Clinical trial • Phase II • Cardiology

PF-07868489 for Pulmonary arterial hypertension

Phase II trial of PF-07868489 for Pulmonary arterial hypertension. open-label. 17 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Pulmonary arterial hypertension
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
15-08-2025
First CTIS Authorization Date
02-12-2025

Trial design

open-label Phase II trial in Spain, Germany, Belgium and others.

Open Label
Yes
Target Sample Size
17
Trial Duration For Participant
728

Eligibility

Recruits 17 No vulnerable populations selected. Participants must be adults (18 years of age or older at screening of the qualifying study, or the minimum age of consent according to local regulations) and must be capable of giving signed informed consent as described in Appendix 1. No assent procedures for minors are described..

Vulnerable Population
No vulnerable populations selected. Participants must be adults (18 years of age or older at screening of the qualifying study, or the minimum age of consent according to local regulations) and must be capable of giving signed informed consent as described in Appendix 1. No assent procedures for minors are described.

Inclusion criteria

  • {"criterion_text":"- 18 years of age or older at screening of the qualifying (parent) study (or the minimum age of consent in accordance with local regulations), who have completed at least 20-week treatment period and week 24 study procedures of the qualifying study.\n- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n- Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol."}

Exclusion criteria

  • {"criterion_text":"- Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.\n- Participants who met discontinuation criteria at any point during the participating qualifying C5001001 study.\n- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.\n- Participants with clinical worsening or hospitalization for worsening PAH during the qualifying study, placement on a transplant list, and planned surgical procedure for PAH.\n- Participants with an ongoing clinically significant safety event in the qualifying parent study (C5001001 Part B) based on CTCAE Grade 3 or higher (Grade 4 for PAH-related) or in the opinion of the investigator that would preclude treatment with open label PF-07868489.\n- History or currently established hepato-pulmonary syndrome.\n- Use of any prohibited concomitant medication(s) during the qualifying or current study or unwillingness or inability to use a required concomitant medication(s) or change in stable background PAH medications used in the qualifying study. Refer to Section 6.9.\n- Current use of GLP-1 agonist.\n- Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.\n- Any of the following clinical chemistry values at baseline:  ALT or AST > 3× ULN (> 5 ULN if solely due to right heart failure) or total bilirubin ≥2 × ULN (For Gilbert’s syndrome, direct bilirubin >ULN [or ≥ 2 × ULN if solely due to right heart failure] is exclusionary).\n- Poor compliance with study visits or procedures during the qualifying C5001001 study, as assessed by the investigator or the Pfizer Medical Monitor."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Incidence and severity of treatment emergent Adverse Events (AEs) and Serious Adverse Events (SAEs).","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence of related treatment emergent AEs (TEAEs) & treatment emergent SAEs (TESAEs).","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in vital signs.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in clinical laboratory values.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in electrocardiogram (ECG) parameters (heart rate, QT, QTc corrected using Fridericia’s formula (QTcF), PR, and QRS intervals).","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Change from baseline in NT-pro-BNP.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- PF-07868489 PK parameters after repeat doses; as data permit: minimum plasma concentration (Cmin).","definition_or_measurement_approach":"Pharmacokinetic parameters to be measured after repeat subcutaneous doses; specifically minimum plasma concentration (Cmin) as data permit."}
  • {"endpoint_text":"- Incidence of the development of antidrug antibody (ADA) against PF-07868489 following repeat doses.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
17
Recruitment Window Months
40
Consent Approach
Signed informed consent must be provided by the participant. Participants must be capable of giving signed informed consent as described in Appendix 1. Eligibility requires participants to be 18 years of age or older at screening of the qualifying (parent) study (or the minimum age of consent in accordance with local regulations). Subject information and informed consent forms and related materials are provided in country/language-specific versions (documents listed for EN, ES, DE, FR, GR/EL, IT, NL, CS/CZ among others).

Geography

Total Number Of Sites
21
Total Number Of Participants
10

Spain

Earliest CTIS Part Ii Submission Date
07-11-2025
Latest Decision Or Authorization Date
11-12-2025
Processing Time Days
34
Number Of Sites
3
Number Of Participants
1

Sites

Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Pneumology Department
Principal Investigator Name
Jose Manuel Cifrián Martinez
Principal Investigator Email
josemanuel.cifrian@scsalud.es
Contact Person Name
Jose Manuel Cifrián Martinez
Contact Person Email
josemanuel.cifrian@scsalud.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Cardiology Department
Principal Investigator Name
Pilar Escribano Subias
Principal Investigator Email
pilar.escribano.subias@gmail.com
Contact Person Name
Pilar Escribano Subias
Site Name
Hospital Universitario La Paz
Department Name
Pulmonology Service
Principal Investigator Name
Sergio Alcolea Batres
Principal Investigator Email
alcobatres@yahoo.es
Contact Person Name
Sergio Alcolea Batres
Contact Person Email
alcobatres@yahoo.es

Germany

Earliest CTIS Part Ii Submission Date
10-11-2025
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
25
Number Of Sites
5
Number Of Participants
3

Sites

Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Centre for pulmonary hypertension
Principal Investigator Name
Ekkehard Grünig
Principal Investigator Email
Ekkehard.Gruenig@med.uni-heidelberg.de
Contact Person Name
Ekkehard Grünig
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik für Innere Medizin II
Principal Investigator Name
Stefan Stadler
Principal Investigator Email
stefan.stadler@ukr.de
Contact Person Name
Stefan Stadler
Contact Person Email
stefan.stadler@ukr.de
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I Abteilung für Pneumologie
Principal Investigator Name
Michael Halank
Principal Investigator Email
michael.halank@uniklinikum-dresden.de
Contact Person Name
Michael Halank
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
Medizinische Klinik und Poliklinik II
Principal Investigator Name
Hossein Ardeschir Ghofrani
Contact Person Name
Hossein Ardeschir Ghofrani
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Zentrum für Innere Medizin B Pneumologie/Infektiologie
Principal Investigator Name
Ralf Ewert
Principal Investigator Email
Ralf.Ewert@med.uni-greifswald.de
Contact Person Name
Ralf Ewert

