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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05492500
Recruitment Status : Recruiting
First Posted : August 8, 2022
Last Update Posted : January 19, 2023
Sponsor:
Collaborator:
Thrombolysis In Myocardial Infarction (TIMI)
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Ponsegromab low dose Drug: Ponsegromab medium dose Drug: ponsegromab high dose Other: Matched placebo Phase 2

Detailed Description:
The primary purpose of this study is to assess the effect of repeated subcutaneous administration of ponsegromab (PF-06946860) 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In this study, ponsegromab will be administered at low, medium and high doses every 4 weeks by subcutaneous injections for a total of 6 doses. Participants will be randomized to 1 of the 3 doses of ponsegromab or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Investigators, sponsor, participants and other site staff will be blinded to participants' assigned study intervention, including the site staff assigned to prepare and administer the study intervention. Pharmacists and site personnel will be blinded to study intervention versus placebo within each study arm.
Primary Purpose: Supportive Care
Official Title: A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, 4-ARM STUDY TO INVESTIGATE SYMPTOMS, FUNCTION, HEALTH-RELATED QUALITY OF LIFE AND SAFETY WITH REPEATED SUBCUTANEOUS ADMINISTRATION OF PONSEGROMAB VERSUS PLACEBO IN ADULT PARTICIPANTS WITH HEART FAILURE
Actual Study Start Date : September 26, 2022
Estimated Primary Completion Date : September 9, 2024
Estimated Study Completion Date : November 18, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: ponsegromab low dose
Participants will receive a low dose Q4W SC
 Drug: Ponsegromab low dose
Ponsegromab low dose subcutaneous injection
Other Name: PF-06946860 low dose
Experimental: ponsegromab medium dose
Participants will receive a medium dose Q4W SC
 Drug: Ponsegromab medium dose
Ponsegromab medium dose subcutaneous injection
Other Name: PF-06946860 medium dose
Experimental: ponsegromab high dose
Participants will receive a high dose Q4W SC
 Drug: ponsegromab high dose
Ponsegromab high dose subcutaneous injection
Other Name: PF-06946860 high dose
Placebo Comparator: placebo
matched placebo
 Other: Matched placebo
Matched placebo subcutaneous injection
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Change from baseline in 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

  3. Change from baseline in physical limitation [ Time Frame: baseline, 22 weeks ]
    To compare the effect of ponsegromab versus placebo on HF disease-specific overall health status in participants with HF

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Change from baseline in heart failure Daily Diary fatigue score [ Time Frame: baseline, 22 weeks ]
    To compare the effect of ponsegromab versus placebo on fatigue reported by participants with HF

  10. 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

  11. Incidence of treatment-emergent adverse events [ Time Frame: 22 weeks ]
    To describe the safety and tolerability of ponsegromab in participants with HF

  12. Incidence of treatment-emergent serious adverse events [ Time Frame: 22 weeks ]
    To describe the safety and tolerability of ponsegromab in participants with HF

  13. Incidence of abnormal laboratory results [ Time Frame: 22 weeks ]
    To describe the safety and tolerability of ponsegromab in participants with HF

  14. Incidence of abnormal vital signs [ Time Frame: 22 weeks ]
    To describe the safety and tolerability of ponsegromab in participants with HF


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female participants aged 18 years or older

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

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

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

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

Exclusion Criteria:

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05492500


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Thrombolysis In Myocardial Infarction (TIMI)
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05492500    
Other Study ID Numbers: C3651011
2022-001809-50 ( EudraCT Number )
First Posted: August 8, 2022    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Heart Failure
N-terminal pro-B type natriuretic peptide
Kansas City Cardiomyopathy Questionnaire
Patient's Global Impression of Severity
 Patient's Global Impression of Change
Patient Reported Outcome Measurement Information System
Growth differentiation factor 15
New York Heart Association
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases