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.
Timeline
- Start
- 2022-09-26
- Primary completion
- 2025-03-05
- Completion
- 2025-03-05
Outcome
Missed primary endpoint
Stopped: “Following a prespecified interim analysis, and in consultation with the independent Data Monitoring Committee, the Sponsor terminated the study”
registry p = 0.4360; Least square (LS) mean difference 0.31 (90% CI -2.91 to 3.54) NCT05492500 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ponsegromab | Monoclonal antibody | — | Subcutaneous |