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A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT06200207•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 centimeter (cm)
•3. LA length greater than or equal to 5.0 cm
•4. LA area greater than or equal to 20 square centimeter (cm\^2)
+8 more criteria

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)
+2 more criteria

Locations (239)

Advanced Cardiovascular, LLC

Alexander City, Alabama, United States

Eastern Shore Rsrch Inst, LLC

Fairhope, Alabama, United States

Cardiology & Medicine Clinic

Little Rock, Arkansas, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

UCI Health

Orange, California, United States

South California Heart Spc

Pasadena, California, United States

Clearwater Cardiovascular Consultants

Largo, Florida, United States

Clearwater Cardiovascular Consultants

Largo, Florida, United States

Ocala Cardiovascular Research

Ocala, Florida, United States

Key Dates

Start Date

April 1, 2024

Primary Completion Date

October 1, 2026

Completion Date

January 8, 2027

Last Updated

March 11, 2026

Enrollment

680

ESTIMATED participants

Conditions

Heart FailureSystemic Inflammation

Interventions

Ziltivekimab

DRUG

Placebo

DRUG

Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178 clinicaltrials@novonordisk.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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