What is ziltivekimab studying for heart failure and inflammation?

Ziltivekimab is being studied to see how it affects symptoms and physical function in people with heart failure and systemic inflammation. This trial compares ziltivekimab to a placebo to better understand its impact on heart health. The research is sponsored by Novo Nordisk A/S and aims to contribute to treatment options for this condition.

Who may be eligible for this heart failure clinical trial?

Adults aged 18 years or older with heart failure classified as New York Heart Association Class II or III and elevated inflammation markers may be eligible. Both males and females can participate, provided they meet heart function and symptom criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this heart failure clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect support during the trial but should plan for their own travel arrangements.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06200207

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

Led by Novo Nordisk A/S · Updated on 2026-04-07

680

Participants Needed

240

Research Sites

14 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying whether ziltivekimab can help people living with heart failure and inflammation. The trial focuses on participants with heart failure who have mild to preserved heart function and systemic inflammation. This phase 3 study compares ziltivekimab, a new medicine not yet approved, to an inactive placebo to understand its effects on heart failure symptoms and physical function. Participants will receive either ziltivekimab or a matching placebo administered as a subcutaneous injection once a month for 12 months. Both groups will continue their standard heart failure care alongside the study treatment. The treatment assignment is randomized, meaning participants have an equal chance of receiving the active medicine or placebo, and the study uses a quadruple masking method to keep participants and researchers unaware of the treatment given. During the study, participants will be monitored for changes in heart failure symptoms using tools like the Kansas City Cardiomyopathy Questionnaire and a 6-minute walk test. Researchers will also assess inflammation markers, heart function measures, and quality of life at regular intervals over the 12 months. The study aims to observe the effects of ziltivekimab compared to placebo over this period, with safety and symptom improvement carefully tracked.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 mg/L at screening
N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than or equal to 225 pg/mL (375 pg/mL if atrial fibrillation/flutter) at screening
Diagnosis of heart failure with New York Heart Association (NYHA) Class II-III
Left ventricular ejection fraction (LVEF) greater than 40% documented by echocardiography within 12 months prior to or at screening
Structural or functional heart disease confirmed by echocardiography within 12 months prior to or at screening showing specified criteria such as left atrial enlargement or increased wall thickness
No heart failure hospitalizations or urgent visits between screening and randomisation
Ability to perform a 6-minute walk test with a minimum distance of 100 meters at screening
Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score less than 80 at screening

You will not qualify if you...

Myocardial infarction, stroke, unstable angina, transient ischemic attack, or heart failure hospitalization within 30 days prior to screening
Systolic blood pressure greater than or equal to 180 mmHg at screening, or 160-179 mmHg if receiving three or more antihypertensive drugs
Heart rate above 110 or below 40 beats per minute at screening ECG
Planned coronary, carotid, or peripheral artery revascularization during screening
Planned cardiac device implantation or atrial flutter/atrial fibrillation ablation during screening
Major cardiac, non-cardiac, or endoscopic surgery within 60 days prior to randomisation or planned at randomisation
Heart failure due to specific cardiomyopathies or active myocarditis
Severe pulmonary diseases such as primary pulmonary hypertension or COPD
Other conditions that may explain heart failure symptoms such as anemia or hypothyroidism
Clinical evidence or suspicion of active infection at screening as judged by investigator

Research Team

Novo Nordisk

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