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Monoclonal Antibodies

Ponsegromab for Heart Failure (GARDEN TIMI 74 Trial)

Phase 2
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Evidence of cachexia or fatigue or functional impairment, as demonstrated by at least one of the following: Non-edematous unintentional weight loss ≥5% in the last 6 months or current BMI <20 kg/m2, associated with subjective fatigue or anorexia; or Fatigue at least 3 times per week AND at least moderately bothersome fatigue in the past 2 weeks; or A score of <60 on the Physical Limitations Domain of the KCCQ 23 administered at screening.
Fatigue at least 3 times per week AND at least moderately bothersome fatigue in the past 2 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 weeks
Awards & highlights

GARDEN TIMI 74 Trial Summary

This trial is testing whether a new drug is better than a placebo at treating heart failure symptoms. Participants will be given either the drug or the placebo by injection every four weeks, and won't know which they're getting. The trial will last for nine months.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
While specific side effects for Ponsegromab aren't listed here, common side effects from medications like this can include reactions at the injection site, nausea, headaches, and potential allergic responses. The exact side effects will be monitored throughout the trial.

GARDEN TIMI 74 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have experienced significant weight loss, fatigue, or physical limitations recently.
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I experience fatigue at least 3 times a week and it significantly bothers me.
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I have moderate to severe heart condition symptoms.
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I've lost more than 5% of my weight without trying in the last 6 months or my BMI is below 20, and I feel tired or have little appetite.
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I am experiencing significant weight loss, fatigue, or difficulty performing daily tasks.
Select...
I have been diagnosed with heart failure.

GARDEN TIMI 74 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~32 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 32 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Main cohort: Change from baseline in Kansas City Cardiomyopathy Questionnaire 23 Clinical Summary Score
Secondary outcome measures
Main cohort: Change from baseline in 6-Minute Walk Distance
Main cohort: Change from baseline in Kansas City Cardiomyopathy Questionnaire 23 Overall Summary Score
Main cohort: Change from baseline in Kansas City Cardiomyopathy Questionnaire 23 Total Symptom Score
+14 more

GARDEN TIMI 74 Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: Open-label, PK Cohort: ponsegromab medium doseExperimental Treatment1 Intervention
Participants will receive a medium dose Q4W SC
Group II: Open-label, PK Cohort: ponsegromab low doseExperimental Treatment1 Intervention
Participants will receive a low dose Q4W SC
Group III: Open-label, PK Cohort: ponsegromab high doseExperimental Treatment1 Intervention
Participants will receive a high dose Q4W SC
Group IV: Main cohort: ponsegromab medium doseExperimental Treatment1 Intervention
Participants will receive a medium dose Q4W SC
Group V: Main cohort: ponsegromab low doseExperimental Treatment1 Intervention
Participants will receive a low dose Q4W SC
Group VI: Main cohort: ponsegromab high doseExperimental Treatment1 Intervention
Participants will receive a high dose Q4W SC
Group VII: Main cohort: placeboPlacebo Group1 Intervention
matched placebo

Find a Location

Who is running the clinical trial?

Thrombolysis In Myocardial Infarction (TIMI)UNKNOWN
PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,610 Total Patients Enrolled
20 Trials studying Heart Failure
6,809 Patients Enrolled for Heart Failure
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,091,805 Total Patients Enrolled
9 Trials studying Heart Failure
5,836 Patients Enrolled for Heart Failure

Media Library

Ponsegromab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05492500 — Phase 2
Heart Failure Research Study Groups: Open-label, PK Cohort: ponsegromab medium dose, Open-label, PK Cohort: ponsegromab low dose, Main cohort: placebo, Main cohort: ponsegromab low dose, Main cohort: ponsegromab medium dose, Main cohort: ponsegromab high dose, Open-label, PK Cohort: ponsegromab high dose
Heart Failure Clinical Trial 2023: Ponsegromab Highlights & Side Effects. Trial Name: NCT05492500 — Phase 2
Ponsegromab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05492500 — Phase 2
Heart Failure Patient Testimony for trial: Trial Name: NCT05492500 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you tell me how many medical facilities are testing this treatment in our state?

"The research is being conducted out of South Oklahoma Heart Research, LLC in Oklahoma City, Oklahoma, Reid Physician Associates in Richmond, Indiana, and Oklahoma Heart Hospital in Hazel Crest, Illinois as well as other sites."

Answered by AI

Has ponsegromab been approved by the FDA for use at lower doses?

"Ponsegromab low dose is still being studied for safety and efficacy in Phase 2 clinical trials, so it received a score of 2."

Answered by AI

Is it possible to join this clinical trial at present?

"Yes, according to the information on clinicaltrials.gov, this particular trial is still recruiting patients. The study was posted on 9/26/2022 and updated as recently as 10/27/2022. They are hoping to enroll 416 patients from 5 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What site did they apply to?
Traverse Heart & Vascular
Emory University School of Medicine-Grady Campus
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I've been on meds for 3 years now and had a mitral valve clip that's made me worse. I'm only 53 and would like to improve my quality of life.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study of Ponsegromab in People With Heart Failure
2022. "A Study of Ponsegromab in People With Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05492500.
~153 spots leftby Mar 2025
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