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A Study of Ponsegromab in People With Heart Failure (GARDEN TIMI 74)

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Main cohort: Ponsegromab low dose
Main cohort: Ponsegromab medium dose
Main cohort: ponsegromab high dose
Main cohort: Matched placebo
Open-label, PK Cohort: ponsegromab low dose
Open-label, PK Cohort: ponsegromab medium dose
Open-label, PK Cohort: ponsegromab high dose
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Heart Failure, N-terminal pro-B type natriuretic peptide, Kansas City Cardiomyopathy Questionnaire, Patient's Global Impression of Severity, Patient's Global Impression of Change, Patient Reported Outcome Measurement Information System, Growth differentiation factor 15, New York Heart Association

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female participants aged 18 years or older

    -. Clinical evidence of HF with each of the following criteria:

    1. LVEF <50% on most recent measurement (within the last 12 months).
    2. NYHA class II-IV at screening.
    3. NT-proBNP ≥400 pg/mL at screening.
  • Serum GDF-15 concentration ≥2000 pg/mL at screening.
  • KCCQ-23 CSS <75 at screening.

  • Evidence of cachexia or fatigue or functional impairment, as demonstrated by at least one of the following:

    1. Non-edematous unintentional weight loss ≥5% in the last 6 months or current BMI <20 kg/m2, associated with subjective fatigue or anorexia; or
    2. Fatigue at least 3 times per week AND at least moderately bothersome fatigue in the past 2 weeks; or
    3. A score of <60 on the Physical Limitations Domain of the KCCQ 23 administered at screening.

Exclusion Criteria:

  • Acute decompensated HF within 1 month prior to randomization.
  • Implantation of a cardiac resynchronization therapy device or valve repair or replacement within 3 months prior to randomization or intent to do so during the trial.
  • History of heart transplantation, currently listed for heart transplant, or planned mechanical circulatory support.
  • Acute coronary syndrome within 1 month prior to randomization.
  • Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) within 3 months prior to randomization or intent to undergo coronary revascularization during the trial.
  • Untreated indication for an implantable cardiac defibrillator or pacemaker to treat a cardiac rhythm abnormality (ie, tachyarrhythmia or bradyarrhythmia).
  • Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives (whichever is longer) preceding the first dose of study intervention used in this study. Treatment with an investigational biologic agent within 6 months or 5 half-lives (whichever is longer) of Day 1
  • Renal disease requiring dialysis.
  • Cirrhosis with evidence of portal hypertension not due to HF

