Loading clinical trials...

A Study of Ponsegromab in People With Heart Failure | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study of Ponsegromab in People With Heart Failure

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 ADULT PARTICIPANTS WITH HEART FAILURE

NCT05492500•Pfizer

View on ClinicalTrials.gov

Summary

The primary purpose of this clinical trial is to compare the effects of study medicine (Ponsegromab/PF-06946860) with a placebo (an injection that looks like the study medicine but does not contain the active medicine) to find out if the study medicine is better than the placebo (an injection that looks like the study medicine but does not contain the active medicine) for treatment of symptoms related to heart failure. Participants will not know which treatment group they are assigned to. Most participants in this study will receive the study medicine or placebo by shots under the skin every four weeks. People may be able to participate in this study if they have heart failure. Participants will take part in this study for about 9 months. During this time participants will visit the study clinic once a month. A separate PK cohort within this clinical trial will receive open-label study medicine (Ponsegromab/PF-06946860) only. Participants in this open-label, PK cohort will not receive placebo. These participants will receive the study medicine by shots under the skin every four weeks. People may be able to participate in this study cohort if they also have heart failure. Participants will take part in the open-label, PK cohort for about 7 months.

Detailed Description

The primary purpose of this study is to assess the effect of repeated subcutaneous administration of ponsegromab (PF-06946860) compared to placebo on frequency, severity, and burden of symptoms as well as physical limitations in participants with heart failure and different ranges of circulating GDF-15 concentrations. The study will also assess the safety, tolerability, PK, PD, and immunogenicity of ponsegromab. A separate, open-label, PK cohort, with more frequent PK and GDF-15 collection after single and multiple subcutaneous administration of ponsegromab (PF-06946860), will be enrolled at certain sites to facilitate a more comprehensive assessment of PK characteristics and PK/PD relationship for GDF-15 in participants with heart failure and elevated circulating GDF-15 concentrations.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female participants aged 18 years or older
•-. Clinical evidence of HF with each of the following criteria:
•1. LVEF \<50% on most recent measurement, within 12 months of screening. Note: An assessment of LVEF in the prior 12 months is not required in situations where LVEF has been persistently \<50% on prior assessments obtained at least 3 months apart (including the most recent measurement).
•2. NYHA class II-IV at screening.
•3. NT-proBNP ≥400 pg/mL at screening (Note: Does not apply to open-label, PK Cohort \[Cohort B\]).
•Serum GDF-15 concentration ≥2000 pg/mL at screening.
•Cohort D only: Serum GDF-15 concentration \<2000 pg/mL at screening.
•KCCQ-23 CSS \<75 at screening (Note: Does not apply to open-label, PK Cohort \[Cohort B\]).
•Evidence of cachexia or fatigue or functional impairment, as demonstrated by at least one of the following at screening (Note: Does not apply to open-label, PK Cohort \[Cohort B\]):
•1. Non-edematous unintentional weight loss ≥5% in the last 6 months or current BMI \<20 kg/m2, associated with subjective fatigue or anorexia; or
+2 more criteria

Exclusion Criteria

•Acute decompensated HF within 1 month prior to Screening Visit 1 or during the screening period.
•Implantation of a cardiac resynchronization therapy device or valve repair or replacement within 3 months prior to randomization or intent to do so during the trial.
•For the open-label, PK cohort (Cohort B) only: implantation of a cardiac resynchronization therapy device more than 1 month prior to randomization is permitted.
•History of heart transplantation, currently listed for heart transplant, current/planned mechanical circulatory support, or current/planned use of intravenous inotropes (eg, dobutamine, milrinone).
•Acute coronary syndrome within 1 month prior to randomization.
•Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) within 3 months prior to randomization or intent to undergo coronary revascularization during the trial.
•For the open-label, PK cohort (Cohort B) only: coronary revascularization more than 1 month prior to randomization is permitted.
•Untreated indication for an implantable cardiac defibrillator or pacemaker to treat a cardiac rhythm abnormality (ie, tachyarrhythmia or bradyarrhythmia).
•Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives (whichever is longer) preceding the first dose of study intervention used in this study. Treatment with an investigational biologic agent within 6 months or 5 half-lives (whichever is longer) of Day 1.
•Previous exposure to ponsegromab in a prior clinical study.
+2 more criteria

Locations (122)

Eastern shore Research Institute LLC

Fairhope, Alabama, United States

Keck Medical Center of USC

Los Angeles, California, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Emory University School of Medicine-Grady Campus

Atlanta, Georgia, United States

Chicago Medical Research

Hazel Crest, Illinois, United States

Reid Physician Associates

Richmond, Indiana, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Traverse Heart & Vascular

Traverse City, Michigan, United States

M Health Fairview Clinics and Surgery Center

Minneapolis, Minnesota, United States

Key Dates

Start Date

September 26, 2022

Primary Completion Date

March 5, 2025

Completion Date

March 5, 2025

Last Updated

March 18, 2026

Enrollment

455

ACTUAL participants

Conditions

Heart Failure

Interventions

Main cohort (Cohort A): Ponsegromab low dose

DRUG

Main cohort (Cohort A): Ponsegromab medium dose

DRUG

Main cohort (Cohort A): ponsegromab high dose

DRUG

Main cohort (Cohort A): Matched placebo

OTHER

Open-label, PK Cohort (Cohort B): ponsegromab low dose

DRUG

Open-label, PK Cohort (Cohort B): ponsegromab medium dose

DRUG

Open-label, PK Cohort (Cohort B): ponsegromab high dose

DRUG

Optional Cohort C: Ponsegromab low dose

DRUG

Optional Cohort C: Matched placebo

OTHER

Optional Cohort D: Ponsegromab high dose

DRUG

Optional Cohort D: Matched placebo

OTHER

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

NCT07484009

Acute Heart Failure (AHF)Heart Failure (for Example, Fluid Overload)+1 more

View study

RECRUITING

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Ponsegromab in People With Heart Failure

Inclusion Criteria

Exclusion Criteria

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV

Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease

Assessment of Physical Activity and Cardiovascular Outcomes in Patients With Chronic Heart Failure