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

April 10, 2024 updated by: Pfizer

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

416

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Recruiting
        • Concord Repatriation General Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4064
        • Recruiting
        • Core Research Group
      • Chermside, Queensland, Australia, 4032
        • Recruiting
        • The Prince Charles Hospital
      • Southport, Queensland, Australia, 4215
        • Recruiting
        • Gold Coast University Hospital
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Recruiting
        • Lyell McEwin Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Recruiting
        • Fraser Clinical Trials Inc
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Recruiting
        • QEII Health Sciences Centre - Victoria General Site
    • Ontario
      • Cambridge, Ontario, Canada, N1R 7R1
        • Recruiting
        • Saul Vizel Professional Medicine Corporation dba Vizel Cardiac Research
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • University Hospital - London Health Sciences Centre
      • North York, Ontario, Canada, M6B 3H7
        • Recruiting
        • North York Diagnostic and Cardiac Centre
      • Oshawa, Ontario, Canada, L1J 2K1
        • Recruiting
        • Private Practice - Dr. James Cha
      • Peterborough, Ontario, Canada, K9J 0B2
        • Recruiting
        • Kawartha Cardiology Clinical Trials
      • Toronto, Ontario, Canada, M5B 1W8
        • Not yet recruiting
        • Unity Health Toronto, St. Michael's Hospital
      • Toronto, Ontario, Canada, M1B 5N1
        • Recruiting
        • Corcare
      • Winchester, Ontario, Canada, K0C 2K0
        • Recruiting
        • Winchester District Memorial Hospital
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Recruiting
        • Institut de Cardiologie de Montreal
      • Montréal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal
      • Rimouski, Quebec, Canada, G5L 5T1
        • Recruiting
        • Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimousk
      • Saint-Jean-sur-Richelieu, Quebec, Canada, J3A 1J2
        • Active, not recruiting
        • CardioVasc HR Inc
      • Terrebonne, Quebec, Canada, J6V 2H2
        • Recruiting
        • Centre intégré de santé et de services sociaux de Lanaudière - Hopital Pierre-Le Gardeur.
      • Trois-Rivieres, Quebec, Canada, G9A 4P3
        • Recruiting
        • Diex Recherche Trois-Rivieres
  • China
      • Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • Guangdong Provincial People's Hospital
    • Hunan
      • Changsha, Hunan, China, 410011
        • Not yet recruiting
        • The Second Xiangya Hospital of Central South University
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
      • Hengyang, Hunan, China, 421001
        • Recruiting
        • The First Affiliated Hospital of University of South China
    • Jilin
      • Changchun, Jilin, China, 130033
        • Recruiting
        • China-Japan Union Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Shandong
      • Jinan, Shandong, China, 250014
        • Recruiting
        • Qilu Hospital of Shandong University
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital,Fudan University
    • Shanxi
      • Yuncheng, Shanxi, China, 044000
        • Recruiting
        • Yuncheng Central Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300121
        • Not yet recruiting
        • Tianjin People' s Hospital
      • Tianjin, Tianjin, China, 300120
        • Recruiting
        • Tianjin People' s Hospital
  • Czechia
      • Praha 10, Czechia, 100 34
        • Recruiting
        • Fakultni nemocnice Kralovske Vinohrady
      • Praha 2, Czechia, 12808
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze
      • Praha 6, Czechia, 16902
        • Recruiting
        • Ustredni vojenska nemocnice
    • Jihomoravský KRAJ
      • Brno, Jihomoravský KRAJ, Czechia, 602 00
        • Recruiting
        • Fakultni Nemocnice u sv. Anny v Brne
    • Náchod
      • Jaroměř, Náchod, Czechia, 551 01
        • Recruiting
        • EDUMED - Jaroměř
    • Praha 4
      • Prague, Praha 4, Czechia, 140 21
        • Recruiting
        • Institut klinické a experimentální medicíny
  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Not yet recruiting
        • Universitätsklinikum Frankfurt Goethe-Universität
    • Niedersachsen
      • Göttingen, Niedersachsen, Germany, 37075
        • Recruiting
        • Universitätsmedizin Göttingen - Georg-August-Universität
    • Nordrhein-westfalen
      • Bad Oeynhausen, Nordrhein-westfalen, Germany, 32545
        • Not yet recruiting
        • Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen
    • Sachsen
      • Dresden, Sachsen, Germany, 01277
        • Recruiting
        • Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien
