Pulmonary HypertensionPhase 2NCT07073820
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
A Phase 2 study testing PF-07868489 in people with Pulmonary Hypertension, run by Pfizer at 27 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- PF-07868489
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 27 sitesin 10 countries
- Study dates
- 10 Nov 2025to 24 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
27 sites in 10 countries.
27 sites in 10 countries
Germany5 sites
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, Saxony, 01307
Universitaetsklinikum Giessen und Marburg GmbH
Giessen, Hesse, 35392
Universitätsmedizin Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, 69126
Universitätsklinikum Regensburg
Regensburg, Bavaria, 93053
United States4 sites
Mount Sinai Hospital
New York, New York, 10029
UCSF Health St. Mary's Hospital
San Francisco, California, 94117
Heart and Vascular Center
San Francisco, California, 94143
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, 94143
China4 sites
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
South Korea4 sites
Gachon University Gil Medical Center
Incheon, Incheon-gwangyeoksi [incheon], 21565
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 06351
Japan3 sites
St. Marianna University Hospital
Kawasaki, Kanagawa, 216-8511
Kobe University Hospital
Kobe, Hyōgo, 650-0017
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
Australia2 sites
Pulmonary Hypertension Research Queensland Pty Ltd
Auchenflower, Queensland, 4066
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
United Kingdom1 site
Hammersmith Hospital
London, Greater London, W12 0HS
About this study
Official 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
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
- Being tested
- PF-07868489
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07868489Drug
Participants will receive subcutaneous doses of PF-07868489 every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Participants will receive subcutaneous doses of PF-07868489 every 4 weeks Receives: Drug: PF-07868489 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Baseline up to week 111
Number of Participants With Change From Baseline in Laboratory Tests Results
Measured: Baseline up to week 111
Number of Participants With Vital Sign Abnormalities
Measured: Baseline up to week 111
Secondary outcomes (4)
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters
Measured: Baseline up to week 111
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration
Measured: Baseline up to week 104
Minimum Observed Plasma Trough Concentration (Cmin), as data permits
Measured: Baseline up to week 111
Incidence of Anti-Drug Antibody (ADA)
Measured: Baseline up to week 111
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start10 Nov 2025
- Primary completion24 Aug 2028 (estimated)
- Study completion24 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073820
- Sponsor's protocol ID
- C5001004
- Other IDs
- 2025-521155-23-00, 2025
- Status last verified
- Aug 2026
- First submitted
- 9 Jul 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07073820
- Acronym / sponsor ID
- C5001004
- Conditions
- Pulmonary Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 24 Aug 2028 (estimated)
- Study completion
- 24 Aug 2028 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Drug: PF-07868489Participants will receive subcutaneous doses of PF-07868489 every 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-07868489Participants will receive subcutaneous doses of PF-07868489 every 4 weeks | Drug | Open Label |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to week 111
Number of Participants With Change From Baseline in Laboratory Tests Results
Time frame: Baseline up to week 111
Number of Participants With Vital Sign Abnormalities
Time frame: Baseline up to week 111
4 secondary outcomes
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame: Baseline up to week 111
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration
Time frame: Baseline up to week 104
Minimum Observed Plasma Trough Concentration (Cmin), as data permits
Time frame: Baseline up to week 111
Incidence of Anti-Drug Antibody (ADA)
Time frame: Baseline up to week 111
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
27 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-07868489 in people with Pulmonary Hypertension, run by Pfizer at 27 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Germany, United States, China, South Korea, Japan and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to week 111). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.