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

February 25, 2026 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

Terminated

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 different ranges of 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 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.

Study Type

Interventional

Enrollment (Actual)

455

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 Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4064
        • Core Research Group
      • Chermside, Queensland, Australia, 4032
        • The Prince Charles Hospital
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Lyell McEwin Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Fraser Clinical Trials Inc
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QEII Health Sciences Centre - Victoria General Site
    • Ontario
      • Cambridge, Ontario, Canada, N1R 7R1
        • Saul Vizel Professional Medicine Corporation dba Vizel Cardiac Research
      • London, Ontario, Canada, N6A 5A5
        • University Hospital - London Health Sciences Centre
      • North York, Ontario, Canada, M6B 3H7
        • North York Diagnostic and Cardiac Centre
      • Oshawa, Ontario, Canada, L1J 2K1
        • Private Practice - Dr. James Cha
      • Peterborough, Ontario, Canada, K9J 0B2
        • Kawartha Cardiology Clinical Trials
      • Toronto, Ontario, Canada, M5B 1W8
        • Unity Health Toronto, St. Michael's Hospital
      • Toronto, Ontario, Canada, M1B 5N1
        • Corcare
      • Winchester, Ontario, Canada, K0C 2K0
        • Winchester District Memorial Hospital
      • Winchester, Ontario, Canada, K0C 2K0
        • Community Care Building
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Institut de Cardiologie de Montreal
      • Montreal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l'Université de Montréal
      • Rimouski, Quebec, Canada, G5L 5T1
        • Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski
      • Saint-Jean-sur-Richelieu, Quebec, Canada, J3A 1J2
        • CardioVasc HR Inc
      • Terrebonne, Quebec, Canada, J6V 2H2
        • Centre intégré de santé et de services sociaux de Lanaudière - Hopital Pierre-Le Gardeur.
      • Trois-Rivières, Quebec, Canada, G9A 4P3
        • Diex Recherche Trois-Rivieres
  • China
      • Beijing, China, 100034
        • Peking University First Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital, Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People's Hospital
    • Hunan
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital of Central South University
      • Hengyang, Hunan, China, 421001
        • The First Affiliated Hospital of University of South China
    • Jilin
      • Changchun, Jilin, China, 130033
        • China-Japan Union Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Shandong
      • Jinan, Shandong, China, 250014
        • Qilu Hospital of Shandong University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Zhongshan Hospital,Fudan University
    • Shanxi
      • Yuncheng, Shanxi, China, 044000
        • Yuncheng Central Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300120
        • Tianjin People' s Hospital
  • Czechia
      • Prague, Czechia, 12808
        • Vseobecna Fakultni Nemocnice V Praze
      • Prague, Czechia, 100 34
        • Fakultní Nemocnice Královské Vinohrady
      • Prague, Czechia, 16902
        • Ustredni vojenska nemocnice
    • Náchod
      • Jaroměř, Náchod, Czechia, 551 01
        • EDUMED - Jaroměř
    • Praha 4
      • Prague, Praha 4, Czechia, 140 21
        • Institut Klinicke a Experimentalni Mediciny
    • South Moravian
      • Brno, South Moravian, Czechia, 602 00
        • Fakultni nemocnice u sv. Anny v Brne
  • Germany
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Universitätsklinikum Frankfurt Goethe-Universität
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • Universitätsmedizin Göttingen - Georg-August-Universität
    • North Rhine-Westphalia
      • Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
        • Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen
    • Saxony
      • Dresden, Saxony, Germany, 01277
        • Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Universitätsklinikum Jena
      • Jena, Thuringia, Germany, 7743
        • Universitätsklinikum Jena
  • Hungary
      • Budapest, Hungary, 1122
        • Semmelweis Egyetem
      • Budapest, Hungary, 1097
        • Dél-Pesti Centrumkórház Orszagos Hematologiai es Infektologiai Intezet
      • Nagykanizsa, Hungary, 8800
        • Kanizsai Dorottya Korhaz
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Pecsi Tudomanyegyetem Klinikai Kozpont
    • Bekes County
      • Békéscsaba, Bekes County, Hungary, 5600
        • Private Practice - Dr. Lakatos Ferenc
    • Győr-Moson-Sopron
      • Mosonmagyaróvár, Győr-Moson-Sopron, Hungary, 9200
        • TaNa Med
    • Nyíregyháza
      • Nyíregyháza, Nyíregyháza, Hungary, 4400
        • Medifarma 98 Kft
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Somogy Vármegyei Kaposi Mór Oktató Kórház
  • Japan
      • Osaka, Japan, 558-8558
        • Osaka General Medical Center
    • Hyōgo
      • Amagasaki, Hyōgo, Japan, 660-8550
        • Hyogo Prefectural Amagasaki General Medical Center
      • Himeji, Hyōgo, Japan, 670-8560
        • Hyogo Prefectural Harima-Himeji General Medical Center
      • Takarazuka, Hyōgo, Japan, 665-0873
        • Higashi Takarazuka Satoh Hospital
    • Iwate
