Ziltivekimab for Heart Failure
(HERMES Trial)
Recruiting in Palo Alto (17 mi)
+1430 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Novo Nordisk A/S
Disqualifiers: Recent MI, Stroke, Unstable angina, others
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is testing ziltivekimab to see if it can help people with heart failure and inflammation by reducing inflammation and improving heart function.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop your current medications. However, it is common for clinical trials to have specific guidelines about medication use, so it's best to discuss this with the trial coordinators.
What data supports the idea that the drug Ziltivekimab for Heart Failure is an effective treatment?
The available research does not provide specific data supporting the effectiveness of Ziltivekimab for treating heart failure. Instead, it mentions a study where Ziltivekimab was used to reduce inflammation in patients with chronic kidney disease, not heart failure. Other studies focus on different treatments for heart failure, like Anakinra and Celacade, but not Ziltivekimab. Therefore, there is no direct evidence from the provided information that Ziltivekimab is effective for heart failure.12345
What safety data is available for Ziltivekimab in heart failure treatment?
The provided research does not contain specific safety data for Ziltivekimab or its other names (COR-001, MEDI-5117, etc.) in the context of heart failure treatment. The articles focus on other treatments and drugs for heart failure, such as omecamtiv mecarbil, anakinra, and vericiguat, but do not mention Ziltivekimab or its associated names.16789
Research Team
CT
Clinical Transparency (dept. 2834)
Principal Investigator
Novo Nordisk A/S
Eligibility Criteria
This trial is for people with heart failure and inflammation. They must have a certain level of left atrial volume, high levels of C-reactive protein, and meet specific criteria related to heart function documented by echocardiography or hospital visits. It's not for those who've had recent major cardiac events/surgery, planned procedures, specific cardiomyopathies, extremely high blood pressure or abnormal heart rates.Inclusion Criteria
I have been diagnosed with heart failure and it affects my daily activities.
Your N-terminal-pro-brain natriuretic peptide (NT-proBNP) level needs to be below a certain number if you don't have atrial fibrillation/flutter, and a higher number if you do have atrial fibrillation/flutter.
My heart pumps well, with an LVEF over 40% in the last year.
See 9 more
Exclusion Criteria
Your heart rate is either too fast (above 110 beats per minute) or too slow (below 40 beats per minute) when checked with a special heart test.
I am scheduled for a procedure to improve blood flow to my heart or other areas during the screening period.
My blood pressure is 180 mmHg or higher, or it's 160-179 mmHg and I'm on 3 or more blood pressure medications.
See 4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive once-monthly injections of either ziltivekimab or placebo for up to 4 years
48 months
Up to 20 clinic visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Placebo (Other)
- Ziltivekimab (Monoclonal Antibodies)
Trial OverviewThe study tests if Ziltivekimab can treat heart failure with inflammation compared to a placebo. Participants will be randomly assigned to receive either the drug or placebo and monitored up to 4 years through clinic visits and an app that tracks injections and questionnaires.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ZiltivekimabExperimental Treatment1 Intervention
Participants will receive ziltivekimab subcutaneous (s.c.) injection once-monthly and added standard of care for up to 4 years.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive ziltivekimab placebo s.c. injection once-monthly and added standard of care for up to 4 years.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Baptist Health HardinElizabethtown, KY
Novo Nordisk Investigational SiteSan Diego, CA
Novo Nordisk Investigational SiteGreensboro, NC
Novo Nordisk Investigational SiteCharlottesville, VA
More Trial Locations
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Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Trials
1578
Patients Recruited