Belgium

Earliest CTIS Part Ii Submission Date
04-11-2025
Latest Decision Or Authorization Date
18-12-2025
Processing Time Days
44
Number Of Sites
2
Number Of Participants
1

Sites

Site Name
UZ Leuven
Department Name
Intermediate Respiratory Care Unit
Principal Investigator Name
Marion Delcroix
Principal Investigator Email
marion.delcroix@uzleuven.be
Contact Person Name
Marion Delcroix
Contact Person Email
marion.delcroix@uzleuven.be
Site Name
Hopital Erasme
Department Name
Cardiology
Principal Investigator Name
Jean-Luc Vachiery
Principal Investigator Email
jean.luc.vachiery@hubruxelles.be
Contact Person Name
Jean-Luc Vachiery

Czechia

Earliest CTIS Part Ii Submission Date
23-10-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
40
Number Of Sites
2
Number Of Participants
1

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
II. interní klinika VFN a 1. LF UK
Principal Investigator Name
Pavel Jansa
Principal Investigator Email
pavel.jansa@vfn.cz
Contact Person Name
Pavel Jansa
Contact Person Email
pavel.jansa@vfn.cz
Site Name
Institute For Clinical And Experimental Medicine
Department Name
Klinika kardiologie
Principal Investigator Name
Hikmet Al-Hiti
Principal Investigator Email
hial@ikem.cz
Contact Person Name
Hikmet Al-Hiti
Contact Person Email
hial@ikem.cz

France

Earliest CTIS Part Ii Submission Date
21-11-2025
Latest Decision Or Authorization Date
19-12-2025
Processing Time Days
28
Number Of Sites
3
Number Of Participants
2

Sites

Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Service de Pneumologie Physiologie - CHUGA
Principal Investigator Name
Bruno Degano
Principal Investigator Email
bdegano@chu-grenoble.fr
Contact Person Name
Bruno Degano
Contact Person Email
bdegano@chu-grenoble.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Department of Internal Medicine and Pneumology
Principal Investigator Name
Cécile Tromeur
Principal Investigator Email
cecile.tromeur@chu-brest.fr
Contact Person Name
Cécile Tromeur
Contact Person Email
cecile.tromeur@chu-brest.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Service de Médecine Vasculaire et Thérapeutique
Principal Investigator Name
Laurent Bertoletti
Principal Investigator Email
laurent.bertoletti@chu-st-etienne.fr
Contact Person Name
Laurent Bertoletti

Italy

Earliest CTIS Part Ii Submission Date
17-10-2025
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
49
Number Of Sites
3
Number Of Participants
1

Sites

Site Name
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. I.S.M.E.T.T. S.r.l.
Department Name
Pulmonology Unit
Principal Investigator Name
Patrizio Vitulo
Principal Investigator Email
pvitulo@ismett.edu
Contact Person Name
Patrizio Vitulo
Contact Person Email
pvitulo@ismett.edu
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
U.O.C. Pneumologia
Principal Investigator Name
Giuseppe Paciocco
Principal Investigator Email
giuseppe.paciocco@unimib.it
Contact Person Name
Giuseppe Paciocco
Contact Person Email
giuseppe.paciocco@unimib.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
U.O di Cardiologia
Principal Investigator Name
Stefano Ghio
Principal Investigator Email
s.ghio@smatteo.pv.it
Contact Person Name
Stefano Ghio
Contact Person Email
s.ghio@smatteo.pv.it

Greece

Earliest CTIS Part Ii Submission Date
29-08-2025
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
115
Number Of Sites
3
Number Of Participants
1

Sites

Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Critical Care Department
Principal Investigator Name
Iraklis Tsagkaris
Principal Investigator Email
itsagkaris@med.uoa.gr
Contact Person Name
Iraklis Tsagkaris
Contact Person Email
itsagkaris@med.uoa.gr
Site Name
Onassis Cardiac Surgery Center
Department Name
Cardiology Department
Principal Investigator Name
Dimitrios Tsiapras
Principal Investigator Email
dtsiapras@hotmail.com
Contact Person Name
Dimitrios Tsiapras
Contact Person Email
dtsiapras@hotmail.com
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
1st Cardiology Clinic
Principal Investigator Name
George Giannakoulas
Principal Investigator Email
g.giannakoulas@gmail.com
Contact Person Name
George Giannakoulas
Contact Person Email
g.giannakoulas@gmail.com

Sponsor

Primary sponsor

Full Name
Pfizer Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Global Central Labs (S) Pte Ltd
Name
Ppd Laboratories (Suzhou) Co. Ltd.
Name
PPD International Holdings LLC
Name
Pharmaceutical Product Development LLC
Name
WCG Clinical Inc.
Responsibilities
clinical trial imaging services

Third parties

  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translations","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"clinical trial imaging services","organisation_type":"Pharmaceutical company"}
  • {"country":"Singapore","full_name":"PPD Global Central Labs (S) Pte Ltd","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Ppd Laboratories (Suzhou) Co. Ltd.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ancillare LP","duties_or_roles":"Non Drug Supplies","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Patient Reported Outcomes Data","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
PF-07868489
Active Substance
PF-07868489
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Investigational product
Orphan Designation
Yes

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