NCT06200207

A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation

Effects of Ziltivekimab Versus Placebo on Heart Failure Symptoms and Physical Function in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 680 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.

Conditions

• Heart Failure
• Systemic Inflammation

Interventions

Type	Name	Description
DRUG	Ziltivekimab	Zilitivekimab will be administered subcutaneously once-monthly.
DRUG	Placebo	Placebo matched to ziltivekimab will be administered subcutaneously once-monthly.

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-10-01
• Completion: 2027-01-08
• First posted: 2024-01-10
• Last updated: 2026-04-07

Locations

240 sites across 16 countries: United States, Argentina, Australia, Bulgaria, Canada, Czechia, France, Germany, Greece, India, Malaysia, Poland, Portugal, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study