Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06200207
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-12-28
Brief Title:
A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATHENA
Brief 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 Participants 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-506988-34 | OTHER | European Medical Agency EMA | None |
| U1111-1293-7516 | OTHER | None | None |