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Study stopped earlyPhase3

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

Sponsor: Novo Nordisk A/S

NCT ID: NCT05636176

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Ziltivekimab (drug), Placebo (drug)
How long the study runs
Study runs about 40 months (dates as stated)
About the drug or intervention
Ziltivekimab — drug: Ziltivekimab subcutaneous (s.c.) injection in a pre-filled syringe or a pen-injector once-monthly for up to 4 years. · Placebo — drug: Ziltivekimab placebo s.c.
Patient visit burden
"Participants will have up to 20 clinic visits." (as stated by sponsor)
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
4,874
Started
2023-05-08
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure
  • • Phase3 - 4,874 participants
  • • This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with heart failure

Where?

  • • Bournemouth - Royal Bournemouth Hospital
  • • Basildon - Basildon University Hospital
  • • Airdrie - University Hospital Monklands - Cardiology Research
  • • Tooting - St George's Hospital - Cardiology
  • • +18 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

Heart Failure

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ intravenous loop diuretic treatment, within the last 9 months

What the study is looking for

  • ✓Serum high-sensitivity C-reactive protein (hs-CRP) greater than equal to 2 milligrams per liter (mg/L) at screening...
  • ✓At least one of the following:
  • ✓Diagnosis of heart failure (New York Heart Association \[classification\] \[NYHA\] Class II-IV).
  • ✓Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or...
  • ✓Left atrial (LA) volume index greater than 34 milliliters per meter square (mL/m\^2).

Who cannot take part

  • ✗Medical conditions - cardiovascular
  • ✗Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure...
  • ✗Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1). (Note:...
  • ✗Planned heart device or atrial flutter/atrial fibrillation ablation procedure known during the screening period...
  • ✗Primary lung hypertension, chronic lung embolism, severe lung disease including COPD.
See the full criteria
Inclusion Criteria: * Serum high-sensitivity C-reactive protein (hs-CRP) greater than equal to 2 milligrams per liter (mg/L) at screening (visit 1) Disease specific - cardiovascular * At least one of the following: 1. N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than equal to 300 picograms per milliliter (pg/mL) at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NTproBNP must be greater than equal to 600 pg/mL. Note that the screening electrocardiogram (ECG) must be obtained the same day as sampling for NT-proBNP. 2. Hospitalisation or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous loop diuretic treatment, within the last 9 months prior to screening (visit 1) in combination with NT-proBNP greater than equal to 200 pg/mL at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NT-proBNP must be greater than equal to 600 pg/mL. * Diagnosis of heart failure (New York Heart Association \[classification\] \[NYHA\] Class II-IV). * Left ventricular ejection fraction (LVEF) greater than 40 percentage (%) documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (e.g., myocardial infarction \[MI\] or heart failure \[HF\] hospitalisation). * Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or at screening (visit 1) showing at least one of the following: * Left atrial (LA) volume index greater than 34 milliliters per meter square (mL/m\^2). * LA diameter greater than equal to 3.8 centimeters (cm). * LA length greater than equal to 5.0 cm. * LA area greater than equal to 20 cm square. * LA volume greater than equal to 55 milliliters (mL). * Intraventricular septal thickness greater than equal to 1.1 cm. * Posterior wall thickness greater than equal to 1.1 cm. * Left ventricular (LV) mass index greater than equal to 115 grams per meter square (g⁄m\^2 ) in men or greater than equal to 95 g⁄m\^2 in women. * E/e' (mean septal and lateral) greater than equal to 10. * e' (mean septal and lateral) less than 9 centimeter per second (cm/s). * No heart failure hospitalisations or urgent heart failure visits between screening (visit 1) and randomisation (visit 2). Exclusion Criteria: Medical conditions - cardiovascular * Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation, within 30 days prior to screening (visit 1). * Systolic blood pressure greater than equal to 180 millimeters of mercury (mmHg) at screening (visit 1). If the systolic blood pressure is 160-179 mmHg, the patient should be receiving greater than equal to 3 antihypertensive drugs. (Note: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator). * Heart rate above 110 or below 40 beats per minute as evaluated on the electrocardiogram (ECG) performed at screening (visit 1) (Note: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator). * Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1). (Note: Planned coronary angiogram is not exclusionary). * Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1). * 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). * Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease. * Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD. * Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism). Medical conditions - infections/immunosuppression \- Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.

Where Is This Study? (22 UK sites)

Royal Bournemouth Hospital

Bournemouth BH7 7DW, United Kingdom

Hospital R&D contact (matched)

Research Development & Support

clinicalresearch@bournemouth.ac.uk01202 961200

Basildon University Hospital

Basildon SS16 5NL, United Kingdom

University Hospital Monklands - Cardiology Research

Airdrie ML6 0JS, United Kingdom

St George's Hospital - Cardiology

Tooting SW17 0RE, United Kingdom

Hospital R&D contact (matched)

Mr Subhir Bedi

researchgovernance@sgul.ac.uk020 8725 4986

St George's Hospital

Tooting SW17 0RE, United Kingdom

Hospital R&D contact (matched)

Mr Subhir Bedi

researchgovernance@sgul.ac.uk020 8725 4986

University Hospital Hairmyres - Cardiology

East Kilbride G75 8RG, United Kingdom

St. Richard's Hospital_Cardiology

Chichester PO19 6SE, United Kingdom

St. Richards Hospital

Chichester PO19 6SE, United Kingdom

Aberdeen Royal Infirmary

Aberdeen AB25 2ZN, United Kingdom

Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

Southmead Hospital

Bristol BS10 5NB, United Kingdom

Hospital R&D contact (matched)

Helen Lewis-White

Research@nbt.nhs.uk0117 41 49330

Craigavon Area Hospital - Cardiovascular Research Unit

Craigavon BT63 5QQ, United Kingdom

Royal Bournemouth Hospital

Dorest BH7 7DW, United Kingdom

Hospital R&D contact (matched)

Research Development & Support

clinicalresearch@bournemouth.ac.uk01202 961200

Royal Devon and Exeter Hospital

Exeter EX2 5DW, United Kingdom

Hospital R&D contact (matched)

Samantha Smart

rduh.research-eastern@nhs.net01392 406075

Royal Devon University Healthcare NHS Foundation Trust

Exeter EX2 5DW, United Kingdom

Hospital R&D contact (matched)

Samantha Smart

rduh.research-eastern@nhs.net01392 406075

Glasgow Royal Infirmary

Glasgow G31 2ER, United Kingdom

Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

Wycombe General Hospital

High Wycombe HP11 2TT, United Kingdom

Aintree University Hospital

Liverpool L9 7AL, United Kingdom

Hospital R&D contact (matched)

Michelle Mossa

research.development@aintree.nhs.uk0151 529 5870

Manchester Royal Infirmary - Manchester Heart Centre

Manchester M13 9WL, United Kingdom

Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

North Tyneside General Hospital

North Shields NE29 8NH, United Kingdom

Hospital R&D contact (matched)

Research and Development

researchanddevelopment@nhct.nhs.uk0191 2934087

The Royal Oldham Hospital_Cardiology Outpatients Dept.

Oldham OL1 2JH, United Kingdom

John Radcliffe Hospital

Oxford OX3 9DU, United Kingdom

University of North Tees Hospital

Stockton-on-Tees TS19 8PE, United Kingdom

Hospital R&D contact (matched)

Research and Development

nth-tr.ntandh.researchdevelopment@nhs.net01642 624090
Data sourced from ClinicalTrials.gov · Last verified: 2026-09