Sites / Locations

  • Eastern shore Research Institute LLCRecruiting
  • Keck Medical Center of USCRecruiting
  • MedStar Washington Hospital CenterRecruiting
  • Cardiology Associates of Fort LauderdaleRecruiting
  • Holy Cross Hospital/Jim Moran Heart & Vascular Research InstituteRecruiting
  • Holy Cross HospitalRecruiting
  • Emory University School of Medicine-Grady CampusRecruiting
  • Chicago Medical ResearchRecruiting
  • Reid Physician AssociatesRecruiting
  • Brigham and Women's HospitalRecruiting
  • Henry Ford HospitalRecruiting
  • Traverse Heart & VascularRecruiting
  • M Health Fairview Clinics and Surgery Center
  • M Health Fairview University of Minnesota Investigational Drug Services
  • M Health Fairview University of Minnesota Medical Center-East Bank
  • University of Minnesota/Lillehei Clinical Research Unit
  • Saint Luke's Hospital of Kansas CityRecruiting
  • Washington University in St. Louis Center for Outpatient Health (COH)Recruiting
  • Washington University in St. Louis Center for Advanced Medicine (CAM)Recruiting
  • Washington University School of MedicineRecruiting
  • Holy Name Medical CenterRecruiting
  • University of North Carolina Medical CenterRecruiting
  • Clinical and Translational Research CenterRecruiting
  • South Oklahoma Heart Research, LLCRecruiting
  • Texas Health Physicians GroupRecruiting
  • Concord Repatriation General HospitalRecruiting
  • Core Research GroupRecruiting
  • The Prince Charles HospitalRecruiting
  • Gold Coast University HospitalRecruiting
  • Lyell McEwin Hospital
  • The Alfred HospitalRecruiting
  • Fraser Clinical Trials IncRecruiting
  • QEII Health Sciences Centre - Victoria General SiteRecruiting
  • Saul Vizel Professional Medicine Corporation dba Vizel Cardiac ResearchRecruiting
  • University Hospital - London Health Sciences CentreRecruiting
  • North York Diagnostic and Cardiac CentreRecruiting
  • Private Practice - Dr. James ChaRecruiting
  • Kawartha Cardiology Clinical TrialsRecruiting
  • CorcareRecruiting
  • Winchester District Memorial HospitalRecruiting
  • Centre Hospitalier de l'Université de MontréalRecruiting
  • Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de RimousRecruiting
  • CardioVasc HR IncRecruiting
  • Centre intégré de santé et de services sociaux de Lanaudière - Hopital Pierre-Le Gardeur.Recruiting
  • Diex Recherche Trois-RivieresRecruiting
  • Peking University First HospitalRecruiting
  • Guangdong Provincial People's Hospital
  • Guangdong Provincial People's HospitalRecruiting
  • The First Affiliated Hospital, Sun Yat-sen UniversityRecruiting
  • The Second Xiangya Hospital of Central South University
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • The First Affiliated Hospital of University of South ChinaRecruiting
  • China-Japan Union HospitalRecruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • Qilu Hospital of Shandong UniversityRecruiting
  • Zhongshan Hospital,Fudan UniversityRecruiting
  • Tianjin People' s HospitalRecruiting
  • Tianjin People' s Hospital
  • Peking University First HospitalRecruiting
  • Fakultni Nemocnice u sv. Anny v BrneRecruiting
  • EDUMED - JaroměřRecruiting
  • Institut Klinicke a Experimentalni MedicinyRecruiting
  • Fakultni nemocnice Kralovske VinohradyRecruiting
  • Ustredni vojenska nemocniceRecruiting
  • Pécsi Tudományegyetem Klinikai KözpontRecruiting
  • Bacs-Kiskun Varmegyei Oktatokorhaz
  • Private Practice - Dr. Lakatos FerencRecruiting
  • TaNa Med
  • Medifarma 98 KftRecruiting
  • Somogy Megyei Kaposi Mór Oktató KórházRecruiting
  • Budai Irgalmasrendi Korhaz
  • Dél-Pesti Centrumkórház Orszagos Hematologiai es Infektologiai Intezet
  • Semmelweis Egyetem
  • Kanizsai Dorottya Korhaz
  • Hyogo Prefectural Amagasaki General Medical CenterRecruiting
  • Hyogo Prefectural Harima-Himeji General Medical CenterRecruiting
  • Higashi Takarazuka Satoh HospitalRecruiting
  • Iwate Prefectural Central HospitalRecruiting
  • National Hospital Organization Sendai Medical CenterRecruiting
  • Kishiwada Tokushukai HospitalRecruiting
  • Sakurabashi Watanabe HospitalRecruiting
  • National Cerebral and Cardiovascular CenterRecruiting
  • National Cerebral and Cardiovascular Center
  • Osaka General Medical CenterRecruiting
  • National Hospital Organization Saitama HospitalRecruiting
  • Keio University HospitalRecruiting
  • Saiseikai Kumamoto HospitalRecruiting
  • Osaka General Medical CenterRecruiting
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
  • Gabinet Kardiologiczno Internistyczny
  • Uniwersytecki Szpital Kliniczny w PoznaniuRecruiting
  • Polsko Amerykanskie Kliniki SercaRecruiting
  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital KlinicznyRecruiting
  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital Kliniczny
  • Kardio Brynow
  • CHUS - Hospital Clinico UniversitarioRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Universitari de BellvitgeRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Universitario Puerta de Hierro MajadahondaRecruiting
  • Hospital Clínico Universitario Virgen de la ArrixacaRecruiting
  • Hospital Clinico de ValenciaRecruiting
  • Hospital Unviersitario Virgen NievesRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Universitario Virgen de la VictoriaRecruiting
  • Hospital Universitario Central de AsturiasRecruiting
  • Hospital General Universitario de ValenciaRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting
  • Wycombe General HospitalRecruiting
  • Ninewells Hospital and Medical SchoolRecruiting
  • St. George's HospitalRecruiting
  • Northwick Park HospitalRecruiting
  • Glasgow Royal InfirmaryRecruiting
  • Barnet HospitalRecruiting
  • Royal Papworth Hospital NHS Foundation Trust
  • Golden Jubilee National Hospital
  • Lincoln County HospitalRecruiting
  • Liverpool University Hospitals NHS Foundation TrustRecruiting
  • Northern General Hospital
  • University Hospital of North TeesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Main cohort: ponsegromab low dose

