A Study of Ponsegromab in People With Heart Failure

Conditions

• Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Sep 26, 2022

Status verified

Feb 2026

Primary completion

Mar 5, 2025

Completion

Mar 5, 2025

Study Design

Enrollment

455 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Main cohort (Cohort A): ponsegromab low dose
  Participants will receive a low dose Q4W SC
• Experimental: Main cohort (Cohort A): ponsegromab medium dose
  Participants will receive a medium dose Q4W SC
• Experimental: Main cohort (Cohort A): ponsegromab high dose
  Participants will receive a high dose Q4W SC
• Placebo Comparator: Main cohort (Cohort A): placebo
  matched placebo
• Experimental: Open-label, PK Cohort (Cohort B): ponsegromab low dose
  Participants will receive a low dose Q4W SC
• Experimental: Open-label, PK Cohort (Cohort B): ponsegromab medium dose
  Participants will receive a medium dose Q4W SC
• Experimental: Open-label, PK Cohort (Cohort B): ponsegromab high dose
  Participants will receive a high dose Q4W SC
• Experimental: Optional Cohort C: ponsegromab low dose
  Participants will receive a low dose Q4W SC
• Placebo Comparator: Optional Cohort C: placebo
  matched placebo
• Experimental: Optional Cohort D: ponsegromab high dose
  Participants will receive a high dose Q4W SC
• Placebo Comparator: Optional Cohort D: placebo
  matched placebo

Primary Outcome Measure

Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ)-23 - Clinical Summary Score (CSS) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo [ Time Frame: Baseline [the last measurement on study Day 1], Week 22 ]

Locations (22)

Related coverage on Hipa.ai

• Ponsegromab Phase 2 Trial for Heart Failure Shows No Significant Improvement…
  ponsegromab · Mar 18, 2026 · ClinicalTrials.gov

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