A PHASE 2, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-07868489 ADMINISTERED TO ADULT PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Pfizer
- Enrollment
- 42
- Locations
- 27
- Primary Endpoint
- Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Exclusion Criteria
- Not provided
Arms & Interventions
Open Label
Participants will receive subcutaneous doses of PF-07868489 every 4 weeks
Intervention: PF-07868489 (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)