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- |||| ziltivekimab (COR-001) / Novo Nordisk
Trial completion date, Trial primary completion date: ATHENA: A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation (clinicaltrials.gov) - Jan 4, 2025
P3, N=680, Recruiting, Sponsor: Novo Nordisk A/S
Trial completion date: Sep 2026 --> Jan 2027 | Trial primary completion date: Jun 2026 --> Oct 2026
- || ziltivekimab (COR-001) / Novo Nordisk
Review, Journal: "Anti-inflammatory Therapies in Atherosclerosis - Where are we going?". (Pubmed Central) - Dec 19, 2024
Colchicine is by far the only one that has the potential to be widely used due to its cost-effectiveness. Further research is needed on other novel anti-inflammation therapies and their real-world implementation.
- ziltivekimab (COR-001) / Novo Nordisk
Design of the ZEUS Trial: Interleukin-6 Inhibition With Ziltivekimab for Cardiovascular Protection in Chronic Kidney Disease (Auditorium Brahmkamal Hall) - Dec 19, 2024 - Abstract #ISNWCN2025ISN_WCN_482;
- |||||| ziltivekimab (COR-001) / Novo Nordisk
Enrollment open: ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack (clinicaltrials.gov) - Nov 15, 2024
P3, N=10000, Recruiting, Sponsor: Novo Nordisk A/S
Further research is needed on other novel anti-inflammation therapies and their real-world implementation. Not yet recruiting --> Recruiting
- || ziltivekimab (COR-001) / Novo Nordisk
Review, Journal: Ziltivekimab for anemia and atherosclerosis in chronic kidney disease: a new hope? (Pubmed Central) - Oct 25, 2024
In addition, ziltivekimab has shown efficacy in improving anemia parameters, including hemoglobin levels and iron studies. Ziltivekimab deserves full scale clinical development, and to this aim, large-scale clinical trials are under way.
- || ziltivekimab (COR-001) / Novo Nordisk, Ilaris (canakinumab) / Novartis
Review, Journal: Recent Advances in Targeted Management of Inflammation In Atherosclerosis: A Narrative Review. (Pubmed Central) - Jul 20, 2024
Evidence suggests that high-sensitivity C-reactive protein (hsCRP), and potentially other inflammatory biomarkers, can be used to identify the inflammatory residual ASCVD risk phenotype and may serve as future targets for the development of more efficacious therapeutic approaches. We review the biological basis for the association of inflammation with ASCVD, propose new therapeutic strategies for the use of inflammation-targeted treatments, and discuss current challenges in the implementation of this new treatment paradigm for ASCVD.
- ziltivekimab (COR-001) / Novo Nordisk
Direct IL-6 inhibition prevents arterial thrombosis by reducing collagen-mediated platelets activation (Station 9 - Research Gateway) - May 14, 2024 - Abstract #ESC2024ESC_4141;
The direct inhibition of IL-6 reduces platelets reactivity to collagen, thereby blunting arterial thrombosis upon endothelial damage. These results provide a potential mechanism to explain the reduction of cardiovascular risk associated to direct IL-6 inhibition.
- |||||| ziltivekimab (COR-001) / Novo Nordisk
Enrollment open: ATHENA: A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation (clinicaltrials.gov) - Apr 24, 2024
P3, N=680, Recruiting, Sponsor: Novo Nordisk A/S
These results provide a potential mechanism to explain the reduction of cardiovascular risk associated to direct IL-6 inhibition. Not yet recruiting --> Recruiting
- || ziltivekimab (COR-001) / Novo Nordisk, Ilaris (canakinumab) / Novartis
Retrospective data, Review, Journal: Impacts of pro-inflammatory cytokines variant on cardiometabolic profile and premature coronary artery disease: A systematic review and meta-analysis. (Pubmed Central) - Apr 22, 2024
In summary, rs1800795 had a slight but significant impact on cardiometabolic risk factors and PCAD. IL-6 inhibition with ziltivekimab or canakinumab may benefit high-risk populations (e.g. brown race population, Caucasians, obese patients, etc.) with rs1800795 to prevent PCAD.
