Heart Failure Clinical Trial

A Study of Ponsegromab in People With Heart Failure

Summary

The purpose of this clinical trial is to compare the effects of study medicine (Ponsegromab/PF-06946860) with a placebo (A pill 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 (a pill 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. All 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 the 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.

View Full Description

Full 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.

View Eligibility Criteria

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).

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

416

Study ID:

NCT05492500

Recruitment Status:

Recruiting

Sponsor:

Pfizer

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There are 125 Locations for this study

See Locations Near You

Eastern shore Research Institute LLC
Fairhope Alabama, 36532, United States
Keck Medical Center of USC
Los Angeles California, 90033, United States
MedStar Washington Hospital Center
Washington District of Columbia, 20010, United States
Cardiology Associates of Fort Lauderdale
Fort Lauderdale Florida, 33308, United States
Holy Cross Hospital/Jim Moran Heart & Vascular Research Institute
Fort Lauderdale Florida, 33308, United States
Holy Cross Hospital
Fort Lauderdale Florida, 33308, United States
Emory University School of Medicine-Grady Campus
Atlanta Georgia, 30303, United States
Chicago Medical Research
Hazel Crest Illinois, 60429, United States
Reid Physician Associates
Richmond Indiana, 47374, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Traverse Heart & Vascular
Traverse City Michigan, 49684, United States
M Health Fairview Clinics and Surgery Center
Minneapolis Minnesota, 55455, United States
M Health Fairview University of Minnesota Investigational Drug Services
Minneapolis Minnesota, 55455, United States
M Health Fairview University of Minnesota Medical Center-East Bank
Minneapolis Minnesota, 55455, United States
University of Minnesota/Lillehei Clinical Research Unit
Minneapolis Minnesota, 55455, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
Washington University in St. Louis Center for Outpatient Health (COH)
Saint Louis Missouri, 63108, United States
Washington University in St. Louis Center for Advanced Medicine (CAM)
Saint Louis Missouri, 63110, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Holy Name Medical Center
Teaneck New Jersey, 07666, United States
University of North Carolina Medical Center
Chapel Hill North Carolina, 27514, United States
Clinical and Translational Research Center
Chapel Hill North Carolina, 27599, United States
South Oklahoma Heart Research, LLC
Oklahoma City Oklahoma, 73135, United States
Texas Health Physicians Group
Dallas Texas, 75231, United States
Concord Repatriation General Hospital
Concord New South Wales, 2139, Australia
Core Research Group
Brisbane Queensland, 4064, Australia
The Prince Charles Hospital
Chermside Queensland, 4032, Australia
Gold Coast University Hospital
Southport Queensland, 4215, Australia
Lyell McEwin Hospital
Elizabeth Vale South Australia, 5112, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Fraser Clinical Trials Inc
New Westminster British Columbia, V3L 3, Canada
QEII Health Sciences Centre - Victoria General Site
Halifax Nova Scotia, B3H 3, Canada
Saul Vizel Professional Medicine Corporation dba Vizel Cardiac Research
Cambridge Ontario, N1R 7, Canada
University Hospital - London Health Sciences Centre
London Ontario, N6A 5, Canada
North York Diagnostic and Cardiac Centre
North York Ontario, M6B 3, Canada
Private Practice - Dr. James Cha
Oshawa Ontario, L1J 2, Canada
Kawartha Cardiology Clinical Trials
Peterborough Ontario, K9J 0, Canada
Corcare
Toronto Ontario, M1B 5, Canada
Unity Health Toronto, St. Michael's Hospital
Toronto Ontario, M5B 1, Canada
Winchester District Memorial Hospital
Winchester Ontario, K0C 2, Canada
Institut de Cardiologie de Montreal
Montreal Quebec, H1T 1, Canada
Centre Hospitalier de l'Université de Montréal
Montréal Quebec, H2X 3, Canada
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimousk
Rimouski Quebec, G5L 5, Canada
CardioVasc HR Inc
Saint-Jean-sur-Richelieu Quebec, J3A 1, Canada
Centre intégré de santé et de services sociaux de Lanaudière - Hopital Pierre-Le Gardeur.
Terrebonne Quebec, J6V 2, Canada
Diex Recherche Trois-Rivieres
Trois-Rivieres Quebec, G9A 4, Canada
Peking University First Hospital
Beijing Beijing, 10003, China
Guangdong Provincial People's Hospital
Guangzhou Guangdong, 51000, China
Guangdong Provincial People's Hospital
Guangzhou Guangdong, 51008, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou Guangdong, 51008, China
The Second Xiangya Hospital of Central South University
Changsha Hunan, 41001, China
The Second Xiangya Hospital of Central South University
Changsha Hunan, 41001, China
The First Affiliated Hospital of University of South China
Hengyang Hunan, 42100, China
China-Japan Union Hospital
Changchun Jilin, 13003, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an Shaanxi, 71006, China
Qilu Hospital of Shandong University
Jinan Shandong, 25001, China
Zhongshan Hospital,Fudan University
Shanghai Shanghai, 20003, China
Yuncheng Central Hospital
Yuncheng Shanxi, 04400, China
Tianjin People' s Hospital
Tianjin Tianjin, 30012, China
Tianjin People' s Hospital
Tianjin Tianjin, 30012, China
Peking University First Hospital
Beijing , 10003, China
Fakultni Nemocnice u sv. Anny v Brne
Brno Jihomoravský KRAJ, 602 0, Czechia
