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Clinical Trials List

Protocol NumberEX6018-4915
Active

2023-05-08 - 2027-07-02

Phase III

Not yet recruiting5

ICD-10I50.20

Unspecified systolic (congestive) heart failure

ICD-10I50.21

Acute systolic (congestive) heart failure

ICD-10I50.22

Chronic systolic (congestive) heart failure

ICD-10I50.23

Acute on chronic systolic (congestive) heart failure

ICD-10I50.30

Unspecified diastolic (congestive) heart failure

ICD-10I50.31

Acute diastolic (congestive) heart failure

ICD-10I50.32

Chronic diastolic (congestive) heart failure

ICD-10I50.33

Acute on chronic diastolic (congestive) heart failure

ICD-10I50.40

Unspecified combined systolic (congestive) and diastolic (congestive) heart failure

ICD-10I50.41

Acute combined systolic (congestive) and diastolic (congestive) heart failure

ICD-10I50.42

Chronic combined systolic (congestive) and diastolic (congestive) heart failure

ICD-10I50.43

Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure

ICD-10I50.9

Heart failure, unspecified

ICD-9428.0

Congestive heart failure

HERMES: Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation.

  • Trial Applicant

    NOVO NORDISK PHARMA (TAIWAN) LTD.

  • Sponsor

    Novo Nordisk A/S

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Shih-Hsien Sung Division of Cardiovascular Diseases
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Pao-Hsien Chu Division of Cardiovascular Diseases
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator WEI-WEN LIN Division of Cardiovascular Diseases
Taichung Veterans General Hospital

Co-Principal Investigator

  • 王奇彥 Division of Cardiovascular Diseases
  • 鄭諭聰 Division of Cardiovascular Diseases
  • 羅勛中 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Tsung-Hsien Lin Division of Cardiovascular Diseases
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chun-Yao Huang
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

heart failure

Objectives

To demonstrate the superiority of ziltivekimab 15 mg s.c. once-monthly versus placebo, both added to standard of care, in reducing the risk of CV death and HF events in participants with HFmrEF or HFpEF and systemic inflammation.

Test Drug

injection

Active Ingredient

Ziltivekimab B
Ziltivekimab C

Dosage Form

230
230

Dosage

15 mg

Endpoints

Time to first occurrence of a
composite HF endpoint consisting of:
 CV death
 HF hospitalisation or urgent
HF visit

Inclution Criteria

 Serum hs-CRP 2 mg/L at screening (visit 1)
Disease specific - cardiovascular
 At least one of the followinga:
a. NT-proBNP ≥ 300 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 ≥600 pg/mL. Note that the screening ECG must be obtained the
same day as sampling for NT-proBNP.
b. 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 ≥ 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 ≥600 pg/mL.
 Diagnosis of heart failure (NYHA Class II-IV).
 LVEF > 40% 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 (e.g., MI or 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:
 LA volume index > 34 mL/m2.
 LA diameter ≥ 3.8 cm.
 LA length ≥ 5.0 cm.
 LA area ≥ 20 cm2.
 LA volume ≥ 55 mL.
 Intraventricular septal thickness ≥1.1 cm.
 Posterior wall thickness ≥1.1 cm.
 LV mass index ≥115 g⁄m2 in men or ≥ 95 g⁄m2 in women.

Exclusion Criteria

 Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart
failure hospitalisation, within 30 days prior to screening (visit 1).
 Systolic blood pressure ≥180 mmHg at screening (visit 1). If the systolic blood pressure is
160-179 mmHg, the patient should be receiving ≥3 antihypertensive drugs. (Note: Potential
participants may be retested for this criterion within the visit window and without
rescreening, at the discretion of the investigator).
 Heart rate above 110 or below 40 beats per minute as evaluated on the ECG performed at
screening (visit 1) (Note: Potential participants may be retested for this criterion within the
visit window and without rescreening, at the discretion of the investigator).
 Planned coronary, carotid or peripheral artery revascularisation known during the screening
period (visit 1). (Note: Planned coronary angiogram is not exclusionary).
 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 COPD.
 Any other condition judged by the investigator that could account for heart failure
symptoms and signs (e.g., anaemia, hypothyroidism).
Medical conditions – infections/immunosuppression
 Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    4900 participants

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