A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation
NCT06200207 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 680
Last updated 2026-04-07
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
- DRUG
-
Zilitivekimab will be administered subcutaneously once-monthly.
- DRUG
-
Placebo matched to ziltivekimab will be administered subcutaneously once-monthly.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Transparency dept. 2834 · Novo Nordisk A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-01
- Primary Completion
- 2026-10-01
- Completion
- 2027-01-08
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Bulgaria
- Canada
- Czechia
- France
- Germany
- Greece
- India
- Malaysia
- Poland
- Portugal
- Spain
- Turkey (Türkiye)
- United Kingdom
Study Locations
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