Pulmonary Hypertension
Conditions
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.
Interventions
DRUGPF-07868489
Participants will receive subcutaneous doses of PF-07868489 every 4 weeks
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Change From Baseline in Laboratory Tests Results | Baseline up to week 111 |
| Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to week 111 |
| Number of Participants With Vital Sign Abnormalities | Baseline up to week 111 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Anti-Drug Antibody (ADA) | 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 |
| Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters | Baseline up to week 111 |
Countries
Australia, Belgium, China, Czechia, Germany, Japan, South Korea, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed