Print

Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Chronic kidney disease defined by one of the below: 1. Estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 15 and below 60 mL/min/1.73 m^2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation) 2. Urinary albumin-to-creatinine ratio (UACR) >= 200 milligrams per gram (mg/g) and eGFR >= 60 mL/min/1.73 m2 (using the CKD-EPI creatinine equation) - Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 milligram per liter (mg/L) - Evidence of atherosclerotic cardiovascular disease (ASCVD) by one or more of the following: a) Coronary heart disease defined as at least one of the following: i. Documented history of MI ii. Prior coronary revascularisation procedure iii. greater than or equal to 50% stenosis in major epicardial coronary artery documented by cardiac catheterisation or CT coronary angiography b) Cerebrovascular disease defined as at least one of the following: i. Prior stroke of atherosclerotic origin ii. Prior carotid artery revascularisation procedure iii. greater than or equal to 50% stenosis in carotid artery documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound. c) Symptomatic peripheral artery disease (PAD) defined as at least one of the following: i. Intermittent claudication with an ankle-brachial index (ABI) below or equal to 0.90 at rest ii. Intermittent claudication with a greater than or equal to 50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound iii. Prior peripheral artery (excluding carotid) revascularisation procedure iv. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis).

Exclusion Criteria

  • Clinical evidence of, or suspicion of, active infection at the discretion of the investigator. - Myocardial infarction, stroke, hospitalisation for unstable angina pectoris, or transient ischaemic attack within 60 days prior to randomisation (visit 2). - Planned coronary, carotid or peripheral artery revascularisation known on the day of randomisation (visit 2). - Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2).

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ziltivekimab 		Participants will receive 15 milligrams (mg) of either Ziltivekimab B or Ziltivekimab C subcutaneously using single-use pre-filled DV3430-C1 manual syringe or single-dose DV3430-C3 pen-injector respectively once monthly for up to 4 years.
  • Drug: Ziltivekimab B
    Administered subcutaneously (s.c., under skin) once-monthly using single-use pre-filled DV3430-C1 manual syringe and added to standard of care.
  • Drug: Ziltivekimab C
    Administered subcutaneously (s.c., under skin) once-monthly using single-dose DV3430-C3 pen-injector and added to standard of care.
Placebo Comparator
Placebo 		Participants will receive 15 mg of either placebo (Ziltivekimab B) or placebo (Ziltivekimab C) subcutaneously using single-use pre-filled DV3430-C1 manual syringe or single-dose DV3430-C3 pen-injector respectively once monthly for up to 4 years.
  • Drug: Placebo (Ziltivekimab B)
    Administered subcutaneously (s.c., under skin) once-monthly using single-use pre-filled DV3430-C1 manual syringe and added to standard of care.
  • Drug: Placebo (Ziltivekimab C)
    Administered subcutaneously (s.c., under skin) once-monthly using single-dose DV3430-C3 pen-injector and added to standard of care.

Recruiting Locations

Uni of Alabama at Birmingham
Birmingham, Alabama 35294

Healthscan Clinical Trials,LLC.
Montgomery, Alabama 36106

Aventiv Research Inc.
Mesa, Arizona 85206

Unity Health-Searcy Medical Center
Searcy, Arkansas 72143

National Heart Institute Cal
Beverly Hills, California 90211

Valley Clinical Trials
Covina, California 91723

Valiance Clinical Research
Huntington Park, California 90250

Balboa Nephro Med Gr Inc LaMes
La Mesa, California 91942

First Valley Medical Group
Lancaster, California 93534

VA Loma Linda Hlthcr Sys
Loma Linda, California 92357

Pacific Clinical Studies
Los Alamitos, California 90720

Angel City Research, Inc.
Los Angeles, California 90010

North America Research Institute
Lynwood, California 90262

Hoag Medical Group
Newport Beach, California 92663

Valley Clinical Trials, Inc.
Northridge, California 91325

Desert Oasis Hlthcr Med Group
Palm Springs, California 92262

Riverside Nephrology Physicians
Riverside, California 92503

N America Res Inst - San Dimas
San Dimas, California 91773

Lundquist Inst-Biomed Innovtn
Torrance, California 90502

Bridgeport Hospital
Bridgeport, Connecticut 06610

VA-Connecticut (VACHS)
West Haven, Connecticut 06516

The George Washington University Medical Center
Washington, District of Columbia 20037

