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

Conditions

• Heart Failure
• Systemic Inflammation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ziltivekimab — DRUG
  Zilitivekimab will be administered subcutaneously once-monthly.
• Placebo — DRUG
  Placebo matched to ziltivekimab will be administered subcutaneously once-monthly.

Study Details

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.

Key Dates

Start date

Apr 1, 2024

Status verified

Apr 2026

Primary completion

Oct 1, 2026

Completion

Jan 8, 2027

Study Design

Enrollment

680 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Ziltivekimab
  Participants will receive ziltivekimab administered subcutaneously (s.c.) once-monthly and added to standard of care for 12 months.
• Placebo Comparator: Placebo
  Participants will receive placebo matched to ziltivekimab administered s.c. once-monthly and added to standard of care for 12 months.

Primary Outcome Measure

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS) [ Time Frame: From randomisation (month 0) to end-of-treatment (month 12) ]

Central Contacts

• Novo Nordisk
  (+1) 866-867-7178
  [email protected]

Locations (41)

Find similar trials in Alexander City, AL

Related Studies

• Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
  Recruiting · Medtronic · Birmingham, Alabama
• Identification of Genomic Predictors of Adverse Events After Cardiac Surgery
  Recruiting · Brigham and Women's Hospital · Boston, Massachusetts
• Cardiovascular Health Improvement Project
  Recruiting · University of Michigan · Ann Arbor, Michigan
• Utility of Thenar Near Infrared Spectroscopy (NIRS) in Pediatric Patients With Heart Failure
  Recruiting · University of Florida · Gainesville, Florida