GARDEN-TIMI 74
Research type
Research Study
Full 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 ADULTPARTICIPANTS WITH HEART FAILURE
IRAS ID
1006125
Contact name
Michelle Rossulek
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2022-001809-50
Clinicaltrials.gov Identifier
Research summary
Heart failure is a chronic condition in which the impaired heart muscle does not pump blood as well as it should which can cause shortness of breath, swelling of the legs and feet, and reduce a person’s ability to perform activities of daily life. Heart failure can be stabilized with medications and/or therapeutic devices or treated in acceptable candidates with heart transplantation. The primary goals of heart failure care are the prevention of disease progression, improvement of symptoms, and the prevention of cardiovascular death.
Growth Differentiating Factor-15 (GDF-15) a well-established marker of cardiovascular disease and death. Elevated GDF-15 blood levels may be responsible for some underlying symptoms of heart failure, including fatigue, loss of appetite, weight loss, and impaired mobility. Ponsegromab (PF-06946860) is a monoclonal antibody that targets and blocks circulating GDF-15.
The purpose of this study is to compare the effects of ponsegromab with a placebo (a solution that looks like the study medicine but does not contain the active medicine) in participants with heart failure to find out if ponsegromab is better than the placebo for treatment of symptoms related to heart failure, improving quality of life and reducing GDF-15 blood levels. All participants in this study will visit the study clinic about every four weeks and receive ponsegromab or placebo by shots under the skin. Participants will also undergo assessment of their ability to perform everyday activities and quality of life as well as biological sampling to determine how they are responding to ponsegromab and/or heart failure progression. Participants will not know which treatment group they are assigned to. This study will also assess the safety and tolerability of ponsegromab in participants with heart failure. Participants will take part in this study for about 9 months at study sites that specialize in treatment of heart failure.REC name
East of England - Essex Research Ethics Committee
REC reference
22/EE/0262
Date of REC Opinion
17 Feb 2023
REC opinion
Further Information Favourable Opinion