3,813,000+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Rationale and design of interleukin-1 blockade in recently decompensated heart failure (REDHART2): a randomized, double blind, placebo controlled, single center, phase 2 study.Van Tassell, B., Mihalick, V., Thomas, G., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Broad modulation of tissue responses (immune activation) by celacade may favorably influence pathologic processes associated with heart failure progression.Torre-Amione, G., Sestier, F., Radovancevic, B., et al.[2007]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Effect of Ziltivekimab on Determinants of Hemoglobin in Patients with CKD Stage 3-5: An Analysis of a Randomized Trial (RESCUE).Pergola, PE., Davidson, M., Jensen, C., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Interleukin-1 Blockade in Recently Decompensated Systolic Heart Failure: Results From REDHART (Recently Decompensated Heart Failure Anakinra Response Trial).Van Tassell, BW., Canada, J., Carbone, S., et al.[2018]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials: JACC Review Topic of the Week.Fiuzat, M., Hamo, CE., Butler, J., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Safety and efficacy of omecamtiv mecarbil for heart failure: A systematic review and meta-analysis.Alqatati, F., Elbahnasawy, M., Bugazia, S., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Vericiguat and Health-Related Quality of Life in Patients With Heart Failure With Reduced Ejection Fraction: Insights From the VICTORIA Trial.Butler, J., Stebbins, A., Melenovský, V., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
New perspectives and future directions in the treatment of heart failure.Pellicori, P., Khan, MJI., Graham, FJ., et al.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Recently Approved and Under Investigation Drugs for Treating Patients with Heart Failure.Castro-Torres, Y., Katholi, RE.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects.Bush, J., Kawakami, K., Muniz, R.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Pharmacokinetic Similarity of ABP 654, an Ustekinumab Biosimilar Candidate: Results from a Randomized, Double-blind Study in Healthy Subjects.Chow, V., Mytych, DT., Das, S., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Zarxio (Filgrastim-sndz): The First Biosimilar Approved by the FDA.Awad, M., Singh, P., Hilas, O.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The "final" 5-year follow-up from the ENDEAVOR IV trial comparing a zotarolimus-eluting stent with a paclitaxel-eluting stent.Kirtane, AJ., Leon, MB., Ball, MW., et al.[2015]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Pharmacokinetic and pharmacodynamic bioequivalence of biosimilar MYL-1601D with US and European insulin aspart in healthy volunteers: A randomized, double-blind, crossover, euglycaemic glucose clamp study.Hövelmann, U., Raiter, Y., Chullikana, A., et al.[2022]
References
Rationale and design of interleukin-1 blockade in recently decompensated heart failure (REDHART2): a randomized, double blind, placebo controlled, single center, phase 2 study. [2023]
Broad modulation of tissue responses (immune activation) by celacade may favorably influence pathologic processes associated with heart failure progression. [2007]
Effect of Ziltivekimab on Determinants of Hemoglobin in Patients with CKD Stage 3-5: An Analysis of a Randomized Trial (RESCUE). [2023]
Interleukin-1 Blockade in Recently Decompensated Systolic Heart Failure: Results From REDHART (Recently Decompensated Heart Failure Anakinra Response Trial). [2018]
Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials: JACC Review Topic of the Week. [2023]
Safety and efficacy of omecamtiv mecarbil for heart failure: A systematic review and meta-analysis. [2022]
Vericiguat and Health-Related Quality of Life in Patients With Heart Failure With Reduced Ejection Fraction: Insights From the VICTORIA Trial. [2022]
New perspectives and future directions in the treatment of heart failure. [2021]
Recently Approved and Under Investigation Drugs for Treating Patients with Heart Failure. [2021]
A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects. [2020]
Pharmacokinetic Similarity of ABP 654, an Ustekinumab Biosimilar Candidate: Results from a Randomized, Double-blind Study in Healthy Subjects. [2023]
Zarxio (Filgrastim-sndz): The First Biosimilar Approved by the FDA. [2020]
The "final" 5-year follow-up from the ENDEAVOR IV trial comparing a zotarolimus-eluting stent with a paclitaxel-eluting stent. [2015]
Pharmacokinetic and pharmacodynamic bioequivalence of biosimilar MYL-1601D with US and European insulin aspart in healthy volunteers: A randomized, double-blind, crossover, euglycaemic glucose clamp study. [2022]