      • Morioka, Iwate, Japan, 020-0066
        • Iwate Prefectural Central Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 983-8520
        • National Hospital Organization Sendai Medical Center
    • Osaka
      • Kishiwada, Osaka, Japan, 596-0042
        • Kishiwada Tokushukai Hospital
      • Suita, Osaka, Japan, 564-8565
        • National Cerebral and Cardiovascular Center
    • Saitama
      • Wako, Saitama, Japan, 351-0102
        • National Hospital Organization Saitama Hospital
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
  • Poland
      • Lodz, Poland, 92-213
        • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
      • Tychy, Poland, 43-100
        • Polsko Amerykanskie Kliniki Serca
      • Warsaw, Poland, 02-097
        • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital Kliniczny
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-848
        • Uniwersytecki Szpital Kliniczny w Poznaniu
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny w Białymstoku
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-555
        • Kardio Brynow
    • Warmian-Masurian Voivodeship
      • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-045
        • Miejski Szpital Zespolony w Olsztynie
  • Spain
      • Granada, Spain, 18012
        • Hospital Universitario Virgen Nieves
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Oviedo, Spain, 33011
        • Hospital Universitario Central de Asturias
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
    • A Coruña [LA Coruña]
      • A Coruña, A Coruña [LA Coruña], Spain, 15006
        • CHUAC-Complejo Hospitalario Universitario A Coruña
      • Santiago de Compostela, A Coruña [LA Coruña], Spain, 15706
        • CHUS - Hospital Clinico Universitario
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge
    • Barcelona [barcelona]
      • Barcelona, Barcelona [barcelona], Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Barcelona [barcelona], Spain, 08003
        • Parc de Salut Mar - Hospital del Mar
    • Catalunya [cataluña]
      • Barcelona, Catalunya [cataluña], Spain, 08041
        • Hospital De La Santa Creu I Sant Pau
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Majadahonda, Madrid, Comunidad de, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
    • Murcia, Región de
      • El Palmar, Murcia, Región de, Spain, 30120
        • Hospital Clínico Universitario Virgen de la Arrixaca
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Hospital Clinico de Valencia
  • United Kingdom
      • Barnet, United Kingdom, EN5 3DJ
        • Barnet Hospital
      • Cambridge, United Kingdom, CB2 0AY
        • Royal Papworth Hospital NHS Foundation Trust
      • Clydebank, United Kingdom, G81 4DY
        • Golden Jubilee National Hospital
      • Lincoln, United Kingdom, LN2 5QY
        • Lincoln County Hospital
      • Liverpool, United Kingdom, L9 7AL
        • Liverpool University Hospitals NHS Foundation Trust
      • Sheffield, United Kingdom, S5 7AU
        • Northern General Hospital
      • Stockton-on-Tees, United Kingdom, TS19 8PE
        • University Hospital of North Tees
    • Buckinghamshire
      • High Wycombe, Buckinghamshire, United Kingdom, HP11 2TT
        • Wycombe General Hospital
    • Dundee CITY
      • Dundee, Dundee CITY, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School
    • England and Wales
      • London, England and Wales, United Kingdom, SW17 0QT
        • St. George's Hospital
    • London, CITY of
      • Harrow, London, CITY of, United Kingdom, HA1 3UJ
        • Northwick Park Hospital
    • Scotland
      • Glasgow, Scotland, United Kingdom, G31 2ER
        • Glasgow Royal Infirmary
  • United States
    • Alabama
      • Fairhope, Alabama, United States, 36532
        • Eastern shore Research Institute LLC
    • California
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of USC
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Medstar Washington Hospital Center
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University School of Medicine-Grady Campus
    • Illinois
      • Hazel Crest, Illinois, United States, 60429
        • Chicago Medical Research
    • Indiana
      • Richmond, Indiana, United States, 47374
        • Reid Physician Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Traverse City, Michigan, United States, 49684
        • Traverse Heart & Vascular
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • M Health Fairview Clinics and Surgery Center
      • Minneapolis, Minnesota, United States, 55455
        • M Health Fairview University of Minnesota Investigational Drug Services
      • Minneapolis, Minnesota, United States, 55455
        • M Health Fairview University of Minnesota Medical Center-East Bank
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota/Lillehei Clinical Research Unit
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, United States, 63108
        • Washington University in St. Louis Center for Outpatient Health (COH)
      • St Louis, Missouri, United States, 63110
        • Washington University in St. Louis Center for Advanced Medicine (CAM)
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina Medical Center
      • Chapel Hill, North Carolina, United States, 27599
        • Clinical And Translational Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • South Oklahoma Heart Research, LLC
    • Texas
      • Dallas, Texas, United States, 75231
        • Texas Health Heart & Vascular Specialist (THHVS) #18760

