ZEUS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Participants With Established Atherosclerotic Cardiovascular Disease, Chronic Kidney Disease and Systemic Inflammation
ZEUS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Participants With Established Atherosclerotic Cardiovascular Disease, Chronic Kidney Disease and Systemic Inflammation
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.
Inclusion Criteria:
Chronic kidney disease defined by one of the below:
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:
CABA, Buenos Aires C1128 AAF, Argentina
CABA, Buenos Aires C1213, Argentina
CABA, Buenos Aires C1428ART, Argentina
CABA, Buenos Aires C1440CFD, Argentina
Mar del Plata, Buenos Aires B7600GNY, Argentina
CABA, C1120AAC, Argentina
Capital Federal, C1431FWO, Argentina
Ciudad Autónoma de Buenos Aire, 1425, Argentina
Quilmes - Buenos Aires, B1878DVB, Argentina
San Miguel de Tucumán, Tucumán., T4000, Argentina
St Albans, Victoria 3021, Australia
Traralagon, Victoria 3844, Australia
Vitória, Espírito Santo 29055-450, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
Porto Alegre/ RS, 90035-074, Brazil
São Bernardo Do Campo/SP, 09715-090, Brazil
São Paulo - SP, 04038-002, Brazil
North York, Ontario M6B 3H7, Canada
Beijing, Beijing Municipality 100853, China
Chongqing, Chongqing Municipality 402260, China
Lanzhou, Gansu 730030, China
Lanzhou, Gansu 730030, China
Huizhou, Guangdong 516001, China
Shantou, Guangdong 515065, China
Nanning, Guangxi 530016, China
Luoyang, Henan 471003, China
Xinxiang, Henan 453000, China
Changde, Hunan 415003, China
Nanning, Jiangsu 530016, China
Dalian, Liaoning 116033, China
Dalian, Liaoning 116033, China
Jinzhou, Liaoning 121012, China
Xi'an, Shaanxi 710061, China
Jinan, Shandong 250013, China
Shanghai, Shanghai Municipality 200092, China
Shanghai, Shanghai Municipality 200233, China
Shanghai, Shanghai Municipality 201199, China
Hangzhou, Zhejiang 310003, China
Hangzhou, 310003, China
Shantou, 515065, China
Krapinske Toplice, Krapinsko Zagorska County 49217, Croatia
Holbæk, Region Sjælland 4300, Denmark
Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany
Karlsbad, Baden-Wurttemberg 76307, Germany
Oldenburg in Holstein, Holstein 23758, Germany
Coburg, Thuringia 96450, Germany
Berlin, 12203, Germany
Homburg Saar, 66421, Germany
Haidari-Athens, Attica GR-12462, Greece
Pylea, Thessaloniki, 57001, Greece
Rio, Patra, 26504, Greece
Békéscsaba, Bekes County 5600, Hungary
Hyderabad, Andhra Pradesh 500082, India
New Delhi, National Capital Territory of Delhi 110002, India
New Delhi, National Capital Territory of Delhi 110025, India
New Delhi, National Capital Territory of Delhi 110062, India
New Dehli, New Delhi 110029, India
Hyderbad, Telangana 500 012, India
Chandigarh, 160012, India
Milan, 20132, Italy
Palermo, 90127, Italy
Uwajima-shi, Ehime 798-8510, Japan
Uwajima-shi, Ehime 798-8510, Japan
Koriyama-shi, Fukushima, Fukushima, Japan 963-8851, Japan