Main cohort: ponsegromab medium dose

Main cohort: ponsegromab high dose

Main cohort: placebo

Open-label, PK Cohort: ponsegromab low dose

Open-label, PK Cohort: ponsegromab medium dose

Open-label, PK Cohort: ponsegromab high dose

Arm Description

Participants will receive a low dose Q4W SC

Participants will receive a medium dose Q4W SC

Participants will receive a high dose Q4W SC

matched placebo

Participants will receive a low dose Q4W SC

Participants will receive a medium dose Q4W SC

Participants will receive a high dose Q4W SC

Outcomes

Primary Outcome Measures

Main cohort: Change from baseline in Kansas City Cardiomyopathy Questionnaire 23 Clinical Summary Score
To compare the effect of ponsegromab versus placebo, on heart failure disease-specific health status in participants with heart failure

Secondary Outcome Measures

Main cohort: Change from baseline in Kansas City Cardiomyopathy Questionnaire 23 Overall Summary Score
To compare the effect of ponsegromab versus placebo on HF disease-specific overall health status in participants with HF
Main cohort: Change from baseline in Kansas City Cardiomyopathy Questionnaire 23 Total Symptom Score
To compare the effect of ponsegromab versus placebo on HF disease-specific overall health status in participants with HF
Main cohort: Change from baseline in Kansas City Cardiomyopathy Questionnaire 23 physical limitations domain
To compare the effect of ponsegromab versus placebo on HF disease-specific overall health status in participants with HF
Main cohort: Responses as defined by a ≥5 point increase from baseline in Kansas City Cardiomyopathy Questionnaire 23 Clinical Summary Score
To compare the effect of ponsegromab versus placebo on HF disease-specific health status in participants with HF
Main cohort: Responses as defined by a ≥5 point increase from baseline in Overall Summary Score
To compare the effect of ponsegromab versus placebo on HF disease-specific health status in participants with HF
Main cohort: Responses as defined by a ≥5 point increase from baseline in Total Symptom Score
To compare the effect of ponsegromab versus placebo on HF disease-specific health status in participants with HF
Main cohort: Responses as defined by a ≥5 point increase from baseline in physical limitation
To compare the effect of ponsegromab versus placebo on HF disease-specific health status in participants with HF
Main cohort: Change from baseline in 6-Minute Walk Distance
To compare the effect of ponsegromab versus placebo on the physical function of participants with HF
Main cohort: Change from baseline in PROMIS-Fatigue 7a which will be completed by study participants on an electronic device, so as to compare the effect of ponsegromab versus placebo on fatigue as reported by participants with HF
To compare the effect of ponsegromab versus placebo on fatigue reported by participants with HF
Main cohort: Incidence of treatment-emergent adverse events
To describe the safety and tolerability of ponsegromab in participants with HF
Main cohort: Incidence of treatment-emergent serious adverse events
To describe the safety and tolerability of ponsegromab in participants with HF
Main cohort: Incidence of abnormal laboratory results
To describe the safety and tolerability of ponsegromab in participants with HF
Main cohort: Incidence of abnormal vital signs
To describe the safety and tolerability of ponsegromab in participants with HF
Open-Label, PK Cohort: Incidence of treatment-emergent adverse events
To describe the safety and tolerability of ponsegromab in participants with HF
Open-Label, PK Cohort: Incidence of treatment-emergent serious adverse events
To describe the safety and tolerability of ponsegromab in participants with HF
Open-Label, PK Cohort: Incidence of abnormal laboratory results
To describe the safety and tolerability of ponsegromab in participants with HF
Open-Label, PK Cohort: Incidence of abnormal vital signs
To describe the safety and tolerability of ponsegromab in participants with HF

