457 Participants Needed

Ponsegromab for Heart Failure

(GARDEN TIMI 74 Trial)

Recruiting at 139 trial locations
PC
Overseen ByPfizer CT.gov Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Pfizer
Prior Safety DataThis treatment has passed at least one previous human 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?

The provided research does not contain any safety data for Ponsegromab (PF-06946860) in the treatment of heart failure. The studies focus on the safety and efficacy of Vericiguat, a different medication for heart failure.16789

Is the drug Ponsegromab a promising treatment for heart failure?

The provided research articles do not mention Ponsegromab or PF-06946860. Therefore, we cannot determine if Ponsegromab is a promising treatment for heart failure based on this information.58101112

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous administration of ponsegromab or placebo every four weeks

22 weeks
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants in the PK cohort receive open-label ponsegromab for further assessment

7 months
Monthly visits (in-person)

Treatment Details

Interventions

  • Ponsegromab
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

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

The TIMI Study Group

Collaborator

Trials
22
Recruited
129,000+

Thrombolysis In Myocardial Infarction (TIMI)

Collaborator

Trials
1
Recruited
780+

Findings from Research

Vericiguat, a new treatment for worsening chronic heart failure, has predictable pharmacokinetics and does not cause long-term changes in blood pressure, making it a safe option for patients with left ventricular ejection fraction < 45%.
The drug effectively reduces levels of NT-proBNP, a marker of heart failure severity, in an exposure-dependent manner, indicating its potential efficacy when combined with standard medical therapy.
Population Pharmacokinetics and Pharmacodynamics of Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction.Ruehs, H., Klein, D., Frei, M., et al.[2022]
Recent advances in heart failure (HF) treatment include new medications and devices that have been integrated into clinical practice, aiming to improve patient outcomes and reduce hospitalizations.
The review identifies common issues in current HF clinical studies and emphasizes the need for further research to address existing gaps, ultimately striving for better management of HF and decreased morbidity and mortality.
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.
Vericiguat: The Fifth Harmony of Heart Failure with Reduced Ejection Fraction.Falco, L., Brescia, B., Catapano, D., et al.[2023]

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]
9.Czech Republicpubmed.ncbi.nlm.nih.gov
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]
12.United Statespubmed.ncbi.nlm.nih.gov
Vericiguat reduced a composite of CV death or HF hospitalization in patients with HF and reduced LVEF. [2020]