A Study of Ponsegromab in People With Heart Failure

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.

Conditions

• Heart Failure

Interventions

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

Sponsors & Collaborators

• The TIMI Study Group

  collaborator OTHER

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-26

Primary Completion

2025-03-05

Completion

2025-03-05

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• China
• Czechia
• Germany
• Hungary
• Japan
• Poland
• Spain
• United Kingdom

Study Locations