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. 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:

  • 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 (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).

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 (Cohort A): ponsegromab low dose
Participants will receive a low dose Q4W SC
Drug: Main cohort (Cohort A): Ponsegromab low dose
Ponsegromab low dose subcutaneous injection
Other Names:
  • PF-06946860 low dose
Experimental: Main cohort (Cohort A): ponsegromab medium dose
Participants will receive a medium dose Q4W SC
Drug: Main cohort (Cohort A): Ponsegromab medium dose
Ponsegromab medium dose subcutaneous injection
Other Names:
  • PF-06946860 medium dose
Experimental: Main cohort (Cohort A): ponsegromab high dose
Participants will receive a high dose Q4W SC
Drug: Main cohort (Cohort A): ponsegromab high dose
Ponsegromab high dose subcutaneous injection
Other Names:
  • PF-06946860 high dose
Placebo Comparator: Main cohort (Cohort A): placebo
matched placebo
Other: Main cohort (Cohort A): Matched placebo
Matched placebo subcutaneous injection
Other Names:
  • Placebo
Experimental: Open-label, PK Cohort (Cohort B): ponsegromab low dose
Participants will receive a low dose Q4W SC
Drug: Open-label, PK Cohort (Cohort B): ponsegromab low dose
ponsegromab low dose subcutaneous injection
Other Names:
  • PF-06946860 low dose
Experimental: Open-label, PK Cohort (Cohort B): ponsegromab medium dose
Participants will receive a medium dose Q4W SC
Drug: Open-label, PK Cohort (Cohort B): ponsegromab medium dose
Ponsegromab medium dose subcutaneous injection
Other Names:
  • PF-06946860 medium dose
Experimental: Open-label, PK Cohort (Cohort B): ponsegromab high dose
Participants will receive a high dose Q4W SC
Drug: Open-label, PK Cohort (Cohort B): ponsegromab high dose
Ponsegromab high dose subcutaneous injection
Other Names:
  • PF-06946860 high dose
Experimental: Optional Cohort C: ponsegromab low dose
Participants will receive a low dose Q4W SC
Drug: Optional Cohort C: Ponsegromab low dose
Ponsegromab low dose subcutaneous injection
Other Names:
  • PF-06946860 low dose
Placebo Comparator: Optional Cohort C: placebo
matched placebo
Other: Optional Cohort C: Matched placebo
Matched placebo subcutaneous injection
Other Names:
  • Placebo
Experimental: Optional Cohort D: ponsegromab high dose
Participants will receive a high dose Q4W SC
Drug: Optional Cohort D: Ponsegromab high dose
Ponsegromab high dose subcutaneous injection
Other Names:
  • PF-06946860 high dose
Placebo Comparator: Optional Cohort D: placebo
matched placebo
Other: Optional Cohort D: Matched placebo
Matched placebo subcutaneous injection
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ)-23 - Clinical Summary Score (CSS) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
Time Frame: Baseline [the last measurement on study Day 1], Week 22
KCCQ is a self-reported 23-item questionnaire that assessed health related quality of life (HRQL) in participants with heart failure (HF) over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ total symptom score (TSS): mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status). KCCQ-23-CSS: mean of the TSS and physical limitation domain score; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-CSS signified better health status.
Baseline [the last measurement on study Day 1], Week 22