Full Information

First Posted
July 25, 2022
Last Updated
October 10, 2023
Sponsor
Pfizer
Collaborators
Thrombolysis In Myocardial Infarction (TIMI)
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1. Study Identification

Unique Protocol Identification Number
NCT05492500
Brief Title
A Study of Ponsegromab in People With Heart Failure
Acronym
GARDEN TIMI 74
Official Title
A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, 4-ARM STUDY TO INVESTIGATE SYMPTOMS, FUNCTION, HEALTH-RELATED QUALITY OF LIFE AND SAFETY WITH REPEATED SUBCUTANEOUS ADMINISTRATION OF PONSEGROMAB VERSUS PLACEBO IN ADULT PARTICIPANTS WITH HEART FAILURE
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
June 7, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Thrombolysis In Myocardial Infarction (TIMI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary purpose of this clinical trial is to compare the effects of study medicine (Ponsegromab/PF-06946860) with a placebo (an injection that looks like the study medicine but does not contain the active medicine) to find out if the study medicine is better than the placebo (an injection that looks like the study medicine but does not contain the active medicine) for treatment of symptoms related to heart failure. Participants will not know which treatment group they are assigned to. Most participants in this study will receive the study medicine or placebo by shots under the skin every four weeks. People may be able to participate in this study if they have heart failure. Participants will take part in this study for about 9 months. During this time participants will visit the study clinic once a month. A separate PK cohort within this clinical trial will receive open-label study medicine (Ponsegromab/PF-06946860) only. Participants in this open-label, PK cohort will not receive placebo. These participants will receive the study medicine by shots under the skin every four weeks. People may be able to participate in this study cohort if they also have heart failure. Participants will take part in the open-label, PK cohort for about 7 months.
Detailed Description
The primary purpose of this study is to assess the effect of repeated subcutaneous administration of ponsegromab (PF-06946860) compared to placebo on frequency, severity, and burden of symptoms as well as physical limitations in participants with heart failure and elevated circulating GDF-15 concentrations. The study will also assess the safety, tolerability, PK, PD, and immunogenicity of ponsegromab. A separate, open-label, PK cohort, with more frequent PK and GDF-15 collection after single and multiple subcutaneous administration of ponsegromab (PF-06946860), will be enrolled at certain sites in the United States and Canada to facilitate a more comprehensive assessment of PK characteristics and PK/PD relationship for GDF-15 in participants with heart failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, N-terminal pro-B type natriuretic peptide, Kansas City Cardiomyopathy Questionnaire, Patient's Global Impression of Severity, Patient's Global Impression of Change, Patient Reported Outcome Measurement Information System, Growth differentiation factor 15, New York Heart Association

