Ziltivekimab for Inflammation

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Novo Nordisk Investigational Site, Denmark Hill, London, United Kingdom
Inflammation+6 More
Ziltivekimab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation.

See full description

Eligible Conditions

  • Inflammation
  • Cardiovascular Risk
  • Chronic Kidney Disease (CKD)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Inflammation

Study Objectives

This trial is evaluating whether Ziltivekimab will improve 4 primary outcomes and 43 secondary outcomes in patients with Inflammation. Measurement will happen over the course of From randomisation (month 0) to end-of-study (up to 48 months)..

Year 2
Change in high-sensitivity C-reactive protein (hs-CRP)
Year 2
Change in N-terminal-pro-brain natriuretic peptide ( NT-pro-BNP)
Change in Short Form 36 (SF-36) Physical Component Score (PCS)
Change in UACR (urinary albumin-to-creatinine ratio )
Change in eGFR (CKD-EPI))
Change in eGFR (estimated glomerular filtration rate) (chronic kidney disease - epidemiology collaboration (CKD-EPI))
Change in left ventricular ejection fraction (LVEF)
Year 2
Change in Urinary Abumin-to-Ceatinine ratio (UACR).
Month 48
Number of hospitalisations for heart failure or urgent heart failure visit.
Time to first occ. of composite Chronic Kidney Disease (CKD) endpoint consisting of onset of persistent at least 40% reduction in estimated glomerular filtration rate (eGFR) CKD-Epidemiology Collaboration (CKD-EPI) compared with baseline, kidney failure
Time to first occurrence of 3-point MACE, a composite endpoint consisting of: CV death, non-fatal MI, non-fatal stroke and hospitalisation for unstable angina pectoris requiring urgent coronary revascularisation
Time to first occurrence of 3-point MACE, a composite endpoint consisting of: non-fatal myocardial infarction(MI) ( Based on EAC-confirmed events; including undetermined cause of death; acute MI only)
Time to first occurrence of 3-point MACE, a composite endpoint consisting of: non-fatal stroke (Based on EAC-confirmed events; including ischaemic, haemorrhagic and undetermined stroke)
Time to first occurrence of 3-point Major Adverse Cardiovascular Event (MACE), a composite endpoint consisting of: Cardiovascular (CV) death, non-fatal Myocardial Infarction (MI) and non-fatal stroke.
Time to first occurrence of 3-point major adverse cardiovascular event (MACE), a composite endpoint consisting of: Cardiovascular (CV ) death (Based on EAC-confirmed events; including undetermined cause of death)
Time to occurrence of all-cause mortality.
Month 48
Number of hospitalisations for heart failure (Based on EAC-confirmed events) or urgent heart failure visit (Based on EAC-confirmed events)
Time to first occurrence of a composite CKD endpoint consisting of kidney failure defined as:death from kidney failure
Time to first occurrence of a composite CKD endpoint consisting of: initiation of chronic kidney replacement therapy (maintenance dialysis or kidney transplantation (Based on EAC-confirmed events)
Time to first occurrence of a composite CKD endpoint consisting of:kidney failure defined as onset of persistente eGFR below 15 mL/min/1.73 m^2 (CKD-EPI)
Time to first occurrence of a composite CKD endpoint consisting of:onset of persistent greater than or equal to 40% reduction in eGFR (CKD-EPI) compared with baseline
Time to occurrence of all-cause mortality (Based on EAC-confirmed events)
Month 48
Time to first occurrence of expanded MACE, a composite endpoint consisting of: CV death (Based on EAC-confirmed events; including undetermined cause of death
Time to first occurrence of expanded MACE, a composite endpoint consisting of: hospitalisation for unstable angina pectoris requiring urgent coronary revascularisation (Based on EAC-confirmed events)
Time to first occurrence of expanded MACE, a composite endpoint consisting of: non-fatal MI (Based on EAC-confirmed events; acute MI only)
Time to first occurrence of expanded MACE, a composite endpoint consisting of: non-fatal stroke (Based on EAC-confirmed events; including ischaemic, haemorrhagic and undetermined stroke)
Month 48
Number of hospitalisations with infection as primary cause (Based on EAC-confirmed events) or death due to infection (Based on EAC-confirmed events)
Time to first occurrence of MIs (acute MI only) (fatal and non-fatal) (Based on EAC-confirmed events)
Time to first occurrence of a composite MACE endpoint consisting of:all-cause mortality (Based on EAC-confirmed events)
Time to first occurrence of a composite MACE endpoint consisting of:non-fatal MI (Based on EAC-confirmed events; acute MI only)
Time to first occurrence of a composite MACE endpoint consisting of:non-fatal stroke (Based on EAC-confirmed events,including ischaemic, haemorrhagic and undetermined stroke)
Time to first occurrence of an expanded composite kidney endpoint consisting of:CV death (Based on EAC-confirmed events; including undetermined cause of death)
Time to first occurrence of an expanded composite kidney endpoint consisting of:kidney failure defined as onset of persistent eGFR below 15 mL/min/1.73 m^2 (CKD-EPI)
Time to first occurrence of an expanded composite kidney endpoint consisting of:kidney failure defined as:death from kidney failure
Time to first occurrence of an expanded composite kidney endpoint consisting of:kidney failure defined as:initiation of chronic kidney replacement therapy (maintenance dialysis or kidney transplantation) (Based on EAC-confirmed events)
Time to first occurrence of an expanded composite kidney endpoint consisting of:onset of persistent greater than or equal to 40% reduction in eGFR (CKD-EPI) compared with baseline
Time to first occurrence of each of the individual components (Based on EAC-confirmed events) of the expanded MACE endpoint and the kidney composite endpoint
Time to first occurrence of stroke (including ischaemic, haemorrhagic and undetermined stroke) (fatal and non-fatal)(Based on EAC-confirmed events)
Month 48
Annual rate of change in eGFR (CKD-EPI) (total eGFR slope)
Number of events of atrial fibrillation
Number of hospitalisations with infection as primary cause or death due to infection.
Time to first occurrence of MI (fatal and non-fatal).
Time to first occurrence of a composite MACE endpoint consisting of: all-cause mortality, non-fatal MI and non-fatal stroke.
Time to first occurrence of an expanded composite kidney endpoint consisting of: CV death, onset of persistent at least 40% reduction in eGFR (CKD-EPI) compared with baseline, kidney failure.
Time to first occurrence of coronary revascularisation
Time to first occurrence of each of the individual components of the expanded MACE endpoint and the kidney composite endpoint.
Time to first occurrence of stroke (fatal and non-fatal).

