A Phase 3 interventional study of Ziltivekimab and Placebo in Heart Failure and Systemic Inflammation, sponsored by Novo Nordisk A/S. Active, not recruiting at 217 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 673 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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)
Exclusion Criteria:
Participants will receive ziltivekimab administered subcutaneously (s.c.) once-monthly and added to standard of care for 12 months.
Drug: Ziltivekimab
Participants will receive placebo matched to ziltivekimab administered s.c. once-monthly and added to standard of care for 12 months.
Drug: Placebo
Zilitivekimab will be administered subcutaneously once-monthly.
Placebo matched to ziltivekimab will be administered subcutaneously once-monthly.
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS)
Measured as score (score on scale; range; 0-100). The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Time frame: From randomisation (month 0) to end-of-treatment (month 12)
Participant achieving threshold for clinically meaningful within-participant change in KCCQ CSS (yes/no)
Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Time frame: From randomisation (month 0) to end-of-treatment (month 12)
Participant achieving threshold for clinically meaningful within-participant change in 6-minute walk distance (6MWD) (yes/no)
Measured as count of participants.
Time frame: From randomisation (month 0) to end-of-treatment (month 12)
Participants improving 5 points or more in KCCQ-CSS (yes/no)
Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Time frame: From randomisation (month 0) to end-of-treatment (month 12)
Participants improving 10 points or more in KCCQ-CSS (yes/no)
Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Time frame: From randomisation (month 0) to end-of-treatment (month 12)
Change in subscales of KCCQ (total symptom score, physical limitations score, social limitations score, and health-related quality of life)
Measured as score (score on scale; range 0-100). The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Time frame: From randomisation (month 0) to end-of-treatment (month 12)
Change in six-minute walk distance (6MWD)
Measured in meters.
Time frame: From randomisation (month 0) to end-of-treatment (month 12)
Change in high-sensitivity C-reactive protein (hs-CRP)
Measured as ratio to baseline.
Time frame: From randomisation (month 0) to end-of-treatment (month 12)
Participants experiencing improvement in New York heart association (NYHA) Class (yes/no)
Measured as count of participants. The New York Heart Association (NYHA) classification provides a simple way of classifying the extent of heart failure (HF). It classifies patients in one of four categories based on their limitations during physical activity - Class I: Participant with cardiac disease but without resulting limitations of physical activity, Class II: Participants with cardiac disease resulting in slight limitation of physical activity, Class III: Participants with cardiac disease resulting in marked limitation of physical activity, Class IV: Participants with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Time frame: From randomisation (month 0) to end-of-treatment (month 12)
Change in N-terminal-pro-brain natriuretic peptide (NT-proBNP)
Measured as ratio to baseline.
Time frame: From randomisation (month 0) to end-of-treatment (month 12)
Change in eGFR (CKD-EPI)
eGFR (CKD-EPI) is estimated glomerular filtration rate chronic kidney disease - epidemiology collaboration. Measured in milliliter per minute per 1.73 square meter (ml/min/1.73\^2).
Time frame: From randomisation (month 0) to end-of-treatment (month 12)
Showing the first 100 of 217 sites across 16 countries.
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S