Ponsegromab for Heart Failure
(GARDEN TIMI 74 Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing Ponsegromab, a new medicine, to see if it can help people with heart failure who have high levels of GDF-15. The medicine is given as an injection under the skin and aims to reduce heart failure symptoms by targeting the GDF-15 protein.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it does exclude participants who have used investigational products recently. It's best to discuss your specific medications with the trial team.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the idea that Ponsegromab for Heart Failure is an effective treatment?
The available research does not provide specific data on Ponsegromab for Heart Failure. Instead, it focuses on another drug called Vericiguat, which has shown effectiveness in reducing hospitalizations related to heart failure. Without specific data on Ponsegromab, we cannot compare its effectiveness to Vericiguat or other treatments for heart failure.12345
What safety data is available for Ponsegromab (PF-06946860) in heart failure treatment?
Research Team
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
This trial is for adults with heart failure who experience symptoms like unintentional weight loss, fatigue, or physical limitations. They must have a left ventricular ejection fraction (LVEF) of less than 50% and elevated levels of certain heart-related biomarkers. People with recent major cardiac procedures, acute coronary syndrome, untreated rhythm disorders, severe liver disease not caused by heart failure, or those on dialysis cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous administration of ponsegromab or placebo every four weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants in the PK cohort receive open-label ponsegromab for further assessment
Treatment Details
Interventions
- Ponsegromab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
The TIMI Study Group
Collaborator
Thrombolysis In Myocardial Infarction (TIMI)
Collaborator