Koriyama-shi, Fukushima, Japan 963-8851, Japan
Bunkyo-ku, Tokyo, 113-8603, Japan
Bunkyo-ku, Tokyo, 113-8655, Japan
Chiba-shi, Chiba, 260-0804, Japan
Chikushino-shi, Fukuoka, 818-8516, Japan
Chuo-city, Yamanashi, 409-3898, Japan
Fukuoka-shi, Fukuoka, 810-0001, Japan
Fukuoka-shi, Fukuoka, 814-0133, Japan
Hamamatsu-shi, Shizuoka, 430-0929, Japan
Kishiwada, Osaka, 596-0042, Japan
Koga-shi, Fukuoka, 811-3195, Japan
Kumamoto-shi, Kumamoto, 860-8556, Japan
Kyoto-shi, Kyoto, 607-8062, Japan
Kyoto-shi, Kyoto, 607-8062, Japan
Kyoto-shi, Kyoto, 612-8555, Japan
Kyoto-shi,Kyoto, 601-1495, Japan
Matsudo-shi, 270-2251, Japan
Minato-ku, Tokyo, 108-0073, Japan
Morioka-shi, Iwate, 020-0066, Japan
Morioka-shi, Iwate, 020-0066, Japan
Nagoya-shi, Aichi, 457-0818, Japan
Nagoya-shi, Aichi, 466-8560, Japan
Naha-shi, Okinawa, 902-8511, Japan
Naha-shi, Okinawa, 902-8511, Japan
Nara-shi, Nara, 630-8581, Japan
Nara-shi, Nara, 630-8581, Japan
Nishinomiya-shi, Hyogo, 663-8241, Japan
Oita-shi, Oita, 870-0263, Japan
Osaka-city, Osaka, 530-0005, Japan
Osaka-shi, Osaka, 533-0024, Japan
Osaka-shi, Osaka, 534-0021, Japan
Osaka-shi, Osaka, 538-0044, Japan
Osaka-shi,Osaka, 559-0012, Japan
Ota-shi, Gunma, 373-8585, Japan
Ota-shi, Gunma, 373-8585, Japan
Sagamihara-shi, Kanagawa, 252-0392, Japan
Sagamihara-shi, Kanagawa, 252-0392, Japan
Sendai-shi, Miyagi, 980-8574, Japan
Sendai-shi, Miyagi, 981-3133, Japan
Sendai-shi, Miyagi, 983-0039, Japan
Sendai-shi, Miyagi, 983-0039, Japan
Tachikawa-shi, Tokyo, 190-0014, Japan
Takamatsu-shi, Kagawa, 760-0017, Japan
Takamatsu-shi, Kagawa, 760-8557, Japan
Tsukuba-shi, Ibaraki, 305-8558, Japan
Yokohama-shi, Kanagawa, 234-0054, Japan
Yokohama-shi, Kanagawa, 236-0004, Japan
Cheras, Kuala Lumpur 56000, Malaysia
Lembah Pantai, Kuala Lumpur 59100, Malaysia
Ipoh, Perak, 30450, Malaysia
San Luis Potosí City, San Luis Potosí 78200, Mexico
Culiacán, Sinaloa 80230, Mexico
Wroclaw, Lower Silesian Voivodeship 50-981, Poland
Gorzów Wielkopolski, Lubusz Voivodeship 66-400, Poland
Bialystok, Podlaskie Voivodeship 15-540, Poland
Gdynia, Pomeranian Voivodeship 81-157, Poland
Elblag, 82-300, Poland
Grodzisk Mazowiecki, 05-825, Poland
Tychy, 43-100, Poland
Węgrów, 07-100, Poland
Lodz, Łódź Voivodeship 90-549, Poland
Carnaxide, Lisbon District 2790-134, Portugal
Senhora Da Hora, Matosinhos, Matosinhos 4464-513, Portugal
Guilhufe - Penafiel, 4560-136, Portugal
Lisbon, 1449-005, Portugal
Bucharest, Bucurestii 020475, Romania
Bucharest, 020475, Romania
Kragujevac, 34000, Serbia
George, Eastern Cape 6529, South Africa
Paarl, Cape Town, Western Cape 7646, South Africa
Gangwon-do, 26426, South Korea
L' Hospitalet Del Llobregat, 08907, Spain
Istanbul, Bakirkoy 34098, Turkey (Türkiye)
Afyonkarahisar, 03200, Turkey (Türkiye)
Kharkiv, 61039, Ukraine
Kyiv, 03151, Ukraine
Kyiv, 03680, Ukraine
Zaporizhia, 69001, Ukraine
Zaporizhzhya, 69063, Ukraine
Dorset, BH16 5PW, United Kingdom