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ACTIVE NOT RECRUITINGPhase3

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

Sponsor: Novo Nordisk A/S

NCT ID: NCT06200207

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 33 months (dates as stated)
About the drug or intervention
Ziltivekimab — drug: Zilitivekimab will be administered subcutaneously once-monthly. · Placebo — drug: Placebo matched to ziltivekimab will be administered subcutaneously once-monthly.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
673
Started
2024-04-01
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure
  • • Phase3 - 673 participants
  • • The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation

Who can take part?

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

Where?

  • • Inverness - Raigmore Hospital
  • • Chichester - St. Richard's Hospital_Cardiology
  • • Birmingham - FutureMeds
  • • Dundee - Ninewells Hospital
  • • +1 more UK sites

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

About This Trial

The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's 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 that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.

Heart FailureSystemic Inflammation

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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

What the study is looking for

  • ✓Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 milligrams per liter (mg/L) at...
  • ✓Disease specific - cardiovascular:
  • ✓N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than or equal to 225 picograms per milliliter (pg/mL)...
  • ✓Diagnosis of heart failure (New York heart association (NYHA) Class II-III)
  • ✓Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or...

Who cannot take part

  • ✗Medical conditions - cardiovascular:
  • ✗Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure...
  • ✗Heart rate above 110 or below 40 beats per minute as evaluated on the Electrocardiogram (ECG) performed at screening...
  • ✗Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1)
  • ✗Planned heart device or atrial flutter/atrial fibrillation ablation procedure known during the screening period...
See the full criteria
Inclusion Criteria: * Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 milligrams per liter (mg/L) at screening (visit 1) * Disease specific - cardiovascular: * N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than or equal to 225 picograms per milliliter (pg/mL) (375 pg/mL for participants with atrial fibrillation/flutter) at screening * Diagnosis of heart failure (New York heart association (NYHA) Class II-III) * Left ventricular ejection fraction (LVEF) greater than 40 percent 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 (example 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: 1. Left atrial (LA) volume index greater than 34 milliliter per square meter (mL/m\^2) 2. LA diameter greater than or equal to 3.8 centimeters (cm) 3. LA length greater than or equal to 5.0 cm 4. LA area greater than or equal to 20 square centimeters (cm\^2) 5. LA volume greater than or equal to 55 milliliters (mL) 6. Intraventricular septal thickness greater than or equal to 1.1 cm 7. Posterior wall thickness greater than or equal to 1.1 cm 8. LV mass index greater than or equal to 115 grams per square meter (g/m\^2) in men or greater than or equal to 95 g/m\^2 in women h) E/e' (mean septal and lateral) greater than or equal to 10 i) e' (mean septal and lateral) less than 9 centimeters per second (cm/s) * No heart failure hospitalisations or urgent heart failure visits between screening and randomisation * Able to perform the 6-minute walk test (6MWT) at screening with a minimum distance of 100 metres * Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score lesser than 80 at screening 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 or 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 or equal to 3 antihypertensive drugs * Heart rate above 110 or below 40 beats per minute as evaluated on the Electrocardiogram (ECG) performed at screening (visit 1) * Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1) * 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 chronic obstructive pulmonary disease (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? (5 UK sites)

Raigmore Hospital

Inverness IV2 3JH, United Kingdom

St. Richard's Hospital_Cardiology

Chichester PO19 6SE, United Kingdom

FutureMeds

Birmingham B21 9RY, United Kingdom

Ninewells Hospital

Dundee DD2 1GZ, United Kingdom

Hospital R&D contact (matched)

Mrs Liz Coote

Liz.Coote@nhs.scot01382 383876

Peterborough City Hospital

Peterborough PE3 9GZ, United Kingdom

Hospital R&D contact (matched)

Hannah Wroe

nwangliaft.rddepartment@nhs.net01733 677919
Data sourced from ClinicalTrials.gov · Last verified: 2026-09