Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
455 participants
INTERVENTIONAL
2022-09-26
2025-03-05
Brief Summary
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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.
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Detailed Description
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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 to facilitate a more comprehensive assessment of PK characteristics and PK/PD relationship for GDF-15 in participants with heart failure and elevated circulating GDF-15 concentrations.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
In optional Cohort C, ponsegromab will be administered at low doses every 4 weeks by subcutaneous injections for a total of 6 doses. Participants will be randomized to the low dose of ponsegromab or placebo.
In optional Cohort D, ponsegromab will be administered at high doses every 4 weeks by subcutaneous injections for a total of 6 doses. Participants will be randomized to the high dose of ponsegromab or placebo.
In a separate open-label, PK cohort (Cohort B), 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.
SUPPORTIVE_CARE
QUADRUPLE
The separate PK cohort (Cohort B) 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 (Cohort B).
Study Groups
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Main cohort (Cohort A): ponsegromab low dose
Participants will receive a low dose Q4W SC
Main cohort (Cohort A): Ponsegromab low dose
Ponsegromab low dose subcutaneous injection
Main cohort (Cohort A): ponsegromab medium dose
Participants will receive a medium dose Q4W SC
Main cohort (Cohort A): Ponsegromab medium dose
Ponsegromab medium dose subcutaneous injection
Main cohort (Cohort A): ponsegromab high dose
Participants will receive a high dose Q4W SC
Main cohort (Cohort A): ponsegromab high dose
Ponsegromab high dose subcutaneous injection
Main cohort (Cohort A): placebo
matched placebo
Main cohort (Cohort A): Matched placebo
Matched placebo subcutaneous injection
Open-label, PK Cohort (Cohort B): ponsegromab low dose
Participants will receive a low dose Q4W SC
Open-label, PK Cohort (Cohort B): ponsegromab low dose
ponsegromab low dose subcutaneous injection
Open-label, PK Cohort (Cohort B): ponsegromab medium dose
Participants will receive a medium dose Q4W SC
Open-label, PK Cohort (Cohort B): ponsegromab medium dose
Ponsegromab medium dose subcutaneous injection
Open-label, PK Cohort (Cohort B): ponsegromab high dose
Participants will receive a high dose Q4W SC
Open-label, PK Cohort (Cohort B): ponsegromab high dose
Ponsegromab high dose subcutaneous injection
Optional Cohort C: ponsegromab low dose
Participants will receive a low dose Q4W SC
Optional Cohort C: Ponsegromab low dose
Ponsegromab low dose subcutaneous injection
Optional Cohort C: placebo
matched placebo
Optional Cohort C: Matched placebo
Matched placebo subcutaneous injection
Optional Cohort D: ponsegromab high dose
Participants will receive a high dose Q4W SC
Optional Cohort D: Ponsegromab high dose
Ponsegromab high dose subcutaneous injection
Optional Cohort D: placebo
matched placebo
Optional Cohort D: Matched placebo
Matched placebo subcutaneous injection
Interventions
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Main cohort (Cohort A): Ponsegromab low dose
Ponsegromab low dose subcutaneous injection
Main cohort (Cohort A): Ponsegromab medium dose
Ponsegromab medium dose subcutaneous injection
Main cohort (Cohort A): ponsegromab high dose
Ponsegromab high dose subcutaneous injection
Main cohort (Cohort A): Matched placebo
Matched placebo subcutaneous injection
Open-label, PK Cohort (Cohort B): ponsegromab low dose
ponsegromab low dose subcutaneous injection
Open-label, PK Cohort (Cohort B): ponsegromab medium dose
Ponsegromab medium dose subcutaneous injection
Open-label, PK Cohort (Cohort B): ponsegromab high dose
Ponsegromab high dose subcutaneous injection
Optional Cohort C: Ponsegromab low dose
Ponsegromab low dose subcutaneous injection
Optional Cohort C: Matched placebo
Matched placebo subcutaneous injection
Optional Cohort D: Ponsegromab high dose
Ponsegromab high dose subcutaneous injection
Optional Cohort D: Matched placebo
Matched placebo subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
-. Clinical evidence of HF with each of the following criteria:
1. 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).
2. NYHA class II-IV at screening.
3. NT-proBNP ≥400 pg/mL at screening (Note: Does not apply to open-label, PK Cohort \[Cohort B\]).
* Serum GDF-15 concentration ≥2000 pg/mL at screening.
* Cohort D only: Serum GDF-15 concentration \<2000 pg/mL at screening.
* KCCQ-23 CSS \<75 at screening (Note: Does not apply to open-label, PK Cohort \[Cohort B\]).
* Evidence of cachexia or fatigue or functional impairment, as demonstrated by at least one of the following at screening (Note: Does not apply to open-label, PK Cohort \[Cohort B\]):
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 based on the KCCQ-23 administered at screening; or
3. A score of \<60 on the Physical Limitations Domain of the KCCQ 23 administered at screening.
Exclusion Criteria
* 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 (Cohort B) 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 (Cohort B) 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).