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
In the main cohort, ponsegromab will be administered at low, medium and high doses every 4 weeks by subcutaneous injections for a total of 6 doses. Participants will be randomized to 1 of the 3 doses of ponsegromab or placebo. In a separate open-label, PK cohort, ponsegromab will be administered at low, medium and high doses every 4 weeks by subcutaneous injections for a total of 4 doses. Participants will be randomized to 1 of the 3 doses of ponsegromab. There is no placebo in the open-label, PK cohort.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
In the main cohort, investigators, sponsor, participants and other site staff will be blinded to participants' assigned study intervention, including the site staff assigned to prepare and administer the study intervention. Pharmacists and site personnel will be blinded to study intervention versus placebo within each study arm. The separate PK cohort will be open-label and study treatment will be prepared and administered as per treatment assignment by qualified personnel. There is no blinding in the open-label, PK cohort.
Allocation
Randomized
Enrollment
436 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Main cohort: ponsegromab low dose
Arm Type
Experimental
Arm Description
Participants will receive a low dose Q4W SC
Arm Title
Main cohort: ponsegromab medium dose
Arm Type
Experimental
Arm Description
Participants will receive a medium dose Q4W SC
Arm Title
Main cohort: ponsegromab high dose
Arm Type
Experimental
Arm Description
Participants will receive a high dose Q4W SC
Arm Title
Main cohort: placebo
Arm Type
Placebo Comparator
Arm Description
matched placebo
Arm Title
Open-label, PK Cohort: ponsegromab low dose
Arm Type
Experimental
Arm Description
Participants will receive a low dose Q4W SC
Arm Title
Open-label, PK Cohort: ponsegromab medium dose
Arm Type
Experimental
Arm Description
Participants will receive a medium dose Q4W SC
Arm Title
Open-label, PK Cohort: ponsegromab high dose
Arm Type
Experimental
Arm Description
Participants will receive a high dose Q4W SC
Intervention Type
Drug
Intervention Name(s)
Main cohort: Ponsegromab low dose
Other Intervention Name(s)
PF-06946860 low dose
Intervention Description
Ponsegromab low dose subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Main cohort: Ponsegromab medium dose
Other Intervention Name(s)
PF-06946860 medium dose
Intervention Description
Ponsegromab medium dose subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Main cohort: ponsegromab high dose
Other Intervention Name(s)
PF-06946860 high dose
Intervention Description
Ponsegromab high dose subcutaneous injection
Intervention Type
Other
Intervention Name(s)
Main cohort: Matched placebo
Other Intervention Name(s)
Placebo
Intervention Description
Matched placebo subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Open-label, PK Cohort: ponsegromab low dose
Other Intervention Name(s)
PF-06946860 low dose
Intervention Description
ponsegromab low dose subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Open-label, PK Cohort: ponsegromab medium dose
Other Intervention Name(s)
PF-06946860 medium dose
Intervention Description
Ponsegromab medium dose subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Open-label, PK Cohort: ponsegromab high dose
Other Intervention Name(s)
PF-06946860 high dose
Intervention Description
Ponsegromab high dose subcutaneous injection
Primary Outcome Measure Information:
Title
Main cohort: Change from baseline in Kansas City Cardiomyopathy Questionnaire 23 Clinical Summary Score
Description
To compare the effect of ponsegromab versus placebo, on heart failure disease-specific health status in participants with heart failure
Time Frame
baseline, 22 weeks
Secondary Outcome Measure Information:
Title
Main cohort: Change from baseline in Kansas City Cardiomyopathy Questionnaire 23 Overall Summary Score
Description
To compare the effect of ponsegromab versus placebo on HF disease-specific overall health status in participants with HF
Time Frame
baseline, 22 weeks
Title
Main cohort: Change from baseline in Kansas City Cardiomyopathy Questionnaire 23 Total Symptom Score
Description
To compare the effect of ponsegromab versus placebo on HF disease-specific overall health status in participants with HF
Time Frame
baseline, 22 weeks
Title
Main cohort: Change from baseline in Kansas City Cardiomyopathy Questionnaire 23 physical limitations domain
Description
To compare the effect of ponsegromab versus placebo on HF disease-specific overall health status in participants with HF
Time Frame
baseline, 22 weeks
Title
Main cohort: Responses as defined by a ≥5 point increase from baseline in Kansas City Cardiomyopathy Questionnaire 23 Clinical Summary Score
Description
To compare the effect of ponsegromab versus placebo on HF disease-specific health status in participants with HF
Time Frame
baseline, 22 weeks
Title
Main cohort: Responses as defined by a ≥5 point increase from baseline in Overall Summary Score
Description
To compare the effect of ponsegromab versus placebo on HF disease-specific health status in participants with HF
Time Frame
baseline, 22 weeks
Title
Main cohort: Responses as defined by a ≥5 point increase from baseline in Total Symptom Score
Description
To compare the effect of ponsegromab versus placebo on HF disease-specific health status in participants with HF