Excel Med Ctr Clinical Trials
Boca Raton, Florida 33434

Innovative Research of W Florida Inc.
Clearwater, Florida 33756

Florida Premier Cardiology
Delray Beach, Florida 33445

Northeast Research Institute
Fleming Island, Florida 32003

Encore Medical Research LLC
Hollywood, Florida 33021

Elixia Pines
Hollywood, Florida 33024

Northeast Research Institute
Jacksonville, Florida 32204

Est Cst Inst for Rsrch,Jksnvil
Jacksonville, Florida 32216

Baptist Heart Specialists
Jacksonville, Florida 32258

San Marcus Res Clin Miami Lakes
Miami Lakes, Florida 33014

Life Spring Research
Miami, Florida 33130

Office of Kenneth Blaze DO
Miramar, Florida 33027

Suncoast Clinical Research, Inc.
Palm Harbor, Florida 34684

Hanson Clinical Research Center
Port Charlotte, Florida 33952

Peace River Cardiovascular Center
Port Charlotte, Florida 33952

Northeast Research Institute
Saint Augustine, Florida 32080

St Johns Center For Clinical Research
Saint Augustine, Florida 32086

Clinical Research of Central Florida_Winter Haven
Winter Haven, Florida 33880

Javara/Privia Med Grp GA,LLC
Albany, Georgia 31707

Southeastern Clinical Research Institute, LLC
Augusta, Georgia 30904

Hope Clin Res & Wellness
Conyers, Georgia 30094

Javara Inc._Albany
Fayetteville, Georgia 30214

NSC Research, Inc
Johns Creek, Georgia 30024

Endo Res Solutions Inc
Roswell, Georgia 30076

Javara Inc._Winston Salem
Savannah, Georgia 31406

Northwest Heart Clinical Research, LLC
Arlington Heights, Illinois 60005

Research by Design LLC
Chicago, Illinois 60643

Clinical Invest Special_Gurnee
Gurnee, Illinois 60031

Chicago Medical Research LLC
Hazel Crest, Illinois 60429

NorthShore Univ Hlth Sys
Skokie, Illinois 60077

Central Illinois Diabetes and Clinical Research
Springfield, Illinois 62711

MediSphere Medical Research Center, LLC
Evansville, Indiana 47714

Velocity Clin. Res Valparaiso
Valparaiso, Indiana 46383

Midwest Heart & Vasc Spec
Overland Park, Kansas 66211

Cotton O'Neil Clin Research Ctr
Topeka, Kansas 66606

The Research Group of Lexington LLC
Lexington, Kentucky 40503

Grace Research, LLC
Bossier City, Louisiana 71111

Clinical Trials of Ame, LLC
Monroe, Louisiana 71201

IMA Clinical Research
Monroe, Louisiana 71201

Grace Research, LLC_Shreveport
Shreveport, Louisiana 71105

Louisiana Heart Center_Slidell
Slidell, Louisiana 70458

John P Hakim MD and Associates
Clinton, Maryland 20735

Brigham & Women's Hospital
Boston, Massachusetts 02115-5804

Pentucket Medical Associates
Haverhill, Massachusetts 01830

Henry Ford Hospital_Detroit
Detroit, Michigan 48202

Elite Research Center
Flint, Michigan 48532

Healthy Heart Cardiology
Grand Rapids, Michigan 49546

McLaren Northern Michigan Hospital
Petoskey, Michigan 49770

AHS dba Abbot NW Hosp Diab Cen
Minneapolis, Minnesota 55407

University of Minnesota_Minneapolis_1
Minneapolis, Minnesota 55455

Clinical Research Consultants, LLC
Kansas City, Missouri 64111

St Louis Heart & Vascular, P.C.
Saint Louis, Missouri 63136

Nebraska Heart Institute_Lincoln
Lincoln, Nebraska 68526

Univ of Nebraska Medical CTR
Omaha, Nebraska 68198-3020

University of Nevada School of Medicine
Las Vegas, Nevada 89102

Palm Research Center Inc-Vegas
Las Vegas, Nevada 89128

Advanced Heart Care LLC
Bridgewater, New Jersey 08807-3064

Uni of New Mexico-Clinical
Albuquerque, New Mexico 87106

NYU Nephrology Associates
Mineola, New York 11501

NYU Grossman School of Med
New York, New York 10016

Mount Sinai Hosp at NYC
New York, New York 10019

Mattoo & Bhat Medical Associates, PC
