A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation
Condition(s) studied
Investigational drug(s) / intervention(s)
Ziltivekimab: Zilitivekimab will be administered subcutaneously once-monthly.
Placebo: Placebo matched to ziltivekimab will be administered subcutaneously once-monthly.
Study 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
Primary outcome measure(s)
- Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS) — From randomisation (month 0) to end-of-treatment (month 12)
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.
Trial sites (217)
| Facility | City | Region | Status |
|---|---|---|---|
| Advanced Cardiovascular, LLC | Alexander City | Alabama | |
| Eastern Shore Rsrch Inst, LLC | Fairhope | Alabama | |
| Cardiology & Medicine Clinic | Little Rock | Arkansas | |
| Valley Clinical Trials, Inc. | Northridge | California | |
| UCI Health | Orange | California | |
| South California Heart Spc | Pasadena | California | |
| Clearwater Cardiovascular Consultants | Largo | Florida | |
| Ocala Cardiovascular Research | Ocala | Florida | |
| Ormond Beach Clinical Research | Ormond Beach | Florida | |
| St Johns Ctr Clin Rsch-St. Aug | Saint Augustine | Florida | |
| GA Arrhythmia Cons & Rsch Inst | Macon | Georgia | |
| Velocity Clin Rsrch - Savannah | Savannah | Georgia | |
| Chicago Medical Research LLC | Hazel Crest | Illinois | |
| UofL Health Care Outpatient | Louisville | Kentucky | |
| Maryland Cardiovascular Specialists - Baltimore | Baltimore | Maryland | |
| MD Medical Research | Oxon Hill | Maryland | |
| Cardio and Vascular Assoc-CAVA | Bloomfield Hills | Michigan | |
| Millennium Cardiology | Farmington Hills | Michigan | |
| Kansas City VA Medical Center | Kansas City | Missouri | |
| Washington University | St Louis | Missouri | |
| Renown Regional Medical Center | Reno | Nevada | |
| Long Island Cardiovascular Consultants PC | Lake Success | New York | |
| Mount Sinai Hosp at NYC | New York | New York | |
| Northwell Health Phys Cardio | Riverhead | New York | |
| University Of North Carolina At Chapel Hill | Chapel Hill | North Carolina | |
| AMS Cardiology | Horsham | Pennsylvania | |
| Univ of Pennsylvania Hospital | Philadelphia | Pennsylvania | |
| PharmaTex Research | Amarillo | Texas | |
| University of Texas Southwestern Medical Center | Dallas | Texas | |
| David Turbay, MD, PLLC | El Paso | Texas | |
| Private Practice Leadership LLC. | Katy | Texas | |
| Clinical Advancement Center | San Antonio | Texas | |
| Clinical Advancement Ctr, PLLC | San Antonio | Texas | |
| Sherman Clinical Research | Sherman | Texas | |
| Northwest Heart Center | Tomball | Texas | |
| Sentara Health Research Center | Norfolk | Virginia | |
| Virginia Commonwealth University | Richmond | Virginia | |
| Cardiología Palermo | City of Buenos Aires | Buenos Aires | |
| Centro Médico CIMEL | Lanús Este | Buenos Aires | |
| Instituto de Investigaciones Clinicas Quilmes SRL | Buenos Aires | Argentina |
+ 177 more sites — see the full list on the official registry below.
More Novo Nordisk A/S trials in Poland
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06200207 on ClinicalTrials.gov ↗ ← All trials in Poland