Time Frame
baseline, 22 weeks
Title
Main cohort: Responses as defined by a ≥5 point increase from baseline in physical limitation
Description
To compare the effect of ponsegromab versus placebo on HF disease-specific health status in participants with HF
Time Frame
baseline, 22 weeks
Title
Main cohort: Change from baseline in 6-Minute Walk Distance
Description
To compare the effect of ponsegromab versus placebo on the physical function of participants with HF
Time Frame
baseline, 22 weeks
Title
Main cohort: Change from baseline in PROMIS-Fatigue 7a which will be completed by study participants on an electronic device, so as to compare the effect of ponsegromab versus placebo on fatigue as reported by participants with HF
Description
To compare the effect of ponsegromab versus placebo on fatigue reported by participants with HF
Time Frame
baseline, 22 weeks
Title
Main cohort: Incidence of treatment-emergent adverse events
Description
To describe the safety and tolerability of ponsegromab in participants with HF
Time Frame
32 weeks
Title
Main cohort: Incidence of treatment-emergent serious adverse events
Description
To describe the safety and tolerability of ponsegromab in participants with HF
Time Frame
32 weeks
Title
Main cohort: Incidence of abnormal laboratory results
Description
To describe the safety and tolerability of ponsegromab in participants with HF
Time Frame
32 weeks
Title
Main cohort: Incidence of abnormal vital signs
Description
To describe the safety and tolerability of ponsegromab in participants with HF
Time Frame
32 weeks
Title
Open-Label, PK Cohort: Incidence of treatment-emergent adverse events
Description
To describe the safety and tolerability of ponsegromab in participants with HF
Time Frame
22 weeks
Title
Open-Label, PK Cohort: Incidence of treatment-emergent serious adverse events
Description
To describe the safety and tolerability of ponsegromab in participants with HF
Time Frame
22 weeks
Title
Open-Label, PK Cohort: Incidence of abnormal laboratory results
Description
To describe the safety and tolerability of ponsegromab in participants with HF
Time Frame
22 weeks
Title
Open-Label, PK Cohort: Incidence of abnormal vital signs
Description
To describe the safety and tolerability of ponsegromab in participants with HF
Time Frame
22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female participants aged 18 years or older -. Clinical evidence of HF with each of the following criteria: LVEF <50% on most recent measurement, within 12 months of screening. Note: An assessment of LVEF in the prior 12 months is not required in situations where LVEF has been persistently <50% on prior assessments obtained at least 3 months apart (including the most recent measurement). NYHA class II-IV at screening. Main cohort only: NT-proBNP ≥400 pg/mL at screening. Serum GDF-15 concentration ≥2000 pg/mL at screening. Main cohort only: KCCQ-23 CSS <75 at screening. Main cohort only: Evidence of cachexia or fatigue or functional impairment, as demonstrated by at least one of the following at screening: Non-edematous unintentional weight loss ≥5% in the last 6 months or current BMI <20 kg/m2, associated with subjective fatigue or anorexia; or Fatigue at least 3 times per week AND at least moderately bothersome fatigue in the past 2 weeks based on the KCCQ-23 administered at screening; or A score of <60 on the Physical Limitations Domain of the KCCQ 23 administered at screening. Exclusion Criteria: Acute decompensated HF within 1 month prior to Screening Visit 1 or during the screening period. Implantation of a cardiac resynchronization therapy device or valve repair or replacement within 3 months prior to randomization or intent to do so during the trial. For the open-label, PK cohort only: implantation of a cardiac resynchronization therapy device more than 1 month prior to randomization is permitted. History of heart transplantation, currently listed for heart transplant, current/planned mechanical circulatory support, or current/planned use of intravenous inotropes (eg, dobutamine, milrinone). Acute coronary syndrome within 1 month prior to randomization. Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) within 3 months prior to randomization or intent to undergo coronary revascularization during the trial. For the open-label, PK cohort only: coronary revascularization more than 1 month prior to randomization is permitted. Untreated indication for an implantable cardiac defibrillator or pacemaker to treat a cardiac rhythm abnormality (ie, tachyarrhythmia or bradyarrhythmia). Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives (whichever is longer) preceding the first dose of study intervention used in this study. Treatment with an investigational biologic agent within 6 months or 5 half-lives (whichever is longer) of Day 1. Previous exposure to ponsegromab in a prior clinical study. Renal disease requiring ongoing dialysis. Cirrhosis with evidence of portal hypertension not due to HF, or the following LFT abnormalities at the time of screening, confirmed by a repeat test if deemed necessary: AST or ALT level ≥ 3 x ULN, or total bilirubin level ≥ 2 x ULN (unless history of Gilbert's syndrome).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Eastern shore Research Institute LLC
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Individual Site Status
