Ziltivekimab

DRUG14 trials

Sponsors

Novo Nordisk A/S, Novo Nordisk A/S, ECRI-trials B.V., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), ECRI bv

Conditions

Acute Myocardial Infarction (AMI)Acute myocardial infarctionAtherosclerosisAtherosclerotic cardiovascular diseaseCardiovascular RiskChronic Kidney DiseaseChronic Kidney Disease and Systemic InflammationChronic Kidney Diseases

Phase 1

A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With Kidney Disease and Inflammation

CompletedNCT05379829

Novo Nordisk A/SChronic Kidney Disease and Systemic Inflammation

Start: 2022-05-30End: 2024-09-02Updated: 2025-12-31

Phase 2

Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition

CompletedNCT03926117

Novo Nordisk A/SChronic Kidney Diseases, Inflammation

Start: 2019-06-03End: 2020-06-26Updated: 2025-12-31

Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition in Japan.

CompletedNCT04626505

Novo Nordisk A/SCardiovascular Risk, Chronic Kidney Disease, Inflammation

Start: 2020-10-22End: 2021-09-28Updated: 2026-05-06

Phase 3

A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

TerminatedNCT05636176

Novo Nordisk A/SHeart Failure

Start: 2023-05-08End: 2026-09-03Updated: 2026-09-10

HERMES: Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation

Active, not recruitingCTIS2022-501939-16-00

Novo Nordisk A/SHeart failure (HF) with mildly reduced ejection fraction (HFmrEF) or HF with preserved ejection fraction (HFpEF) and systemic inflammation.

Start: 2023-05-09Target: 2219Updated: 2026-01-26

ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack

Active, not recruitingNCT06118281

Novo Nordisk A/SAcute Myocardial Infarction (AMI), Cardiovascular Risk

Start: 2024-06-25End: 2027-01-29Target: 10000Updated: 2026-09-09

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

Active, not recruitingNCT06200207

Novo Nordisk A/SHeart Failure, Systemic Inflammation

Start: 2024-04-01End: 2027-01-08Target: 680Updated: 2026-09-01

Specifying the Anti-inflammatory Effects of Ziltivekimab

Active, not recruitingNCT06263244

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Atherosclerosis, Inflammation

Start: 2024-05-03End: 2026-10-30Target: 40Updated: 2026-08-06

ATHENA: Effects of ziltivekimab versus placebo on heart failure symptoms and physical function in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation

Active, not recruitingCTIS2023-506988-34-00

Novo Nordisk A/SHeart failure with mildly reduced or preserved ejection fraction and systemic inflammation

Start: 2024-03-27Target: 318Updated: 2026-01-23

ZEUS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation

Active, not recruitingCTIS2023-506926-35-00

Novo Nordisk A/SAtherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation

Start: 2021-09-24Target: 2335Updated: 2025-11-10

ARTEMIS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in patients with acute myocardial infarction.

Active, not recruitingCTIS2023-506876-28-00

Novo Nordisk A/Sand currently available clinical data support that ziltivekimab once-monthly reduces inflammation as measured by highsensitivity C-reactive protein (hs-CRP). With the recent proof-of-concept that hs-CRP reduction through inhibition of an upstream pathway leads to reduction in cardiovascular events, it is reasonable to expect that similar inhibition of IL-6 with ziltivekimab also reduces CV risk.The aim of the current study is to demonstrate the efficacy and safety of ziltivekimab in reducing the risk of major adverse cardiovascular events when initiated as early as possible in adult patients with ST-elevation and non-ST-elevation myocardial infarction, The medical condition we are investigating is type 1 AMI (STEMI and NSTEMI). Ziltivekimab is a human monoclonal antibody directed against the interleukin-6 (IL-6) ligand

Start: 2024-08-01Target: 3925Updated: 2025-09-22

ARTEMIS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in patients with acute myocardial infarction.

Active, not recruitingCTIS2023-506876-28-00

Novo Nordisk A/Sand currently available clinical data support that ziltivekimab once-monthly reduces inflammation as measured by highsensitivity C-reactive protein (hs-CRP). With the recent proof-of-concept that hs-CRP reduction through inhibition of an upstream pathway leads to reduction in cardiovascular events, it is reasonable to expect that similar inhibition of IL-6 with ziltivekimab also reduces CV risk.The aim of the current study is to demonstrate the efficacy and safety of ziltivekimab in reducing the risk of major adverse cardiovascular events when initiated as early as possible in adult patients with ST-elevation and non-ST-elevation myocardial infarction, The medical condition we are investigating is type 1 AMI (STEMI and NSTEMI). Ziltivekimab is a human monoclonal antibody directed against the interleukin-6 (IL-6) ligand

Start: 2024-08-01Target: 3925Updated: 2025-09-22

Effects of ziltivekimab versus placebo on coronary atherosclerosis in patients with acute myocardial infarction. A serial, multivessel, intravascular ultrasound, near-infrared spectroscopy and optical coherence tomography imaging study

Not yet recruitingCTIS2024-520364-34-00

Novo Nordisk A/S, ECRI-trials B.V.Acute myocardial infarction

Target: 249Updated: 2026-01-19

Effects of Ziltivekimab on Coronary Atherosclerotic Burden in Patients With Acute Myocardial Infarction

RecruitingNCT07276282

ECRI bvAcute Myocardial Infarction (AMI), Coronary Artery Disease, Coronary Atherosclerosis of Native Coronary Artery

Start: 2025-12-19End: 2028-12-01Target: 332Updated: 2026-03-23

A Research Study to Look at the Effect of Ziltivekimab on Plaque in the Blood Vessels of the Heart, Compared to Placebo, in People With a Heart Attack

RecruitingNCT07301034

Novo Nordisk A/SMyocardial Infarction

Start: 2025-12-18End: 2029-02-24Target: 332Updated: 2026-03-11

Related Papers

Effect of Ziltivekimab on Determinants of Hemoglobin in Patients with CKD Stage 3–5: An Analysis of a Randomized Trial (RESCUE)

Journal of the American Society of Nephrology2023-12-1318 citations

Colchicine in patients with heart failure and preserved left ventricular ejection fraction: rationale and design of a prospective, randomised, open-label, crossover clinical trial

Open Heart2023-08-0112 citations

Efficacy and safety of interleukin-6 inhibition with ziltivekimab in patients at high risk of atherosclerotic events in Japan (RESCUE-2): A randomized, double-blind, placebo-controlled, phase 2 trial

Journal of Cardiology2023-05-1941 citations

IL-6 inhibition with ziltivekimab in patients at high atherosclerotic risk (RESCUE): a double-blind, randomised, placebo-controlled, phase 2 trial.

2021-05-17460 citations