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Inflammation

Trial Design

2 Treatment Groups

ziltivekimab 15 mg
1 of 2
Placebo (ziltivekimab)
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 6200 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ziltivekimab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

ziltivekimab 15 mg
Drug
Participants will receive ziltivekimab 15 mg for up to 4 years.
Placebo (ziltivekimab)
Drug
Participants will receive placebo (ziltivekimab) for up to 4 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ziltivekimab
2019
Completed Phase 2
~300

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from randomisation (month 0) to end-of-study (up to 48 months)(maximum treatment duration is dependent on event rates and is estimated to be approximately 48 months including a 3-month follow-up period)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from randomisation (month 0) to end-of-study (up to 48 months)(maximum treatment duration is dependent on event rates and is estimated to be approximately 48 months including a 3-month follow-up period) for reporting.

Closest Location

Novo Nordisk Investigational Site - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Estimated glomerular filtration rate (eGFR) 15 and below 60 mL/min/1.73 m^2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation)
hs-CRP > or = 2 mg/L at screening (visit 1). show original
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).

Patient Q&A Section

Can cardiovascular diseases be cured?

"If patients take an effective medication for as long as possible, their risk of cardiovascular diseases can be reduced. Therefore, it is important to initiate a drug treatment as early as possible, avoiding complications and allowing patients to maintain or even increase their activities." - Anonymous Online Contributor

Unverified Answer

What is cardiovascular diseases?

