-07868469.

Participants must not have worsening or hospitalization for worsening PAH during the qualifying study

Exclusion Criteria

Participants with an ongoing major health issue in the qualifying study, which in the opinion of the study doctor could make the participant not qualify for this study

I am scheduled for a transplant and surgery for pulmonary arterial hypertension.

I have or had liver-related lung problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label extension

Participants receive subcutaneous doses of PF-07868489 every 4 weeks to assess long-term safety and efficacy

Long-term

1 visit every 4 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PF-07868489

Trial Overview

The trial studies long-term safety and effects of PF-07868489 in treating Pulmonary Arterial Hypertension (PAH). Participants know what medication they're receiving in this open-label extension study that continues from an earlier clinical trial.

How Is the Trial Designed?

Group I: Open Label Experimental Treatment 1 Intervention

Participants will receive subcutaneous doses of PF-07868489 every 4 weeks

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06137742

NCT06137742 | A Study to Learn About the ...

The purpose of the study is to learn how the study medicine called PF-07868489 is tolerated and acts in healthy adult people and people with pulmonary ...

2.

isrctn.com

isrctn.com/pdf/65235904

A study to learn how the study medicine called PF- ...

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

3.

clinicaltrials.eu

clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-pf-07868489-in-patients-with-pulmonary-arterial-hypertension/

Study on the Safety and Effects of PF-07868489 in Patients ...

The study will track various health parameters, such as heart rate and blood pressure, to ensure the safety and effectiveness of the treatment.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07073820?viewType=Table&rank=7

NCT07073820 | A Study to Learn About the ...

The purpose of this study is to learn about the long-term safety, tolerability and effects of the study medicine (PF-07868489) for the possible treatment of PAH ...

5.

pfizerclinicaltrials.com

pfizerclinicaltrials.com/find-a-trial/nct07073820-pulmonary-hypertension-trial

Clinical Trial for Pulmonary Hypertension.

The purpose of this study is to learn about the long-term safety, tolerability and effects of the study medicine (PF-07868489) for the possible treatment of PAH ...

6.

isrctn.com

isrctn.com/ISRCTN65235904

A study to learn how the study medicine called PF ...

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

7.

ph-ksp.com

ph-ksp.com/pf-07868489-pfizers-new-biologic-enters-phase-2-for-pulmonary-arterial-hypertension/

PF-07868489: Pfizer's New Biologic Enters Phase 2 for ...

PF-07868489 is currently in Phase 2 development and has received Orphan Drug designation in the US. The study (NCT06137742) has two parts: Part ...