18 Years
ALL
No
Sponsors
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The TIMI Study Group
OTHER
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Eastern shore Research Institute LLC
Fairhope, Alabama, United States
Keck Medical Center of USC
Los Angeles, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Emory University School of Medicine-Grady Campus
Atlanta, Georgia, United States
Chicago Medical Research
Hazel Crest, Illinois, United States
Reid Physician Associates
Richmond, Indiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Traverse Heart & Vascular
Traverse City, Michigan, United States
M Health Fairview Clinics and Surgery Center
Minneapolis, Minnesota, United States
M Health Fairview University of Minnesota Investigational Drug Services
Minneapolis, Minnesota, United States
M Health Fairview University of Minnesota Medical Center-East Bank
Minneapolis, Minnesota, United States
University of Minnesota/Lillehei Clinical Research Unit
Minneapolis, Minnesota, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Washington University in St. Louis Center for Outpatient Health (COH)
St Louis, Missouri, United States
Washington University in St. Louis Center for Advanced Medicine (CAM)
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Clinical and Translational Research Center
Chapel Hill, North Carolina, United States
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, United States
Texas Health Heart & Vascular Specialist (THHVS) #18760
Dallas, Texas, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Core Research Group
Brisbane, Queensland, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Fraser Clinical Trials Inc
New Westminster, British Columbia, Canada
QEII Health Sciences Centre - Victoria General Site
Halifax, Nova Scotia, Canada
Saul Vizel Professional Medicine Corporation dba Vizel Cardiac Research
Cambridge, Ontario, Canada
University Hospital - London Health Sciences Centre
London, Ontario, Canada
North York Diagnostic and Cardiac Centre
North York, Ontario, Canada
Private Practice - Dr. James Cha
Oshawa, Ontario, Canada
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, Canada
Corcare
Toronto, Ontario, Canada
Unity Health Toronto, St. Michael's Hospital
Toronto, Ontario, Canada
Community Care Building
Winchester, Ontario, Canada
Winchester District Memorial Hospital
Winchester, Ontario, Canada
Institut de Cardiologie de Montreal
Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski
Rimouski, Quebec, Canada
CardioVasc HR Inc
Saint-Jean-sur-Richelieu, Quebec, Canada
Centre intégré de santé et de services sociaux de Lanaudière - Hopital Pierre-Le Gardeur.
Terrebonne, Quebec, Canada
Diex Recherche Trois-Rivieres
Trois-Rivières, Quebec, Canada
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
China-Japan Union Hospital
Changchun, Jilin, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China
Tianjin People' s Hospital
Tianjin, Tianjin Municipality, China
Peking University First Hospital
Beijing, , China
EDUMED - Jaroměř
Jaroměř, Náchod, Czechia
Institut Klinicke a Experimentalni Mediciny
Prague, Praha 4, Czechia
Fakultni Nemocnice u sv. Anny v Brne
Brno, South Moravian, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Ustredni vojenska nemocnice
Prague, , Czechia
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt am Main, Hesse, Germany
Universitätsmedizin Göttingen - Georg-August-Universität
Göttingen, Lower Saxony, Germany
Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen
Bad Oeynhausen, North Rhine-Westphalia, Germany
Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien
Dresden, Saxony, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Pécsi Tudományegyetem Klinikai Központ
Pécs, Baranya, Hungary
Private Practice - Dr. Lakatos Ferenc
Békéscsaba, Bekes County, Hungary
TaNa Med
Mosonmagyaróvár, Győr-Moson-Sopron, Hungary
Medifarma 98 Kft
Nyíregyháza, Nyíregyháza, Hungary
Somogy Vármegyei Kaposi Mór Oktató Kórház
Kaposvár, Somogy County, Hungary
Dél-Pesti Centrumkórház Orszagos Hematologiai es Infektologiai Intezet
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Kanizsai Dorottya Korhaz
Nagykanizsa, , Hungary
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Hyōgo, Japan
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji, Hyōgo, Japan
Higashi Takarazuka Satoh Hospital
Takarazuka, Hyōgo, Japan
Iwate Prefectural Central Hospital
Morioka, Iwate, Japan
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, Japan
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, Japan
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan
National Hospital Organization Saitama Hospital
Wako, Saitama, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, Japan
Osaka General Medical Center
Osaka, , Japan
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Greater Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Lower Silesian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, Podlaskie Voivodeship, Poland
Kardio Brynow
Katowice, Silesian Voivodeship, Poland
Miejski Szpital Zespolony w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, Poland
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, , Poland
Polsko Amerykanskie Kliniki Serca
Tychy, , Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital Kliniczny
Warsaw, , Poland
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [LA Coruña], Spain
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña], Spain
Parc de Salut Mar - Hospital del Mar
Barcelona, Barcelona [barcelona], Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [cataluña], Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Comunidad de, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Región de, Spain
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, Spain
Hospital Universitario Virgen Nieves
Granada, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Wycombe General Hospital
High Wycombe, Buckinghamshire, United Kingdom
Ninewells Hospital and Medical School
Dundee, Dundee CITY, United Kingdom
St. George's Hospital
London, England and Wales, United Kingdom
Northwick Park Hospital
Harrow, London, CITY of, United Kingdom
Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom
Barnet Hospital
Barnet, , United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge, , United Kingdom
Golden Jubilee National Hospital
Clydebank, , United Kingdom
Lincoln County Hospital
Lincoln, , United Kingdom
Liverpool University Hospitals NHS Foundation Trust
Liverpool, , United Kingdom
Northern General Hospital
Sheffield, , United Kingdom
University Hospital of North Tees
Stockton-on-Tees, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2023-509747-27-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C3651011
Identifier Type: -
Identifier Source: org_study_id
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