Recruiting
Facility Name
Keck Medical Center of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Cardiology Associates of Fort Lauderdale
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Name
Holy Cross Hospital/Jim Moran Heart & Vascular Research Institute
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University School of Medicine-Grady Campus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Name
Chicago Medical Research
City
Hazel Crest
State/Province
Illinois
ZIP/Postal Code
60429
Country
United States
Individual Site Status
Recruiting
Facility Name
Reid Physician Associates
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Individual Site Status
Recruiting
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Traverse Heart & Vascular
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Individual Site Status
Recruiting
Facility Name
M Health Fairview Clinics and Surgery Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
M Health Fairview University of Minnesota Investigational Drug Services
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
M Health Fairview University of Minnesota Medical Center-East Bank
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Minnesota/Lillehei Clinical Research Unit
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University in St. Louis Center for Outpatient Health (COH)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University in St. Louis Center for Advanced Medicine (CAM)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Individual Site Status
Recruiting
Facility Name
University of North Carolina Medical Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical and Translational Research Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7064
Country
United States
Individual Site Status
Recruiting
Facility Name
South Oklahoma Heart Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Health Physicians Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Individual Site Status
Recruiting
Facility Name
Core Research Group
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Recruiting
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Recruiting
Facility Name
Lyell McEwin Hospital
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Fraser Clinical Trials Inc
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W4
Country
Canada
Individual Site Status
Recruiting
Facility Name
QEII Health Sciences Centre - Victoria General Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Saul Vizel Professional Medicine Corporation dba Vizel Cardiac Research
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 7R1
Country
Canada
Individual Site Status
Recruiting
Facility Name
University Hospital - London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Individual Site Status
Recruiting
Facility Name
North York Diagnostic and Cardiac Centre
City
North York
State/Province
Ontario
ZIP/Postal Code
M6B 3H7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Private Practice - Dr. James Cha
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1J 2K1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Kawartha Cardiology Clinical Trials
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 0B2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Corcare
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M1B 5N1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Winchester District Memorial Hospital
City
Winchester
State/Province
Ontario
ZIP/Postal Code
K0C 2K0
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimous
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Individual Site Status
Recruiting
Facility Name
CardioVasc HR Inc
City
Saint-Jean-sur-Richelieu
State/Province
Quebec
ZIP/Postal Code
J3A 1J2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre intégré de santé et de services sociaux de Lanaudière - Hopital Pierre-Le Gardeur.
City
Terrebonne
State/Province
Quebec
ZIP/Postal Code
J6V 2H2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Diex Recherche Trois-Rivieres
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G9A 4P3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of University of South China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
Individual Site Status
Recruiting
Facility Name
China-Japan Union Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130033
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongshan Hospital,Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin People' s Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300120
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin People' s Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300121
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Fakultni Nemocnice u sv. Anny v Brne
City
Brno
State/Province
Jihomoravský KRAJ
ZIP/Postal Code
602 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
EDUMED - Jaroměř
City
Jaroměř
State/Province
Náchod
ZIP/Postal Code
551 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Institut Klinicke a Experimentalni Mediciny
City
Prague
State/Province
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Ustredni vojenska nemocnice
City
Praha 6
ZIP/Postal Code
16902
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Pécsi Tudományegyetem Klinikai Központ
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7624