- ||| ziltivekimab (COR-001) / Novo Nordisk
Trial completion date: ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation (clinicaltrials.gov) - Apr 4, 2024
P3, N=6200, Recruiting, Sponsor: Novo Nordisk A/S
IL-6 inhibition with ziltivekimab or canakinumab may benefit high-risk populations (e.g. brown race population, Caucasians, obese patients, etc.) with rs1800795 to prevent PCAD. Trial completion date: Oct 2025 --> Jan 2026
- ziltivekimab (COR-001) / Novo Nordisk, Ilaris (canakinumab) / Novartis
Status and Prospect of Anti-Inflammatory Therapeutic Pathway for Coronary Heart Disease () - Mar 8, 2024 - Abstract #ISPOR2024ISPOR_1360;
pathway inhibitors in the future. If successful, These trials will usher in a new era in which anti-inflammatory therapy is included as the standard of care for chronic coronary syndromes.
- | ziltivekimab (COR-001) / Novo Nordisk
Journal: C-reactive protein, pharmacological treatments and diet: how to target your inflammatory burden. (Pubmed Central) - Jan 26, 2024
Whilst advances in the field of specific anti-inflammatory treatments have been made over the last years, their broad implementation is currently limited. Therefore, optimization of diet (and other lifestyle factors) could provide a cost effective and side-effect free intervention to target low-grade vascular inflammation.
- ||| ziltivekimab (COR-001) / Novo Nordisk
Trial completion: A Research Study Looking Into Blood Levels of Three Different Formulations of the Study Medicine Ziltivekimab (clinicaltrials.gov) - Jan 11, 2024
P1, N=267, Completed, Sponsor: Novo Nordisk A/S
Therefore, optimization of diet (and other lifestyle factors) could provide a cost effective and side-effect free intervention to target low-grade vascular inflammation. Active, not recruiting --> Completed
- |||||||||| ziltivekimab (COR-001) / Novo Nordisk
New P3 trial: ATHENA: A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation (clinicaltrials.gov) - Jan 11, 2024
P3, N=680, Not yet recruiting, Sponsor: Novo Nordisk A/S
- | ziltivekimab (COR-001) / Novo Nordisk
Biomarker, Journal: Effect of Ziltivekimab on Determinants of Hemoglobin in Patients with CKD Stage 3-5: An Analysis of a Randomized Trial (RESCUE). (Pubmed Central) - Jan 4, 2024
P2b
Active, not recruiting --> Completed Anti-inflammatory therapy with ziltivekimab improved the markers of anemia and iron homeostasis in people with stage 3-5 CKD and systemic inflammation, suggesting a possible role in anemia management.
- || ziltivekimab (COR-001) / Novo Nordisk, Ilaris (canakinumab) / Novartis
Review, Journal: An Update on Inflammation in Atherosclerosis: How to Effectively Treat Residual Risk. (Pubmed Central) - Nov 27, 2023
(Clin Ther. 2023;45:XXX-XXX)
- | ziltivekimab (COR-001) / Novo Nordisk
Trial primary completion date: A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With Kidney Disease and Inflammation (clinicaltrials.gov) - Nov 13, 2023
P1, N=24, Active, not recruiting, Sponsor: Novo Nordisk A/S
2023;45:XXX-XXX) Trial primary completion date: Jul 2023 --> May 2024
- |||||||||| ziltivekimab (COR-001) / Novo Nordisk
New P3 trial: ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack (clinicaltrials.gov) - Nov 7, 2023
P3, N=10000, Not yet recruiting, Sponsor: Novo Nordisk A/S
- || ziltivekimab (COR-001) / Novo Nordisk
Enrollment closed: A Research Study Looking Into Blood Levels of Three Different Formulations of the Study Medicine Ziltivekimab (clinicaltrials.gov) - Oct 19, 2023
P1, N=267, Active, not recruiting, Sponsor: Novo Nordisk A/S
Trial primary completion date: Jul 2023 --> May 2024 Recruiting --> Active, not recruiting
- || ziltivekimab (COR-001) / Novo Nordisk
New P2 trial: Impact of inflammation lowering on plaques and systemic inflammation Impact van ontsteking verlaging op plaques en systemische ontsteking (EUDRACT) - Aug 22, 2023
P2, N=40, Ongoing, Sponsor: Academic Medical Center (AMC), department of Internal Medicine
- ziltivekimab (COR-001) / Novo Nordisk
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 (Exhibit Hall) - Jul 18, 2023 - Abstract #HFSA2023HFSA_104;
- ||| ziltivekimab (COR-001) / Novo Nordisk
Clinical: I am much more excited by the ~90% reduction in CRP with ziltivekimab. If anti-inflammatory therapy reduces CV risk, we should see a very important clinical effect in a high risk population with few options. The discussion about Lp(a) here is reminiscent of CRP effects of statins (Twitter) - Jul 16, 2023
