A research study to look at how ziltivekimab works compared to placebo in people with heart failure and inflammation (HERMES)
A research study to look at how ziltivekimab works compared to placebo in people with heart failure and inflammation (HERMES)
ClinicalTrials.gov ID: NCT05636176
Sponsor: Novo Nordisk A/S
Information provided by: Novo Nordisk A/S (Responsible Party)
Last Update Posted: 2024-10-15
Brief Summary:
This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.
Official Title:
Effects of Ziltivekimab Versus Placebo on Morbidity and Mortality in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation
Intervention / Treatment:
- Drug: Ziltivekimab
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) |
2023-05-08
|
| Primary Completion (Estimated) |
2027-07-02
|
| Study Completion (Estimated) |
2027-07-02
|
| Enrollment (Estimated) | 5600 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers | EX6018-4915 U1111-1280-0810 ( Other Identifier ) (OTHER: World Health Organization (WHO)) 2022-501939-16-00 ( Other Identifier ) (OTHER: European Medicines Agency (EMA)) jRCT2031230085 ( Registry Identifier ) (REGISTRY: jRCT (Japan)) |