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NCT Number: NCT07073820

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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. PAH is a condition in which there is high blood pressure in the arteries that carry blood from the heart to the lungs. This high pressure makes it harder for the heart to pump blood through those lungs, potentially damaging the right side of the heart.

This is an open-label study. Which means that both the healthcare providers and the study participants are aware of the medicine being given. This study is also an extension study with study medicine (PF-07868489). An extension study allows patients from an earlier clinical study (also called as qualifying study) to continue participating to assess long-term benefits and safety of the medicine.

Recruiting

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

This study is seeking participants who are:

  • aged 18 years or older at screening of the previous study and completed the required treatment duration with PF-07868469 and other assessments at the end of that study.
  • willing and able to abide with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • do not have worsening or hospitalization for worsening PAH during the qualifying study.
  • not on placement for a surgery to replace any tissue or part of the body (transplant), and planned surgery for PAH.
  • do not have 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.
  • not suffering from or in the past have suffered from hepato-pulmonary syndrome (liver-related lung problem).
  • not currently prescribed or taking medicines called as GLP-1 agonist.

Treatment and study plan

PF-07868489

Drug

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

Primary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline up to week 111

  2. Number of Participants With Change From Baseline in Laboratory Tests Results

    Time frame: Baseline up to week 111

  3. Number of Participants With Vital Sign Abnormalities

    Time frame: Baseline up to week 111

Secondary outcomes

  1. Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters

    Time frame: Baseline up to week 111

  2. Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration

    Time frame: Baseline up to week 104

  3. Minimum Observed Plasma Trough Concentration (Cmin), as data permits

    Time frame: Baseline up to week 111

  4. Incidence of Anti-Drug Antibody (ADA)

    Time frame: Baseline up to week 111

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 2, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-07868489 ADMINISTERED TO ADULT PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 18, 2025
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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