- ||||| colchicine / Generic mfg., ziltivekimab (COR-001) / Novo Nordisk
Clinical: Paul Ridker: Colchicine greatly lowers inflammatory risk for CVD but shouldn’t be given to pts with chronic #kidneydisease; ziltivekimab may fill that gap if the ZEUS trial succeeds @HeartinDiabetes #HiD2023 @YHandelsmanMD @Nephronline #CardioTwitter (Twitter) - Jun 11, 2023
- |||||| ziltivekimab (COR-001) / Novo Nordisk
Enrollment open: HERMES: A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation (clinicaltrials.gov) - May 25, 2023
P3, N=5600, Recruiting, Sponsor: Novo Nordisk A/S
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | ziltivekimab (COR-001) / Novo Nordisk
Trial completion date: A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With Kidney Disease and Inflammation (clinicaltrials.gov) - May 18, 2023
P1, N=24, Active, not recruiting, Sponsor: Novo Nordisk A/S
Not yet recruiting --> Recruiting Trial completion date: Jul 2023 --> May 2024
- |||| ziltivekimab (COR-001) / Novo Nordisk
RESCUE trial showed that IL-6 inhibition with ziltivekimab also reduced Lp(a) levels. Zeus ⚡️will help us to understand better this topic (Twitter) - Mar 24, 2023
- ||| ziltivekimab (COR-001) / Novo Nordisk
Enrollment open: A Research Study Looking Into Blood Levels of Three Different Formulations of the Study Medicine Ziltivekimab (clinicaltrials.gov) - Mar 2, 2023
P1, N=267, Recruiting, Sponsor: Novo Nordisk A/S
Trial completion date: Jul 2023 --> May 2024 Not yet recruiting --> Recruiting
- ||| ziltivekimab (COR-001) / Novo Nordisk
New P1 trial: A Research Study Looking Into Blood Levels of Three Different Formulations of the Study Medicine Ziltivekimab (clinicaltrials.gov) - Feb 10, 2023
P1, N=267, Not yet recruiting, Sponsor: Novo Nordisk A/S
- ||| obicetrapib (TA-8995) / NewAmsterdam Pharma, Menarini, ziltivekimab (COR-001) / Novo Nordisk, Mounjaro (tirzepatide) / Eli Lilly
The inaugural Pipeline Pulse column by @SethJBaumMD appears in our January issue, online now. Learn more about #tirzepatide, #ziltivekimab and #obicetrapib https://t.co/pQVt4wfyXq #CardioTwitter #Cardiology @LillyPad @novonordiskus @NewAmsPharma (Twitter) - Jan 18, 2023
- |||||||||| ziltivekimab (COR-001) / Novo Nordisk
New P3 trial: HERMES: A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation (clinicaltrials.gov) - Dec 5, 2022
P3, N=5600, Not yet recruiting, Sponsor: Novo Nordisk A/S
- | ziltivekimab (COR-001) / Novo Nordisk
Journal: Association of Interleukin 6 Inhibition With Ziltivekimab and the Neutrophil-Lymphocyte Ratio: A Secondary Analysis of the RESCUE Clinical Trial. (Pubmed Central) - Dec 1, 2022
Results of this post hoc analysis of the RESCUE trial show that IL-6 ligand inhibition with ziltivekimab associates with a lower NLR, suggesting that it may disrupt multiple atherogenic inflammatory pathways, including those mediated by the myeloid cell compartment. The NLR may have use in monitoring ziltivekimab's efficacy should it be introduced into clinical practice.
- ||| NNC6019 / Novo Nordisk, ziltivekimab (COR-001) / Novo Nordisk
Novo Nordisk's #cardiovascular charge continues (via @ByMadeleineA) https://t.co/HrvJmusYON $NVO #ESCCongress #ziltivekimab #PRX004 #amyloidosis #semaglutide #HS001 (Twitter) - Sep 1, 2022
- || ziltivekimab (COR-001) / Novo Nordisk
Enrollment closed: A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With Kidney Disease and Inflammation (clinicaltrials.gov) - Jun 24, 2022
P1, N=24, Active, not recruiting, Sponsor: Novo Nordisk A/S
The NLR may have use in monitoring ziltivekimab's efficacy should it be introduced into clinical practice. Not yet recruiting --> Active, not recruiting
- ziltivekimab (COR-001) / Novo Nordisk
The effect of ziltivekimab on the neutrophil-lymphocyte ratio: analysis from RESCUE (Research Gateway 4) - Jun 15, 2022 - Abstract #ESC2022ESC_4178;
The ongoing ZEUS cardiovascular (CV) outcomes trial will assess whether ziltivekimab can reduce CV event rates among individuals with stage 3 to 4 CKD, known atherosclerotic disease, and elevated hsCRP. If ziltivekimab reduces CV risk, it would provide further evidence for critical inter-relationships between bone marrow function and atherothrombosis.
