Condition
Cardiovascular Risk
Chronic Kidney Disease
Inflammation
Locations
Argentina, Australia, Belgium, Brazil, Canada, China, Croatia, Germany,
Greece, Hungary, India, Italy, Japan, Korea, Republic of, Lithuania,
Malaysia, Mexico, Netherlands, Poland, Romania, Serbia, Slovakia, South
Africa, Spain, Taiwan, Thailand, United Kingdom, United States
Start date
30/08/2021
Summary
This study is conducted to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation.
Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). This is known as the study medicine. Which 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 doctors cannot prescribe.
Participants will get the study medicine in a pre filled syringe. Participants will need to use the pre filled syringe to inject the study medicine into a skinfold once-monthly.
The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have blood and urine samples taken at most of the clinic visits.
Participants will have their heart examined using sound waves (echocardiography) and electrodes (electrocardiogram).
Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
Trial Overview:
Treatment
DRUG: Ziltivekimab B
DRUG: Ziltivekimab C
DRUG: Placebo (Ziltivekimab B)
DRUG: Placebo (Ziltivekimab C)
Study type
INTERVENTIONAL
Trial duration
Aug 30 2021 - Jan 29 2026
Estimated enrollment
6200
Phase
Not Available
Are you eligible?
Gender
Male and female
Age
18 years and older
Cardiovascular disease
Other
Find out how you can participate
Questions or concerns
Do you have any question about what it’s like being a clinical volunteer? Have a look at our answers to frequently asked questions.
This site contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice of a healthcare professional and should not be construed as providing advice or making a recommendation. The information on this site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specific product is correct for a particular patient. If you have questions regarding any information contained on this site you should consult a physician.