NCT05492500

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 455 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Main cohort (Cohort A): Ponsegromab low dose	Ponsegromab low dose subcutaneous injection
DRUG	Main cohort (Cohort A): Ponsegromab medium dose	Ponsegromab medium dose subcutaneous injection
DRUG	Main cohort (Cohort A): ponsegromab high dose	Ponsegromab high dose subcutaneous injection
OTHER	Main cohort (Cohort A): Matched placebo	Matched placebo subcutaneous injection
DRUG	Open-label, PK Cohort (Cohort B): ponsegromab low dose	ponsegromab low dose subcutaneous injection
DRUG	Open-label, PK Cohort (Cohort B): ponsegromab medium dose	Ponsegromab medium dose subcutaneous injection
DRUG	Open-label, PK Cohort (Cohort B): ponsegromab high dose	Ponsegromab high dose subcutaneous injection
DRUG	Optional Cohort C: Ponsegromab low dose	Ponsegromab low dose subcutaneous injection
OTHER	Optional Cohort C: Matched placebo	Matched placebo subcutaneous injection
DRUG	Optional Cohort D: Ponsegromab high dose	Ponsegromab high dose subcutaneous injection
OTHER	Optional Cohort D: Matched placebo	Matched placebo subcutaneous injection

Timeline

• Start date: 2022-09-26
• Primary completion: 2025-03-05
• Completion: 2025-03-05
• First posted: 2022-08-08
• Last updated: 2026-03-18
• Results posted: 2026-03-18

Locations

122 sites across 11 countries: United States, Australia, Canada, China, Czechia, Germany, Hungary, Japan, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study