- ziltivekimab (COR-001) / Novo Nordisk
Effects of interleukin-6 inhibition with ziltivekimab in patients at high risk of atherosclerotic events in Japan: results from the phase 2 RESCUE-2 trial (Research Gateway 6) - Jun 15, 2022 - Abstract #ESC2022ESC_1044;
A significant reduction of more than 90% in hsCRP levels for both doses of ziltivekimab was demonstrated, with a safety profile similar to placebo. Overall, the results of the RESCUE-2 trial in Japan are consistent with the efficacy and safety results of the US-based RESCUE trial.
- ||| ziltivekimab (COR-001) / Novo Nordisk
We are going on target in enrollment of #zeustrial in #Turkey #zeusinvestigators #ziltivekimab @LaleTokgozoglu #CardioTwitter @TKDsosyal #inflammation @fhscglobal @novonordisk (Twitter) - Jun 11, 2022
- || ziltivekimab (COR-001) / Novo Nordisk
New P1 trial: A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With Kidney Disease and Inflammation (clinicaltrials.gov) - May 17, 2022
P1, N=24, Not yet recruiting, Sponsor: Novo Nordisk A/S
- || Review, Journal: Targeting the Residual Cardiovascular Risk by Specific Anti-inflammatory Interventions as a Therapeutic Strategy in Atherosclerosis. (Pubmed Central) - Apr 14, 2022
This review aims to discuss novel therapeutic agents targeting inflammatory pathways in ASCVD in light of the canakinumab anti-inflammatory thrombosis outcomes study (CANTOS) trial results. Further we discuss the effects of different anti-inflammatory agents administered in patients with ASCVD and their potential to change clinical practice in preventive cardiology.
- || ziltivekimab (COR-001) / Novo Nordisk
Biomarker, Clinical, P1 data, Clinical Trial,Phase I, Journal: A Phase 1 Randomized Dose-Escalation Study of a Human Monoclonal Antibody to IL-6 in CKD. (Pubmed Central) - Apr 8, 2022
The mean t ranged from of 45 to 65 days. In adults with moderate-to-severe CKD and evidence of chronic inflammation, a single-injection of the IL-6 inhibitor ziltivekimab was safe and highly effective at suppressing hsCRP over 12 weeks.
- | ziltivekimab (COR-001) / Novo Nordisk
Journal: From RESCUE to ZEUS: will interleukin-6 inhibition with ziltivekimab prove effective for cardiovascular event reduction? (Pubmed Central) - Mar 1, 2022
In adults with moderate-to-severe CKD and evidence of chronic inflammation, a single-injection of the IL-6 inhibitor ziltivekimab was safe and highly effective at suppressing hsCRP over 12 weeks. No abstract available
- || ziltivekimab (COR-001) / Novo Nordisk
Clinical, P2 data, Journal: IL-6 inhibition with ziltivekimab in patients at high atherosclerotic risk (RESCUE): a double-blind, randomised, placebo-controlled, phase 2 trial. (Pubmed Central) - Jan 11, 2022
P2b
Ziltivekimab markedly reduced biomarkers of inflammation and thrombosis relevant to atherosclerosis. On the basis of these data, a large-scale cardiovascular outcomes trial will investigate the effect of ziltivekimab in patients with chronic kidney disease, increased high-sensitivity CRP, and established cardiovascular disease.