Ridgewood, New York 11385

Saratoga Clinical Research
Saratoga Springs, New York 12866

Southgate Medical Group, LLP
West Seneca, New York 14224

Great Lakes Medical Research
Westfield, New York 14787

Mountain Kidney & Hypertension Associates
Asheville, North Carolina 28801

UNC- Chapel Hill
Chapel Hill, North Carolina 27599

Metrolina Nephrology Associates, PA
Charlotte, North Carolina 28208

Javara Inc._Charlotte
Charlotte, North Carolina 28210

PharmQuest Life Sciences LLC
Greensboro, North Carolina 27408

Physicians East Endocrinology
Greenville, North Carolina 27834

Carteret Medical Group
Morehead City, North Carolina 28557

Lillestol Research LLC
Fargo, North Dakota 58104

University of Cincinnati Medical Center (UCMC)
Cincinnati, Ohio 45219

VA Northeast Ohio Healthcare System (VANEOHS)
Cleveland, Ohio 44106

Advanced Med Res Maumee
Maumee, Ohio 43537

Northeast Clinical Research Center
Bethlehem, Pennsylvania 18017

Aria Endocrine Metabolic Assoc
Philadelphia, Pennsylvania 19114

Piedmont Research Partners, LLC
Fort Mill, South Carolina 29707

Palmetto Clinical Research
Greenville, South Carolina 29615

Univ Diab & Endo Consultants
Chattanooga, Tennessee 37411

Balad Hlth Sys-Welmont CardCVA
Greeneville, Tennessee 37745

Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee 37934

Clinical Neuroscience Solutions
Memphis, Tennessee 38119

Cardiovascular Research of Knoxville, LLC
Powell, Tennessee 37849

Liberty Research Center
Arlington, Texas 76002

Arlington Family Res. Ctr Inc
Arlington, Texas 76012-4637

Novel Research LLC
Bellaire, Texas 77401

Osvaldo A. Brusco MD PA
Corpus Christi, Texas 78414

Research Trials Worldwide LLC
Cypress, Texas 77429

Thyroid Endocrinology & Diabetes PA
Dallas, Texas 75208

Liberty Research Center_Dallas
Dallas, Texas 75230

Renal Disease Research Institute
Dallas, Texas 75235

Academy of Diabetes, Thyroid & Endocrine, P.A.
El Paso, Texas 79935

Care United Research, LLC
Forney, Texas 75126

Diabetes and Thyroid Ctr of FW
Fort Worth, Texas 76132

Javara /TX.Hlth LLC dba Prvia
Fort Worth, Texas 76133

PrimeCare Medical Group
Houston, Texas 77024

Baylor College Of Medicine_Houston
Houston, Texas 77030

Biopharma Informatic_Houston
Houston, Texas 77043

Prolato Clinical Research Center
Houston, Texas 77054

Cardiovasc Spec of Willowbrook
Houston, Texas 77070

PlanIt Research, PLLC
Houston, Texas 77079

Biopharma Informatic, LLC
Houston, Texas 77084

DCOL Ctr for Clin Res
Longview, Texas 75605

Texas Inst, Kdny & Endo Disor
Lufkin, Texas 75904

RGV Endocrine Center
McAllen, Texas 78503

Texas Diabetes Institute
San Antonio, Texas 78207-5209

Clinical Advancement Ctr, PLLC
San Antonio, Texas 78212

Sun Research Institute
San Antonio, Texas 78215

VIP Trials
San Antonio, Texas 78230

NE Clin Res of San Antonio
San Antonio, Texas 78233

Javara Privia Grp Gulf Cst LLC
San Marcos, Texas 78666

Simcare Medical Research, LLC
Sugar Land, Texas 77478

Hillcrest Family Health Center
Waco, Texas 76708

York Clinical Research LLC
Norfolk, Virginia 23504

Virginia Commonwealth University Health System
Richmond, Virginia 23298

VA Medical Center_Salem
Salem, Virginia 24153-6404

Selma Medical Associates
Winchester, Virginia 22601-3834

Providence Medical Research Center
Spokane, Washington 99204

Aspirus Research Institute
Wausau, Wisconsin 54401

More Details

NCT ID
NCT05021835
Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

Novo Nordisk
(+1) 866-867-7178
clinicaltrials@novonordisk.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.