"Cardiovascular diseases (CVD) consist of a group of disorders and diseases that share a number of causal factors and risk factors. Although CVD is a significant cause of morbidity and mortality, its primary prevention is not feasible with current medical technology in the 21st century and current medical and socioeconomic factors. CVD is also costly to the society which is due to increased healthcare expenditure, disability, and fatalities. CVD mortality in South Asia is among the highest. Epidemiology, prevention, and research studies as well as clinical and public health practices are important to improve survival from CVD." - Anonymous Online Contributor

Unverified Answer

How many people get cardiovascular diseases a year in the United States?

"Based on the number of cardiovascular diseases (as represented by hospitalizations) documented in the U.S. database (n = 5,478,638), the average CVD patient experiences 1.8 hospitalizations per year. This number is likely substantially underestimated. The fact that there are 3.5 million hospitalizations for CVDs a year underscores the importance of timely recognition and management of CVDs for the prevention of its morbidity, mortality and cost to the patient." - Anonymous Online Contributor

Unverified Answer

What are the signs of cardiovascular diseases?

"Many of those with signs of cardiovascular disease use them as a first aid, but the signs are not generally recognised as such, which could lead to delays in seeking appropriate care. Those who have unexplained recurrent respiratory infection are more likely to be under screened by medical practitioners. The majority of patients with cardiovascular risk factors are under-invited for specialist consultations for cardiac health. We suggest screening for cardiovascular risk factors, including those with chest pain, those aged >50 years or those living alone. It may also be useful for health professionals to examine signs of cardiovascular disease in people with unexplained fatigue." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cardiovascular diseases?

"The most common treatments for some typical cardiovascular diseases and indications of its usage include: Beta blockers, calcium channel blocker, ACE(I/E inhibitors), thiazide, statins, aspirin, angiotensin II receptor blocker, and anticoagulant." - Anonymous Online Contributor

Unverified Answer

What causes cardiovascular diseases?

"Coronary artery disease (CAD) begins with exposure to risk factors such as smoking, diabetes mellitus and hypertension. The risk for progression to symptomatic disease increases with the number of risk factors present. The risk of serious cardiovascular diseases increases 10-fold in patients with three or more risk factors. For most of these patients atherosclerosis is the predominant underlying cause of CAD. Thus, the disease process is highly amenable to medical treatment designed to reduce the effects of coronary atherosclerosis. Therefore, all patients with CAD need regular medical surveillance to detect progress of the disease, and to initiate preventive measures." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cardiovascular diseases?

"The authors believe that patients' general interest and self-perception are not reliable enough to make people decide on whether or not to take part in a clinical trial. Considering only the patients' perspective is likely to miss those patients who would probably benefit and is likely to lead to suboptimal treatment." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of cardiovascular diseases?

"The majority of CVDs are highly preventable by lifestyle changes, health literacy, and access to the health care system, while the primary causes are high levels of blood pressure, unhealthy diet and tobacco use. The United Kingdom's Health and Social Care Reform Policy has led to changes in lifestyle habits." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving ziltivekimab?

"The preliminary results of the present study may serve as a useful guide to design and carry out further clinical study on ziltivekimab after completion of the Phase III MONITOR trial in March 2014." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cardiovascular diseases?

"Data from a recent study of the present review give an overview of the most recent advances of medical treatments for cardiovascular diseases. We show how innovative and high-risk therapies have been introduced in the past 20 years, and we indicate the potential of future advances." - Anonymous Online Contributor

Unverified Answer

Does cardiovascular diseases run in families?

"The CVD-related gene variants identified in the present population are mainly those that are related to coronary and valvular heart disease, in particular of ascending aortic aneurysms, and so CVRF mutations are associated with the development of cardiovascular diseases." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating cardiovascular diseases?

"There have been many improvements for treating coronary artery disease but we are still far from a complete understanding. Nevertheless, there were many advances in the use of statins and fibrates to treat heart disease and also for use in cancer treatment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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