Ponsegromab for Heart Failure
(GARDEN TIMI 74 Trial)
Recruiting in Palo Alto (17 mi)
+139 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Pfizer
Prior Safety Data
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.
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
PC
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
I experience significant weight loss, fatigue, or difficulty performing daily tasks.
I am 18 years old or older.
I have experienced significant weight loss, fatigue, or physical limitations recently.
See 9 more
Exclusion Criteria
I have cirrhosis with signs of increased blood pressure in the liver not caused by heart failure.
You have had a heart transplant, are waiting for a heart transplant, are using or planning to use a mechanical heart pump, or are using or planning to use strong heart medications given through a vein.
I have had a heart attack or other heart issue in the last month.
See 7 more
Treatment Details
Interventions
- Ponsegromab (Monoclonal Antibodies)
Trial OverviewThe study tests different doses of Ponsegromab against a placebo in people with heart failure to see if it improves their symptoms. Participants are randomly assigned to receive either the drug or placebo via injections every four weeks without knowing which one they get. There's also an open-label part where everyone gets Ponsegromab without any placebos involved.
Participant Groups
11Treatment groups
Experimental Treatment
Placebo Group
Group I: Optional Cohort D: ponsegromab high doseExperimental Treatment1 Intervention
Participants will receive a high dose Q4W SC
Group II: Optional Cohort C: ponsegromab low doseExperimental Treatment1 Intervention
Participants will receive a low dose Q4W SC
Group III: Open-label, PK Cohort (Cohort B): ponsegromab medium doseExperimental Treatment1 Intervention
Participants will receive a medium dose Q4W SC
Group IV: Open-label, PK Cohort (Cohort B): ponsegromab low doseExperimental Treatment1 Intervention
Participants will receive a low dose Q4W SC
Group V: Open-label, PK Cohort (Cohort B): ponsegromab high doseExperimental Treatment1 Intervention
Participants will receive a high dose Q4W SC
Group VI: Main cohort (Cohort A): ponsegromab medium doseExperimental Treatment1 Intervention
Participants will receive a medium dose Q4W SC
Group VII: Main cohort (Cohort A): ponsegromab low doseExperimental Treatment1 Intervention
Participants will receive a low dose Q4W SC
Group VIII: Main cohort (Cohort A): ponsegromab high doseExperimental Treatment1 Intervention
Participants will receive a high dose Q4W SC
Group IX: Main cohort (Cohort A): placeboPlacebo Group1 Intervention
matched placebo
Group X: Optional Cohort C: placeboPlacebo Group1 Intervention
matched placebo
Group XI: Optional Cohort D: placeboPlacebo Group1 Intervention
matched placebo
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
South Oklahoma Heart Research, LLCOklahoma City, OK
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de RimouskiRimouski, Canada
Centre Hospitalier de l'Université de MontréalMontréal, Canada
Institut de Cardiologie de MontrealMontreal, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Trials
4712
Patients Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13
The TIMI Study Group
Collaborator
Trials
22
Patients Recruited
129,000+
Thrombolysis In Myocardial Infarction (TIMI)
Collaborator
Trials
1
Patients Recruited
780+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Population Pharmacokinetics and Pharmacodynamics of Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction.Ruehs, H., Klein, D., Frei, M., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Reappraisal on pharmacological and mechanical treatments of heart failure.Liang, B., Zhao, YX., Zhang, XX., et al.[2020]
Vericiguat, a new drug that stimulates soluble guanylate cyclase, has been shown to reduce hospitalizations related to heart failure in patients already receiving guideline-directed medical therapy, indicating its efficacy in managing heart failure with reduced ejection fraction (HFrEF).
Despite advancements in treatment, patients with HFrEF still face a high risk of adverse outcomes, especially after worsening heart failure episodes, highlighting the need for additional therapeutic options like vericiguat to improve patient prognosis.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Vericiguat: The Fifth Harmony of Heart Failure with Reduced Ejection Fraction.Falco, L., Brescia, B., Catapano, D., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Emerging Pharmacologic Therapies for Heart Failure With Reduced Ejection Fraction.Chaudhary, AG., Alreefi, FM., Aziz, MA.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Efficacy and safety of vericiguat in heart failure: a meta-analysis.Ma, J., Guo, S., Jiang, H., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction.Armstrong, PW., Pieske, B., Anstrom, KJ., et al.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The efficacy and safety of soluble guanylate cyclase stimulators in patients with heart failure: A systematic review and meta-analysis.Zheng, X., Zheng, W., Xiong, B., et al.[2022]
Vericiguat, a newly approved oral medication for chronic heart failure, has shown efficacy in reducing all-cause mortality, cardiovascular deaths, and hospitalizations related to heart failure across various patient profiles, including those with high NT-proBNP levels.
While vericiguat demonstrates significant benefits in managing heart failure, concerns about its safety profile, particularly at higher dosages, suggest that careful monitoring is necessary during treatment.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Efficacy and Safety of Vericiguat for Treatment of Heart Failure: A Systematic Review.Shaikh, TG., Jawed, S., Rahmat, ZS., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Vericiguat in patients with heart failure and reduced ejection fraction.Špinar, J., Špinarová, L., Vítovec, J.[2022]
In the VICTORIA trial, vericiguat showed a significant reduction in heart failure hospitalizations or cardiovascular death, but the study found that both vericiguat and placebo led to similar improvements in left ventricular (LV) structure and function after 8 months, indicating that the benefits of vericiguat may not be solely due to reverse LV remodeling.
The study included 419 patients with heart failure with reduced ejection fraction (HFrEF) and demonstrated a trend towards a lower rate of the primary composite endpoint in the vericiguat group compared to placebo, suggesting potential clinical benefits that warrant further investigation.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Effect of vericiguat on left ventricular structure and function in patients with heart failure with reduced ejection fraction: The VICTORIA echocardiographic substudy.Pieske, B., Pieske-Kraigher, E., Lam, CSP., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Vericiguat: A Review in Chronic Heart Failure with Reduced Ejection Fraction.Kang, C., Lamb, YN.[2022]
Vericiguat was tested in a study involving patients with heart failure and reduced ejection fraction, showing significant efficacy in improving clinical outcomes compared to placebo.
The results suggest that vericiguat can be a beneficial treatment option for patients with this type of heart failure, potentially enhancing their quality of life and reducing hospitalizations.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Vericiguat reduced a composite of CV death or HF hospitalization in patients with HF and reduced LVEF.Averbuch, T., Van Spall, HGC.[2020]
References
Population Pharmacokinetics and Pharmacodynamics of Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. [2022]
Reappraisal on pharmacological and mechanical treatments of heart failure. [2020]
Vericiguat: The Fifth Harmony of Heart Failure with Reduced Ejection Fraction. [2023]
Emerging Pharmacologic Therapies for Heart Failure With Reduced Ejection Fraction. [2022]
Efficacy and safety of vericiguat in heart failure: a meta-analysis. [2023]
Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. [2021]
The efficacy and safety of soluble guanylate cyclase stimulators in patients with heart failure: A systematic review and meta-analysis. [2022]
Efficacy and Safety of Vericiguat for Treatment of Heart Failure: A Systematic Review. [2023]
Vericiguat in patients with heart failure and reduced ejection fraction. [2022]
Effect of vericiguat on left ventricular structure and function in patients with heart failure with reduced ejection fraction: The VICTORIA echocardiographic substudy. [2023]
Vericiguat: A Review in Chronic Heart Failure with Reduced Ejection Fraction. [2022]
Vericiguat reduced a composite of CV death or HF hospitalization in patients with HF and reduced LVEF. [2020]