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in KCCQ-23 CSS at Week 22: Cohort A
Time Frame: Baseline [the last measurement on study Day 1], Week 22
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status). KCCQ-23-CSS: mean of the TSS and physical limitation domain score; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-CSS signified better health status.
Baseline [the last measurement on study Day 1], Week 22
Change From Baseline in KCCQ-23-Overall Summary Score (OSS) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
Time Frame: Baseline [the last measurement on study Day 1], Week 22
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-OSS: mean of domain scores- physical limitation, quality of life, social limitation and TSS (mean of symptom frequency and symptom burden); and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-OSS signified better health status.
Baseline [the last measurement on study Day 1], Week 22
Change From Baseline in KCCQ-23 OSS at Week 22: Cohort A
Time Frame: Baseline [the last measurement on study Day 1], Week 22
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-OSS: mean of domain scores- physical limitation, quality of life, social limitation and TSS (mean of symptom frequency and symptom burden); and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-OSS signified better health status.
Baseline [the last measurement on study Day 1], Week 22
Change From Baseline in KCCQ-23-TSS at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
Time Frame: Baseline [the last measurement on study Day 1], Week 22
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-TSS signified better health status.
Baseline [the last measurement on study Day 1], Week 22
Change From Baseline in KCCQ-23 TSS at Week 22: Cohort A
Time Frame: Baseline [the last measurement on study Day 1], Week 22
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-TSS signified better health status.
Baseline [the last measurement on study Day 1], Week 22
Change From Baseline in KCCQ-23 Physical Limitation Score at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
Time Frame: Baseline [the last measurement on study Day 1], Week 22
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23 physical limitation score scaled from 0 (worst status) to 100 (best possible status), where higher scores signified better health status.
Baseline [the last measurement on study Day 1], Week 22
Change From Baseline in KCCQ-23 Physical Limitation Score at Week 22: Cohort A
Time Frame: Baseline [the last measurement on study Day 1], Week 22
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23 physical limitation score scaled from 0 (worst status) to 100 (best possible status), where higher scores signified better health status.
Baseline [the last measurement on study Day 1], Week 22
Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23-CSS at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
Time Frame: Week 22
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status). KCCQ-23-CSS: mean of the TSS and physical limitation domain score; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-CSS signified better health status.
Week 22
Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 CSS Score at Week 22: Cohort A
Time Frame: Week 22
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status). KCCQ-23-CSS: mean of the TSS and physical limitation domain score; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-CSS signified better health status.
Week 22
Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 OSS Score at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
Time Frame: Week 22
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-OSS: mean of domain scores- physical limitation, quality of life, social limitation and TSS (mean of symptom frequency and symptom burden); and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-OSS signified better health status.
Week 22
Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 OSS Score at Week 22: Cohort A
Time Frame: Week 22
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-OSS: mean of domain scores- physical limitation, quality of life, social limitation and TSS (mean of symptom frequency and symptom burden); and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-OSS signified better health status.
Week 22
Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 TSS Score at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
Time Frame: Week 22
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-TSS signified better health status.
Week 22
Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 TSS Score at Week 22: Cohort A
Time Frame: Week 22
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23-TSS: mean of domains- symptom frequency and symptom burden; and was transformed to a single score which ranged from 0 (worst) to 100 (best possible status), where higher KCCQ-23-TSS signified better health status.
Week 22
Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 PL Score at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
Time Frame: Week 22
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23 physical limitation score scaled from 0 (worst status) to 100 (best possible status), where higher scores signified better health status.
Week 22
Percentage of Participants With >= 5-Point Increase From Baseline in KCCQ-23 PL Score at Week 22: Cohort A
Time Frame: Week 22
KCCQ is a self-reported 23-item questionnaire that assessed HRQL in participants with HF over the past 2 weeks. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 (worst status) to 100 (best possible status). KCCQ-23 physical limitation score scaled from 0 (worst status) to 100 (best possible status), where higher scores signified better health status.
Week 22
Change From Baseline in 6-Minute Walk Distance (6MWD) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
Time Frame: Baseline [the last measurement on study Day 1], Week 22
The 6-minute walk test (6MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6MWD (distance travelled in meters) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Baseline [the last measurement on study Day 1], Week 22
