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Ziltivekimab for Heart Failure (HERMES Trial)

Phase 3
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Diagnosis of heart failure (New York Heart Association [classification] [NYHA] Class II-IV).
Hospitalisation or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous loop diuretic treatment, within the last 9 months prior to screening (visit 1) in combination with NT-proBNP greater than equal to 200 pg/mL at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NT-proBNP must be greater than equal to 600 pg/mL.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomisation (month 0) to end of study (up to 48 months)
Awards & highlights

HERMES Trial Summary

This trial will test if ziltivekimab can treat heart failure & inflammation. It will last 4 yrs, with up to 20 clinic visits & use of a study app.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
While the potential side effects are not listed here, common ones associated with medications like Ziltivekimab may include injection site reactions, nausea, headaches, possible increased risk of infections due to immune system alteration.

HERMES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with heart failure and it affects my daily activities.
Select...
I was hospitalized for heart failure and needed IV treatment in the last 9 months, and my NT-proBNP levels are high.
Select...
My heart pumps well, with an LVEF over 40% in the last year.
Select...
My hs-CRP level is 2 mg/L or higher, indicating inflammation related to heart disease.
Select...
I have been diagnosed with heart failure and it affects my daily activities.

HERMES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomisation (month 0) to end of study (up to 48 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomisation (month 0) to end of study (up to 48 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to First Occurrence of a Composite Heart Failure Endpoint Consisting of: Cardiovascular (CV) Death, Heart Failure (HF) Hospitalisation or Urgent HF Visit
Secondary outcome measures
Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope)
Change in Estimated Glomerular Filtration Rate (eGFR) (Chronic Kidney Disease - Epidemiology Collaboration [CKD-EPI])
Change in High-sensitivity C-reactive Protein (hs-CRP)
+15 more

Side effects data

From 2020 Phase 2 trial • 264 Patients • NCT03926117
9%
Hypertension
6%
Dizziness
5%
Nasopharyngitis
5%
Urinary tract infection
5%
Cough
3%
Arthralgia
2%
Hemiparesis
2%
Bronchitis viral
2%
Oesophageal cancer metastatic
2%
Hypoglycaemia
2%
Acute myocardial infarction
2%
Cerebrovascular accident
2%
Transient ischaemic attack
2%
Peritonitis
2%
Cardiac failure congestive
2%
Oedema peripheral
2%
Diarrhoea
2%
Coronary artery disease
2%
Diabetic ketoacidosis
2%
Hypertensive urgency
2%
Nephropathy
2%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Ziltivekimab 15 mg
Ziltivekimab 7.5 mg
Ziltivekimab 30 mg

HERMES Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ziltivekimab 15 mgExperimental Treatment1 Intervention
Participants will receive ziltivekimab 15 milligrams (mg) 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ziltivekimab
2019
Completed Phase 2
~300

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,409,468 Total Patients Enrolled
8 Trials studying Heart Failure
24,443 Patients Enrolled for Heart Failure
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
106 Previous Clinical Trials
134,226 Total Patients Enrolled
1 Trials studying Heart Failure
21,504 Patients Enrolled for Heart Failure

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05636176 — Phase 3
Heart Failure Research Study Groups: Placebo, Ziltivekimab 15 mg
Heart Failure Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05636176 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05636176 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Ziltivekimab 15 mg for use?

"We rate the safety of Ziltivekimab 15 mg as a 3, based on clinical data demonstrating efficacy and multiple iterations confirming its safety."

Answered by AI

What geographical areas host this clinical trial?

"At the moment, this medical study is taking on patients through 48 different sites. These include Richmond, Saint Augustine and Sherman as well as many other places. It would be wise to pick a suitable location closeby in order to limit any travelling needs for participants if they choose to join the trial."

Answered by AI

Are fresh participants being accepted for this clinical exploration?

"According to the records on clinicaltrials.gov, this particular experiment is not currently seeking any participants. This research was initially posted in May 8th 2023 and last modified December 6th 2022. Nevertheless, 1053 other investigations are actively recruiting patients at this moment."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Novo Nordisk Investigational Site
Tennova Healthcare-Turkey Creek Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

Cause I have heart problems.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
Recent research and studies
clinicaltrials.govStudy
A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation
2023. "A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05636176.
All > Toronto > Meridian
~3733 spots leftby Jul 2027
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