- | ziltivekimab (COR-001) / Novo Nordisk
Journal: Interleukin-6 Signaling and Anti-Interleukin-6 Therapeutics in Cardiovascular Disease. (Pubmed Central) - Jan 7, 2022
In this review, we provide an overview of the mechanisms by which IL-6 signaling occurs and how that impacts upon pharmacologic inhibition; describe murine models of IL-6 and atherogenesis; summarize human epidemiologic data outlining the utility of IL-6 as a biomarker of vascular risk; outline genetic data suggesting a causal role for IL-6 in systemic atherothrombosis and aneurysm formation; and then detail the potential role of IL-6 inhibition in stable coronary disease, acute coronary syndromes, heart failure, and the atherothrombotic complications associated with chronic kidney disease and end-stage renal failure. Finally, we review anti-inflammatory and anti-thrombotic findings for ziltivekimab, a novel IL-6 ligand inhibitor being developed specifically for use in atherosclerotic disease and poised to be tested formally in a large scale cardiovascular outcomes trial focused on individuals with chronic kidney disease and elevated levels of C-reactive protein, a population at high residual atherothrombotic risk, high residual inflammatory risk, and considerable unmet clinical need.
- || ziltivekimab (COR-001) / Novo Nordisk
Clinical: Yes! Currently in late-stage clinical development (ziltivekimab) by @novonordisk [Ph2 https://t.co/dCn9GLXPGW ; Ph3 planned https://t.co/sBeZCCCu62] (Twitter) - Dec 26, 2021
- || Actemra IV (tocilizumab) / Roche, JW Pharma
Review, Journal: The role and transformative potential of IL-19 in atherosclerosis. (Pubmed Central) - Dec 16, 2021
Several other drugs have also been investigated in clinical trials as anti-inflammatory agents; the development of some of these agents has been terminated (canakinumab, darapladib, varespladib, losmapimod, atreleuton, setileuton, PF-04191834, veliflapon, and methotrexate), but others remain in development (ziltivekimab, tocilizumab, Somalix, IFM-2427, anakinra, mesenchymal stem cells (MSCs), colchicine, everolimus, allopurinol, and montelukast)...We propose that IL-19 is a promising biomarker and target for the diagnosis and treatment of atherosclerosis. This review considers the role and mechanism of action of IL-19 in atherosclerosis and discusses whether IL-19 is a potential therapeutic target for this condition.
- |||| ziltivekimab (COR-001) / Novo Nordisk
P3 data: Getting started #ZEUStrial #ziltivekimab Phase3 CVOT #IL6inhibition 🤞🏽 @paulridker @VladoPerkovic @LaleTokgozoglu @novonordisk #CardioTwitter #inflammation @drpablocorral @pabeda1 (Twitter) - Dec 2, 2021
- || ziltivekimab (COR-001) / Novo Nordisk
Trial completion, Metastases: RESCUE-2: Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition in Japan. (clinicaltrials.gov) - Oct 27, 2021
P2, N=36, Completed, Sponsor: Novo Nordisk A/S
This review considers the role and mechanism of action of IL-19 in atherosclerosis and discusses whether IL-19 is a potential therapeutic target for this condition. Recruiting --> Completed
- | Ilaris (canakinumab) / Novartis
Journal: Anti-inflammatory therapy in ischaemic heart disease: from canakinumab to colchicine. (Pubmed Central) - Oct 20, 2021
In summary, canakinumab and colchicine have shown efficacy in preventing MACE in ischaemic heart disease patients, but only colchicine has acceptable safety (and cost) for use in secondary cardiovascular prevention. Clinical results are expected with the anti-IL6 ziltivekimab.
- ziltivekimab (COR-001) / Novo Nordisk
[VIRTUAL] IL-6 Inhibitor Ziltivekimab Increases Serum Hemoglobin and Iron Biomarkers in Patients with CKD Stage 3–5: A RESCUE Trial Analysis () - Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_1225;
P1/2, P2b
Conclusion Ziltivekimab improved levels of Hb, serum iron and other iron biomarkers vs PBO in pts with CKD stage 3–5. By reducing inflammation and improving functional iron deficiency, ziltivekimab may improve anemia in pts with CKD.
- |||||| ziltivekimab (COR-001) / Novo Nordisk
Enrollment open: ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation (clinicaltrials.gov) - Sep 27, 2021
P3, N=6200, Recruiting, Sponsor: Novo Nordisk A/S
By reducing inflammation and improving functional iron deficiency, ziltivekimab may improve anemia in pts with CKD. Not yet recruiting --> Recruiting
- || colchicine / Generic mfg., ziltivekimab (COR-001) / Novo Nordisk
Thanks, Augusto. This might offer an additional benefit to its anti-inflammatory action, though possibly modest, from what is known about the need for robust drops in Lp(a). Ziltivekimab, if successful in ZEUS, will probably come to market w/a very high cost. Now, colchicine...😉 (Twitter) - Sep 5, 2021