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ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation
Sponsor: Novo Nordisk A/S
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.
Official title: ZEUS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Participants With Established Atherosclerotic Cardiovascular Disease, Chronic Kidney Disease and Systemic Inflammation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
6385
Start Date
2021-08-30
Completion Date
2026-06-09
Last Updated
2026-09-28
Healthy Volunteers
No
Interventions
Ziltivekimab B
Administered subcutaneously (s.c., under skin) once-monthly added to standard of care.
Ziltivekimab C
Administered subcutaneously (s.c., under skin) once-monthly added to standard of care.
Placebo (Ziltivekimab B)
Administered subcutaneously (s.c., under skin) once-monthly added to standard of care.
Placebo (Ziltivekimab C)
Administered subcutaneously (s.c., under skin) once-monthly added to standard of care.
Locations (1073)
Uni of Alabama at Birmingham
Birmingham, Alabama, United States
Chambliss Clinical Trials LLC
Montgomery, Alabama, United States
Lenzmeier Fam Med CCT Research
Glendale, Arizona, United States
Aventiv Research Inc.
Mesa, Arizona, United States
Univ of Arkansas Med Sciences
Little Rock, Arkansas, United States
Unity Health-Searcy Medical Center
Searcy, Arkansas, United States
National Heart Institute Cal
Beverly Hills, California, United States
California Inst Of Renal Res
Chula Vista, California, United States
California Institute of Renal Research #10
Chula Vista, California, United States
Valley Clinical Trials
Covina, California, United States
Valiance Clinical Research
Huntington Park, California, United States
Scripps Wht Diab Inst La Jolla
La Jolla, California, United States
Balboa Nephro Med Gr Inc LaMes
La Mesa, California, United States
First Valley Medical Group
Lancaster, California, United States
VA Loma Linda Hlthcr Sys
Loma Linda, California, United States
Pacific Clinical Studies
Los Alamitos, California, United States
Angel City Research, Inc.
Los Angeles, California, United States
North America Research Institute
Lynwood, California, United States
Hoag Medical Group
Newport Beach, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, United States
Riverside Nephrology Physicians
Riverside, California, United States
N America Res Inst - San Dimas
San Dimas, California, United States
Lundquist Inst-Biomed Innovtn
Torrance, California, United States
Denver Health Outpatient Medical Center
Denver, Colorado, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
VA-Connecticut (VACHS)
West Haven, Connecticut, United States
George Washington Uni Med
Washington D.C., District of Columbia, United States
Excel Med Ctr Clinical Trials
Boca Raton, Florida, United States
Florida Premier Cardiology
Boynton Beach, Florida, United States
Innovative Research of W FL
Clearwater, Florida, United States
Northeast Research Institute
Fleming Island, Florida, United States
Integrative Research Assoc Inc
Fort Lauderdale, Florida, United States
Elixia Pines
Hollywood, Florida, United States
Encore Medical Research LLC
Hollywood, Florida, United States
Northeast Research Institute
Jacksonville, Florida, United States
Est Cst Inst for Rsrch,Jksnvil
Jacksonville, Florida, United States
Baptist Heart Specialists
Jacksonville, Florida, United States
Clinical Research of Cent FL
Lakeland, Florida, United States
Pharmax Research Clinic
Miami, Florida, United States
Life Spring Research Foundation LLC
Miami, Florida, United States
Allied Biomedical Research
Miami, Florida, United States
San Marcus Res Clin Miami Lakes
Miami Lakes, Florida, United States
Office of Kenneth Blaze DO
Miramar, Florida, United States
Suncoast Clin Res Port Richey
New Port Richey, Florida, United States
Suncoast Clinical Research, Inc.
Palm Harbor, Florida, United States
A&R Research Group, LLC
Pembroke Pines, Florida, United States
Hanson Clinical Research Center
Port Charlotte, Florida, United States
Peace River Cardiovascular Center
Port Charlotte, Florida, United States
Northeast Research Institute
Saint Augustine, Florida, United States
East Coast Institute for Research LLC_St. Augustine
Saint Augustine, Florida, United States
St Johns Center for Clin. Res
Saint Augustine, Florida, United States
Javara/Privia Med Grp GA,LLC
Albany, Georgia, United States
Southeastern Clinical R.I.
Augusta, Georgia, United States
Southeastern Clinical Research Institute, LLC
Augusta, Georgia, United States
Hope Clin Res & Wellness
Conyers, Georgia, United States
Javara Inc._Albany
Fayetteville, Georgia, United States
NSC Research, Inc
Johns Creek, Georgia, United States
Endo Res Solutions Inc
Roswell, Georgia, United States
Javara Inc._Winston Salem
Savannah, Georgia, United States
Saltzer Medical Group Research
Nampa, Idaho, United States
Endeavor Health Clinical Operations-NCH
Arlington Heights, Illinois, United States
Research by Design LLC
Chicago, Illinois, United States
Clinical Invest Special_Gurnee
Gurnee, Illinois, United States
Chicago Medical Research LLC
Hazel Crest, Illinois, United States
Endeavor Health
Skokie, Illinois, United States
Central Illinois Diabetes and Clinical Research
Springfield, Illinois, United States
Clin Invest Spec, Inc
Wauconda, Illinois, United States
MediSphere Medical RC
Evansville, Indiana, United States
Velocity Clin. Res Valparaiso
Valparaiso, Indiana, United States
Midwest Heart & Vasc Spec
Overland Park, Kansas, United States
Cotton O'Neil Diab & Endo Ctr
Topeka, Kansas, United States
Lexington VA Health Care System
Lexington, Kentucky, United States
The Research Group of Lexington LLC
Lexington, Kentucky, United States
Norton Heart Specialists-Springs
Louisville, Kentucky, United States
Grace Research, LLC
Bossier City, Louisiana, United States
Clinical Trials of Ame, LLC
Monroe, Louisiana, United States
IMA Clinical Research
Monroe, Louisiana, United States
Grace Research, LLC_Shreveport
Shreveport, Louisiana, United States
Louisiana Heart Center_Slidell
Slidell, Louisiana, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
Suburban Hospital
Bethesda, Maryland, United States
John P Hakim MD and Associates
Clinton, Maryland, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Mass General Community Physicians
Haverhill, Massachusetts, United States
Henry Ford Hospital_Detroit
Detroit, Michigan, United States
Elite Research Center
Flint, Michigan, United States
Healthy Heart Cardiology
Grand Rapids, Michigan, United States
McLaren Northern MI Hosp
Petoskey, Michigan, United States
AHS dba Abbot NW Hosp Diab Cen
Minneapolis, Minnesota, United States
University of Minnesota_Minneapolis_1
Minneapolis, Minnesota, United States
Clinical Research Consultants, LLC
Kansas City, Missouri, United States
Gateway CV Research Cntr Inc.
St Louis, Missouri, United States
St Louis Heart & Vascular, P.C.
St Louis, Missouri, United States
Nebraska Heart Institute_Lincoln
Lincoln, Nebraska, United States
VA NEB - Western IA Health Stm
Omaha, Nebraska, United States
Methodist Phys Clin Heart Cons
Omaha, Nebraska, United States
Univ of Nebraska Medical CTR
Omaha, Nebraska, United States
University of Nevada School of Medicine
Las Vegas, Nevada, United States
Palm Research Center Inc-Vegas
Las Vegas, Nevada, United States