Change From Baseline in 6MWD at Week 22: Cohort A
Time Frame: Baseline [the last measurement on study Day 1], Week 22
The 6MWT is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6MWD (distance travelled in meters) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Baseline [the last measurement on study Day 1], Week 22
Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue (Version 7a) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
Time Frame: Baseline [the last measurement on study Day 1], Week 22
The PROMIS Fatigue 7a is a self-reported measure that assessed a range of symptoms in the past 7 days from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. The short form (SF) 7A consisted of 7 items that study participants rated from 1: "Never" to 5: "Always". A global raw score ranged from 7 to 35 was calculated and translated into a T-score with minimum of 29.4 and maximum of 83.2 (mean = 50, a standard deviation [SD] = 10) using the applicable score conversion provided in the PROMIS user's manual. Higher scores indicated more fatigue.
Baseline [the last measurement on study Day 1], Week 22
Change From Baseline in PROMIS Fatigue (Version 7a) at Week 22: Cohort A
Time Frame: Baseline [the last measurement on study Day 1], Week 22
The PROMIS Fatigue 7a is a self-reported measure that assessed a range of symptoms in the past 7 days from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. The short form (SF) 7A consisted of 7 items that study participants rated from 1: "Never" to 5: "Always". A global raw score ranged from 7 to 35 was calculated and translated into a T-score (mean = 50, a standard deviation [SD] = 10) using the applicable score conversion provided in the PROMIS user's manual. Higher scores indicated more fatigue.
Baseline [the last measurement on study Day 1], Week 22
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs): Cohort A
Time Frame: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks)
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. TESAE was a TEAE which met the definition of serious adverse event (SAE) viz. any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was considered an important medical event. AEs included SAEs and all other AEs (non-SAEs).
From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks)
Number of Participants With Any Abnormalities in Laboratory Test Parameters: Cohort A
Time Frame: From first dose of study treatment (Day 1) up to Week 22
Laboratory parameters included were: hematology (hemoglobin, hematocrit, red blood cells [RBC] count, platelet count, white blood cells [WBC] count) and chemistry (urea and creatinine, estimated glomerular filtration rate [eGFR], cystatin C [at baseline only], sodium, potassium, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase [ALP], total protein, glucose [non-fasting] and lipid panel, total cholesterol, high-density lipoprotein [HDL] cholesterol, Non HDL cholesterol, calculated low-density lipoprotein [LDL] cholesterol and triglycerides. Number of participants with any abnormalities in laboratory test parameters as judged by investigator were reported.
From first dose of study treatment (Day 1) up to Week 22
Number of Participants With Abnormalities in Vital Signs: Cohort A
Time Frame: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks)
Vital signs abnormalities criteria included: supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg), increase and decrease in change of >= 30mmHg; supine diastolic blood pressure (DBP) <50 mmHg, increase and decrease in change of >=20mmHg; and pulse rate (PR) <40 beats per minute (bpm) and >120 bpm.
From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 22 (maximum up to approximately 32 weeks)
Number of Participants With TEAEs and TEASAEs: Cohort B
Time Frame: From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. TESAE was a TEAE which met the definition of SAE viz. any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was considered an important medical event. AEs included SAEs and all other AEs (non-SAEs).
From first dose of study treatment (Day 1) maximum up to 10 weeks post Week 12 (maximum up to approximately 22 weeks)
Number of Participants With Any Abnormalities in Laboratory Test Parameters: Cohort B
Time Frame: From first dose of study treatment (Day 1) maximum up to 4 weeks post Week 12 (maximum up to approximately 16 weeks)
Laboratory parameters included were: hematology (hemoglobin, hematocrit, RBC count, platelet count, WBC count) and chemistry (urea and creatinine, eGFR, cystatin C [at baseline only], sodium, potassium, AST, ALT, total bilirubin, ALP, total protein, glucose [non-fasting] and lipid panel, total cholesterol, HDL cholesterol, Non HDL cholesterol, calculated LDL cholesterol and triglycerides. Number of participants with any abnormalities in laboratory test parameters as judged by investigator were reported.
From first dose of study treatment (Day 1) maximum up to 4 weeks post Week 12 (maximum up to approximately 16 weeks)
Number of Participants With Abnormalities in Vital Signs: Cohort B
Time Frame: From start of study drug on Day 1 maximum up to 4weeks post last dose on Week 12 (maximum up to approximately Week 16)
Vital signs criteria included: supine SBP <90 mmHg, increase and decrease in change of >= 30mmHg; supine DBP <50 mmHg, increase and decrease in change of >=20mmHg; and PR <40 bpm to >120 bpm.
From start of study drug on Day 1 maximum up to 4weeks post last dose on Week 12 (maximum up to approximately Week 16)

Collaborators and Investigators

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

Sponsor

Pfizer

Collaborators

The TIMI Study Group

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 (Actual)

March 5, 2025

Study Completion (Actual)

March 5, 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)

March 18, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C3651011
  • 2023-509747-27-00 (Registry Identifier: CTIS (EU))

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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