A Study of Ponsegromab in People With Heart Failure
← catalyst calendarSponsored by Pfizer (industry) · PFE — their whole pipeline →. With The TIMI Study Group.
Phase
Phase 2
Status
Terminated
Study type
Interventional
Design
Randomized · Quadruple · Supportive care
Enrollment
455actual
Sites
122
Countries
Australia, Canada, China +8
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Following a prespecified interim analysis, and in consultation with the independent Data Monitoring Committee, the Sponsor terminated the study
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-09-26 | actual | When the study began enrolling |
| Primary completion | 2025-03-05 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-03-05 | actual | The whole study's end, after follow-up |
| First posted | 2022-08-08 | actual | When this record first appeared on the registry |
| Results posted | 2026-03-18 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-03-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Heart Failure
Interventions
- Drug: Main cohort (Cohort A): Ponsegromab low dose — also filed as PF-06946860 low dose
- Drug: Main cohort (Cohort A): Ponsegromab medium dose — also filed as PF-06946860 medium dose
- Drug: Main cohort (Cohort A): ponsegromab high dose — also filed as PF-06946860 high dose
- Other: Main cohort (Cohort A): Matched placebo — also filed as Placebo
- Drug: Open-label, PK Cohort (Cohort B): ponsegromab low dose — also filed as PF-06946860 low dose
- Drug: Open-label, PK Cohort (Cohort B): ponsegromab medium dose — also filed as PF-06946860 medium dose
- Drug: Open-label, PK Cohort (Cohort B): ponsegromab high dose — also filed as PF-06946860 high dose
- Drug: Optional Cohort C: Ponsegromab low dose — also filed as PF-06946860 low dose
- Other: Optional Cohort C: Matched placebo — also filed as Placebo
- Drug: Optional Cohort D: Ponsegromab high dose — also filed as PF-06946860 high dose
- Other: Optional Cohort D: Matched placebo — also filed as Placebo
Primary outcome
what the primary-completion date above is the date OFChange From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ)-23 - Clinical Summary Score (CSS) at Week 22: Cohort A, Ponsegromab 300 mg Versus Placebo
measured Baseline [the last measurement on study Day 1], Week 22
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-07-20 · 1.4 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-10-21 · 9.5 MB · SAP_001.pdf
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