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

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

ClinicalTrials.gov ID: NCT05492500
Sponsor: Pfizer
Information provided by: Pfizer (Responsible Party)
Last Update Posted: 2024-10-26

Brief Summary:
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.

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.

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.

Intervention / Treatment: 
- Drug: Main cohort (Cohort A): Ponsegromab low dose
- Drug: Main cohort (Cohort A): Ponsegromab medium dose
- Drug: Main cohort (Cohort A): ponsegromab high dose
- Other: Main cohort (Cohort A): Matched placebo
- Drug: Open-label, PK Cohort (Cohort B): ponsegromab low dose
- Drug: Open-label, PK Cohort (Cohort B): ponsegromab medium dose
- Drug: Open-label, PK Cohort (Cohort B): ponsegromab high dose
- Drug: Optional Cohort C: Ponsegromab low dose
- Other: Optional Cohort C: Matched placebo
- Drug: Optional Cohort D: Ponsegromab high dose
- Other: Optional Cohort D: Matched placebo

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