    • Thuringia
      • Jena, Thuringia, Germany, 7743
        • Not yet recruiting
        • Universitätsklinikum Jena
    • Thüringen
      • Jena, Thüringen, Germany, 07747
        • Not yet recruiting
        • Universitätsklinikum Jena
  • Hungary
      • Budapest, Hungary, 1023
        • Recruiting
        • Budai Irgalmasrendi Korhaz
      • Budapest, Hungary, 1097
        • Recruiting
        • Del-pesti Centrumkorhaz Orszagos Hematologiai és Infektologiai Intezet
      • Budapest, Hungary, 1122
        • Recruiting
        • Semmelweis Egyetem
      • Nagykanizsa, Hungary, 8800
        • Recruiting
        • Kanizsai Dorottya Korhaz
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Recruiting
        • Pecsi Tudomanyegyetem Klinikai Kozpont
    • Bács-kiskun
      • Kecskemét, Bács-kiskun, Hungary, 6000
        • Recruiting
        • Bacs-Kiskun Varmegyei Oktatokorhaz
    • Békés
      • Békéscsaba, Békés, Hungary, 5600
        • Recruiting
        • Private Practice - Dr. Lakatos Ferenc
    • Győr-moson-sopron
      • Mosonmagyaróvár, Győr-moson-sopron, Hungary, 9200
        • Recruiting
        • TaNa Med
    • Nyíregyháza
      • Nyiregyhaza, Nyíregyháza, Hungary, 4400
        • Recruiting
        • Medifarma 98 Kft
    • Somogy
      • Kaposvár, Somogy, Hungary, 7400
        • Recruiting
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz
  • Japan
      • Kumamoto, Japan, 861-4193
        • Recruiting
        • Saiseikai Kumamoto Hospital
      • Osaka, Japan, 558-8558
        • Recruiting
        • Osaka General Medical Center
    • Hyogo
      • Amagasaki, Hyogo, Japan, 660-8550
        • Recruiting
        • Hyogo Prefectural Amagasaki General Medical Center
      • Himeji, Hyogo, Japan, 670-8560
        • Recruiting
        • Hyogo Prefectural Harima-Himeji General Medical Center
      • Takarazuka, Hyogo, Japan, 665-0873
        • Recruiting
        • Higashi Takarazuka Satoh Hospital
    • Iwate
      • Morioka, Iwate, Japan, 020-0066
        • Recruiting
        • Iwate Prefectural Central Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 983-8520
        • Recruiting
        • National Hospital Organization Sendai Medical Center
    • Osaka
      • Kishiwada, Osaka, Japan, 596-0042
        • Recruiting
        • Kishiwada Tokushukai Hospital
      • Osaka-shi, Osaka, Japan, 530-0001
        • Recruiting
        • Sakurabashi Watanabe Hospital
      • Suita, Osaka, Japan, 564-8565
        • Recruiting
        • National Cerebral and Cardiovascular Center
      • Suita, Osaka, Japan, 564-8565
        • Not yet recruiting
        • National Cerebral and Cardiovascular Center
      • Sumiyoshi Ward, Osaka, Japan, 558-8558
        • Recruiting
        • Osaka General Medical Center
    • Saitama
      • Wako, Saitama, Japan, 351-0102
        • Recruiting
        • National Hospital Organization Saitama Hospital
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Recruiting
        • Keio University Hospital
  • Poland
      • Lodz, Poland, 92-213
        • Recruiting
        • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
      • Tychy, Poland, 43-100
        • Recruiting
        • Polsko Amerykanskie Kliniki Serca
      • Warsaw, Poland, 02-097
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital Kliniczny
      • Warszawa, Poland, 02-097
        • Not yet recruiting
        • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital Kliniczny
    • Dolnośląskie
      • Wrocław, Dolnośląskie, Poland, 50-556
        • Recruiting
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 04-628
        • Recruiting
        • Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy
    • Pomorskie
      • Gdynia, Pomorskie, Poland, 81-472
        • Not yet recruiting
        • Gabinet Kardiologiczno Internistyczny
    • Warmińsko-mazurskie
      • Olsztyn, Warmińsko-mazurskie, Poland, 10-045
        • Recruiting
        • Miejski Szpital Zespolony w Olsztynie
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 61-848
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Poznaniu
    • Śląskie
      • Katowice, Śląskie, Poland, 40-555
        • Recruiting
        • Kardio Brynow
  • Spain
      • Granada, Spain, 18012
        • Recruiting
        • Hospital Universitario Virgen Nieves
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
      • Oviedo, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen Del Rocio
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari I Politecnic La Fe
      • Valencia, Spain, 46014
        • Recruiting
        • Hospital General Universitario de Valencia
    • A Coruña [LA Coruña]
      • A Coruña, A Coruña [LA Coruña], Spain, 15006
        • Recruiting
        • CHUAC-Complejo Hospitalario Universitario A Coruña
      • Santiago de Compostela, A Coruña [LA Coruña], Spain, 15706
        • Recruiting
        • CHUS - Hospital Clinico Universitario
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge
    • Barcelona [barcelona]
      • Barcelona, Barcelona [barcelona], Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Barcelona [barcelona], Spain, 08003
        • Recruiting
        • Parc de Salut Mar - Hospital del Mar
    • Catalunya [cataluña]
      • Barcelona, Catalunya [cataluña], Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
    • Madrid, Comunidad DE
      • Madrid, Madrid, Comunidad DE, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon Y Cajal
      • Majadahonda, Madrid, Comunidad DE, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
    • Murcia, Región DE
      • El Palmar, Murcia, Murcia, Región DE, Spain, 30120
        • Recruiting
        • Hospital Clínico Universitario Virgen de la Arrixaca
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Recruiting
        • Hospital Clinico de Valencia
  • United Kingdom
      • Barnet, United Kingdom, EN5 3DJ
        • Recruiting
        • Barnet Hospital
      • Cambridge, United Kingdom, CB2 0AY
        • Recruiting
        • Royal Papworth Hospital NHS Foundation Trust
      • Clydebank, United Kingdom, G81 4DY
        • Recruiting
        • Golden Jubilee National Hospital
      • Lincoln, United Kingdom, LN2 5QY
        • Recruiting
        • Lincoln County Hospital
      • Liverpool, United Kingdom, L9 7AL
        • Recruiting
        • Liverpool University Hospitals NHS Foundation Trust
      • Sheffield, United Kingdom, S5 7AU
        • Recruiting
        • Northern General Hospital
      • Stockton-On-Tees, United Kingdom, TS19 8PE
        • Recruiting
        • University Hospital of North Tees
    • Buckinghamshire
      • High Wycombe, Buckinghamshire, United Kingdom, HP11 2TT
        • Recruiting
        • Wycombe General Hospital
    • Dundee CITY
      • Dundee, Dundee CITY, United Kingdom, DD1 9SY
        • Recruiting
        • Ninewells Hospital and Medical School
    • England AND Wales
      • London, England AND Wales, United Kingdom, SW17 0QT
        • Recruiting
        • St. George's Hospital
    • London, CITY OF
      • Harrow, London, CITY OF, United Kingdom, HA1 3UJ
        • Recruiting
        • Northwick Park Hospital
    • Scotland
      • Glasgow, Scotland, United Kingdom, G31 2ER
        • Recruiting
        • Glasgow Royal Infirmary
  • United States
    • Alabama
      • Fairhope, Alabama, United States, 36532
        • Recruiting
        • Eastern shore Research Institute LLC
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck Medical Center of USC
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Medstar Washington Hospital Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Holy Cross Hospital
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Cardiology Associates of Fort Lauderdale
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Holy Cross Hospital/Jim Moran Heart & Vascular Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Emory University School of Medicine-Grady Campus
    • Illinois
      • Hazel Crest, Illinois, United States, 60429
        • Recruiting
        • Chicago Medical Research
    • Indiana
      • Richmond, Indiana, United States, 47374
        • Recruiting
        • Reid Physician Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
      • Traverse City, Michigan, United States, 49684
        • Active, not recruiting
        • Traverse Heart & Vascular
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • M Health Fairview Clinics and Surgery Center
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • M Health Fairview University of Minnesota Investigational Drug Services
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • M Health Fairview University of Minnesota Medical Center-East Bank
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota/Lillehei Clinical Research Unit
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke'S Hospital of Kansas City
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63108
        • Recruiting
        • Washington University in St. Louis Center for Outpatient Health (COH)
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University in St. Louis Center for Advanced Medicine (CAM)
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Recruiting
        • Holy Name Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina Medical Center
      • Chapel Hill, North Carolina, United States, 27599-7064
        • Recruiting
        • Clinical and Translational Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • Recruiting
        • South Oklahoma Heart Research, LLC
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Texas Health Physicians Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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. 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:

    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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Main cohort: ponsegromab low dose
Participants will receive a low dose Q4W SC
Drug: Main cohort: Ponsegromab low dose
Ponsegromab low dose subcutaneous injection
Other Names:
  • PF-06946860 low dose
Experimental: Main cohort: ponsegromab medium dose
Participants will receive a medium dose Q4W SC
Drug: Main cohort: Ponsegromab medium dose
Ponsegromab medium dose subcutaneous injection
Other Names:
  • PF-06946860 medium dose
Experimental: Main cohort: ponsegromab high dose
Participants will receive a high dose Q4W SC
Drug: Main cohort: ponsegromab high dose
Ponsegromab high dose subcutaneous injection
Other Names:
  • PF-06946860 high dose
Placebo Comparator: Main cohort: placebo
matched placebo
Other: Main cohort: Matched placebo
Matched placebo subcutaneous injection
Other Names:
  • Placebo
Experimental: Open-label, PK Cohort: ponsegromab low dose
Participants will receive a low dose Q4W SC
Drug: Open-label, PK Cohort: ponsegromab low dose
ponsegromab low dose subcutaneous injection
Other Names:
  • PF-06946860 low dose
Experimental: Open-label, PK Cohort: ponsegromab medium dose
Participants will receive a medium dose Q4W SC
Drug: Open-label, PK Cohort: ponsegromab medium dose
Ponsegromab medium dose subcutaneous injection
Other Names:
  • PF-06946860 medium dose
Experimental: Open-label, PK Cohort: ponsegromab high dose
Participants will receive a high dose Q4W SC
Drug: Open-label, PK Cohort: ponsegromab high dose
Ponsegromab high dose subcutaneous injection
Other Names:
  • PF-06946860 high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main cohort: Change from baseline in Kansas City Cardiomyopathy Questionnaire 23 Clinical Summary Score
Time Frame: baseline, 22 weeks
To compare the effect of ponsegromab versus placebo, on heart failure disease-specific health status in participants with heart failure
baseline, 22 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main cohort: Change from baseline in Kansas City Cardiomyopathy Questionnaire 23 Overall Summary Score
Time Frame: baseline, 22 weeks
To compare the effect of ponsegromab versus placebo on HF disease-specific overall health status in participants with HF
baseline, 22 weeks
Main cohort: Change from baseline in Kansas City Cardiomyopathy Questionnaire 23 Total Symptom Score
Time Frame: baseline, 22 weeks
To compare the effect of ponsegromab versus placebo on HF disease-specific overall health status in participants with HF
baseline, 22 weeks
Main cohort: Change from baseline in Kansas City Cardiomyopathy Questionnaire 23 physical limitations domain
Time Frame: baseline, 22 weeks
To compare the effect of ponsegromab versus placebo on HF disease-specific overall health status in participants with HF
baseline, 22 weeks
Main cohort: Responses as defined by a ≥5 point increase from baseline in Kansas City Cardiomyopathy Questionnaire 23 Clinical Summary Score
Time Frame: baseline, 22 weeks
To compare the effect of ponsegromab versus placebo on HF disease-specific health status in participants with HF
baseline, 22 weeks
Main cohort: Responses as defined by a ≥5 point increase from baseline in Overall Summary Score
Time Frame: baseline, 22 weeks
To compare the effect of ponsegromab versus placebo on HF disease-specific health status in participants with HF
baseline, 22 weeks
Main cohort: Responses as defined by a ≥5 point increase from baseline in Total Symptom Score
Time Frame: baseline, 22 weeks
To compare the effect of ponsegromab versus placebo on HF disease-specific health status in participants with HF
baseline, 22 weeks
Main cohort: Responses as defined by a ≥5 point increase from baseline in physical limitation
Time Frame: baseline, 22 weeks
To compare the effect of ponsegromab versus placebo on HF disease-specific health status in participants with HF
baseline, 22 weeks
Main cohort: Change from baseline in 6-Minute Walk Distance
Time Frame: baseline, 22 weeks
To compare the effect of ponsegromab versus placebo on the physical function of participants with HF
baseline, 22 weeks
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
Time Frame: baseline, 22 weeks
To compare the effect of ponsegromab versus placebo on fatigue reported by participants with HF
baseline, 22 weeks
Main cohort: Incidence of treatment-emergent adverse events
Time Frame: 32 weeks
To describe the safety and tolerability of ponsegromab in participants with HF
32 weeks
Main cohort: Incidence of treatment-emergent serious adverse events
Time Frame: 32 weeks
To describe the safety and tolerability of ponsegromab in participants with HF
32 weeks
Main cohort: Incidence of abnormal laboratory results
Time Frame: 32 weeks
To describe the safety and tolerability of ponsegromab in participants with HF
32 weeks
Main cohort: Incidence of abnormal vital signs
Time Frame: 32 weeks
To describe the safety and tolerability of ponsegromab in participants with HF
32 weeks
Open-Label, PK Cohort: Incidence of treatment-emergent adverse events
Time Frame: 22 weeks
To describe the safety and tolerability of ponsegromab in participants with HF
22 weeks
Open-Label, PK Cohort: Incidence of treatment-emergent serious adverse events
Time Frame: 22 weeks
To describe the safety and tolerability of ponsegromab in participants with HF
22 weeks
Open-Label, PK Cohort: Incidence of abnormal laboratory results
Time Frame: 22 weeks
To describe the safety and tolerability of ponsegromab in participants with HF
22 weeks
Open-Label, PK Cohort: Incidence of abnormal vital signs
Time Frame: 22 weeks
To describe the safety and tolerability of ponsegromab in participants with HF
22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Thrombolysis In Myocardial Infarction (TIMI)

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2022

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

June 7, 2025

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

August 5, 2022

First Posted (Actual)

August 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C3651011
  • 2022-001809-50 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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