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

NCT07073820 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: C50010042025-521155-23-00
• Study Type: interventional
• Target: 36
• Locations: 14 countries
• Sites: 48

Brief Summary

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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (3)

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

  Baseline up to week 111

• Number of Participants With Change From Baseline in Laboratory Tests Results

  Baseline up to week 111

• Number of Participants With Vital Sign Abnormalities

  Baseline up to week 111

Secondary Outcomes (4)

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

  Baseline up to week 111

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

  Baseline up to week 104

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

  Baseline up to week 111

• Incidence of Anti-Drug Antibody (ADA)

  Baseline up to week 111

Study Arms (1)

Open Label

EXPERIMENTAL

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

Drug: PF-07868489

Interventions

PF-07868489 DRUG

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

Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (48)

UC Davis Health Medical Center

Sacramento, California, 95817, United States

NOT YET RECRUITING

UCSF Health St. Mary's Hospital

San Francisco, California, 94117, United States

RECRUITING

Heart and Vascular Center

San Francisco, California, 94143, United States

RECRUITING

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Norton Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

Norton Pulmonary Specialists

Louisville, Kentucky, 40202, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

NOT YET RECRUITING

Clinical Trials Unit at Eastowne Medical Office Building

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Pulmonary Hypertension Clinical Trials Office at Eastowne

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Pulmonary Specialty Clinic at Eastowne Medical Office Building

Chapel Hill, North Carolina, 27514, United States

RECRUITING

UNC Hospitals

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Center for Advanced Lung Care

Providence, Rhode Island, 02904, United States

RECRUITING

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

RECRUITING

Pulmonary Hypertension Research Queensland Pty Ltd

Auchenflower, Queensland, 4066, Australia

RECRUITING

HUB Hôpital Erasme

Brussels, 1070, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5A5, Canada

NOT YET RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

NOT YET RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Vseobecna fakultni nemocnice v Praze

Prague, 12808, Czechia

RECRUITING

CHRU de Brest

Brest, Finistère, 29200, France

RECRUITING

Centre Hospitalier Universitaire de Saint-Etienne, Hôpital Nord

Saint-Priest-en-Jarez, 42055, France

RECRUITING

Thoraxklinik-Heidelberg gGmbH

Heidelberg, Baden-Wurttemberg, 69126, Germany

RECRUITING

Universitätsklinikum Regensburg

Regensburg, Bavaria, 93053, Germany

RECRUITING

Universitaetsklinikum Giessen und Marburg GmbH

Giessen, Hesse, 35392, Germany

RECRUITING

Universitätsmedizin Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

RECRUITING

Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"

Chaïdári, Attica, 12461, Greece

RECRUITING

Onassis Hospital

Kallithea, Attica, 17674, Greece

NOT YET RECRUITING

AHEPA University General Hospital of Thessaloniki

Thessaloniki, Central Macedonia, 54636, Greece

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza E Brianza, 20900, Italy

NOT YET RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

RECRUITING

St. Marianna University Hospital

Kawasaki, Kanagawa, 216-8511, Japan

RECRUITING

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

NOT YET RECRUITING

National Hospital Organization Okayama Medical Center

Okayama, 701-1192, Japan

RECRUITING

Gachon University Gil Medical Center

Incheon, Incheon-gwangyeoksi [incheon], 21565, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea

RECRUITING

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea

RECRUITING

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de, 28046, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hammersmith Hospital

London, Greater London, W12 0HS, United Kingdom

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): July 18, 2028
• Study Completion (Estimated): July 18, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (2); GB (1); BE (2); ES (3); CN (4); AU (2); CA (2); KR (4); DE (5); US (13); JP (4); FR (2); GR (3); CZ (1)