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Bacs-Kiskun Varmegyei Oktatokorhaz
City
Kecskemét
State/Province
Bács-kiskun
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Private Practice - Dr. Lakatos Ferenc
City
Békéscsaba
State/Province
Békés
ZIP/Postal Code
5600
Country
Hungary
Individual Site Status
Recruiting
Facility Name
TaNa Med
City
Mosonmagyaróvár
State/Province
Győr-moson-sopron
ZIP/Postal Code
9200
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Medifarma 98 Kft
City
Nyiregyhaza
State/Province
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Budai Irgalmasrendi Korhaz
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Dél-Pesti Centrumkórház Orszagos Hematologiai es Infektologiai Intezet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Kanizsai Dorottya Korhaz
City
Nagykanizsa
ZIP/Postal Code
8800
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Hyogo Prefectural Amagasaki General Medical Center
City
Amagasaki
State/Province
Hyogo
ZIP/Postal Code
660-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hyogo Prefectural Harima-Himeji General Medical Center
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
670-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Higashi Takarazuka Satoh Hospital
City
Takarazuka
State/Province
Hyogo
ZIP/Postal Code
665-0873
Country
Japan
Individual Site Status
Recruiting
Facility Name
Iwate Prefectural Central Hospital
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-0066
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Sendai Medical Center
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
983-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kishiwada Tokushukai Hospital
City
Kishiwada
State/Province
Osaka
ZIP/Postal Code
596-0042
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sakurabashi Watanabe Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cerebral and Cardiovascular Center
City
Suita
State/Province
Osaka
ZIP/Postal Code
564-8565
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cerebral and Cardiovascular Center
City
Suita
State/Province
Osaka
ZIP/Postal Code
564-8565
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Osaka General Medical Center
City
Sumiyoshi Ward
State/Province
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Saitama Hospital
City
Wako
State/Province
Saitama
ZIP/Postal Code
351-0102
Country
Japan
Individual Site Status
Recruiting
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-4193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Gabinet Kardiologiczno Internistyczny
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-472
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Poznaniu
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-848
Country
Poland
Individual Site Status
Recruiting
Facility Name
Polsko Amerykanskie Kliniki Serca
City
Tychy
ZIP/Postal Code
43-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital Kliniczny
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital Kliniczny
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Kardio Brynow
City
Katowice
State/Province
Śląskie
ZIP/Postal Code
40-555
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
CHUS - Hospital Clinico Universitario
City
Santiago de Compostela
State/Province
A Coruña [LA Coruña]
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
State/Province
Catalunya [cataluña]
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
State/Province
Madrid, Comunidad DE
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid, Comunidad DE
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
El Palmar, Murcia
State/Province
Murcia, Región DE
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico de Valencia
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Unviersitario Virgen Nieves
City
Granada
ZIP/Postal Code
18012
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Wycombe General Hospital
City
High Wycombe
State/Province
Buckinghamshire
ZIP/Postal Code
HP11 2TT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Ninewells Hospital and Medical School
City
Dundee
State/Province
Dundee CITY
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
St. George's Hospital
City
London
State/Province
England AND Wales
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Northwick Park Hospital
City
Harrow
State/Province
London, CITY OF
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Glasgow Royal Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G31 2ER
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Barnet Hospital
City
Barnet
ZIP/Postal Code
EN5 3DJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Papworth Hospital NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0AY
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Golden Jubilee National Hospital
City
Clydebank
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Lincoln County Hospital
City
Lincoln
ZIP/Postal Code
LN2 5QY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Liverpool University Hospitals NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Northern General Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
University Hospital of North Tees
City
Stockton-On-Tees
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3651011
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study of Ponsegromab in People With Heart Failure

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