EDUMED - Jaroměř
Jaroměř Náchod, 551 0, Czechia
Institut Klinicke a Experimentalni Mediciny
Prague Praha 4, 140 2, Czechia
Fakultni nemocnice Kralovske Vinohrady
Praha 10 , 100 3, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2 , 12808, Czechia
Ustredni vojenska nemocnice
Praha 6 , 16902, Czechia
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt Hessen, 60590, Germany
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt Hessen, 60590, Germany
Universitätsmedizin Göttingen - Georg-August-Universität
Göttingen Niedersachsen, 37075, Germany
Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen
Bad Oeynhausen Nordrhein-westfalen, 32545, Germany
Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien
Dresden Sachsen, 01277, Germany
Universitätsklinikum Jena
Jena Thuringia, 7743, Germany
Universitätsklinikum Jena
Jena Thüringen, 07747, Germany
Pécsi Tudományegyetem Klinikai Központ
Pécs Baranya, 7624, Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemét Bács-kiskun, 6000, Hungary
Private Practice - Dr. Lakatos Ferenc
Békéscsaba Békés, 5600, Hungary
TaNa Med
Mosonmagyaróvár Győr-moson-sopron, 9200, Hungary
Medifarma 98 Kft
Nyiregyhaza Nyíregyháza, 4400, Hungary
Somogy Vármegyei Kaposi Mór Oktató Kórház
Kaposvár Somogy, 7400, Hungary
Budai Irgalmasrendi Korhaz
Budapest , 1023, Hungary
Dél-Pesti Centrumkórház Orszagos Hematologiai es Infektologiai Intezet
Budapest , 1097, Hungary
Semmelweis Egyetem
Budapest , 1122, Hungary
Kanizsai Dorottya Korhaz
Nagykanizsa , 8800, Hungary
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki Hyogo, 660-8, Japan
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji Hyogo, 670-8, Japan
Higashi Takarazuka Satoh Hospital
Takarazuka Hyogo, 665-0, Japan
Iwate Prefectural Central Hospital
Morioka Iwate, 020-0, Japan
National Hospital Organization Sendai Medical Center
Sendai Miyagi, 983-8, Japan
Kishiwada Tokushukai Hospital
Kishiwada Osaka, 596-0, Japan
Sakurabashi Watanabe Hospital
Osaka-shi Osaka, 530-0, Japan
National Cerebral and Cardiovascular Center
Suita Osaka, 564-8, Japan
National Cerebral and Cardiovascular Center
Suita Osaka, 564-8, Japan
Osaka General Medical Center
Sumiyoshi Ward Osaka, 558-8, Japan
National Hospital Organization Saitama Hospital
Wako Saitama, 351-0, Japan
Keio University Hospital
Shinjuku-ku Tokyo, 160-8, Japan
Saiseikai Kumamoto Hospital
Kumamoto , 861-4, Japan
Osaka General Medical Center
Osaka , 558-8, Japan
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wrocław Dolnośląskie, 50-55, Poland
Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy
Warszawa Mazowieckie, 04-62, Poland
Uniwersytecki Szpital Kliniczny w Białymstoku
Białystok Podlaskie, 15-27, Poland
Gabinet Kardiologiczno Internistyczny
Gdynia Pomorskie, 81-47, Poland
Miejski Szpital Zespolony w Olsztynie
Olsztyn Warmińsko-mazurskie, 10-04, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan Wielkopolskie, 61-84, Poland
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz , 92-21, Poland
Polsko Amerykanskie Kliniki Serca
Tychy , 43-10, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital Kliniczny
Warsaw , 02-09, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital Kliniczny
Warszawa , 02-09, Poland
Kardio Brynow
Katowice Śląskie, 40-55, Poland
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña A Coruña [LA Coruña], 15006, Spain
CHUS - Hospital Clinico Universitario
Santiago de Compostela A Coruña [LA Coruña], 15706, Spain
Parc de Salut Mar - Hospital del Mar
Barcelona Barcelona [barcelona], 08003, Spain
Hospital Universitari Vall d'Hebron
Barcelona Barcelona [barcelona], 08035, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat Barcelona, 08907, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona Catalunya [cataluña], 08041, Spain
Hospital Universitario Ramón y Cajal
Madrid Madrid, Comunidad DE, 28034, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda Madrid, Comunidad DE, 28222, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia Murcia, Región DE, 30120, Spain
Hospital Clinico de Valencia
Valencia Valenciana, Comunitat, 46010, Spain
Hospital Universitario Virgen Nieves
Granada , 18012, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Universitario Virgen de la Victoria
Málaga , 29010, Spain
Hospital Universitario Central de Asturias
Oviedo , 33011, Spain
Hospital Universitario Virgen Del Rocio
Sevilla , 41013, Spain
Hospital General Universitario de Valencia
Valencia , 46014, Spain
Hospital Universitari i Politecnic La Fe
Valencia , 46026, Spain
Wycombe General Hospital
High Wycombe Buckinghamshire, HP11 , United Kingdom
Ninewells Hospital and Medical School
Dundee Dundee CITY, DD1 9, United Kingdom
St. George's Hospital
London England AND Wales, SW17 , United Kingdom
Northwick Park Hospital
Harrow London, CITY OF, HA1 3, United Kingdom
Glasgow Royal Infirmary
Glasgow Scotland, G31 2, United Kingdom
Barnet Hospital
Barnet , EN5 3, United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge , CB2 0, United Kingdom
Golden Jubilee National Hospital
Clydebank , G81 4, United Kingdom
Lincoln County Hospital
Lincoln , LN2 5, United Kingdom
Liverpool University Hospitals NHS Foundation Trust
Liverpool , L9 7A, United Kingdom
Northern General Hospital
Sheffield , S5 7A, United Kingdom
University Hospital of North Tees
Stockton-On-Tees , TS19 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

416

Study ID:

NCT05492500

Recruitment Status:

Recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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