Heart Failure
Conditions
Brief summary
This study will look into how CDR132L (a potential new medicine) works on the structure and function of the heart in people living with heart failure. Participants will either get CDR132L or placebo (a medicine which has no effect on the body), which treatment the participants get is decided by chance. The study will last for about 60 weeks.
Interventions
DRUGCDR132L
CDR132L will be administered intravenously once every 4 weeks.
DRUGPlacebo
Placebo will be administered intravenously once every 4 weeks.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
40 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
* Age 40-84 years (both inclusive) at the time of signing the informed consent * Documented symptomatic chronic heart failure (HF) diagnosed greater than or equal to (≥) 90 days prior to screening with at least weekly need for oral diuretic treatment, and New York Heart Association class II-III at screening * Clinically stable and on optimised doses and unchanged drug classes of guideline-directed HF therapy ≥45 days prior to randomisation * Left ventricular ejection fraction ≥50% as assessed by echocardiography at screening, measured by central laboratory * Left ventricular hypertrophy assessed by echocardiography at screening measured by central laboratory with any of the following: 1. LVMi (greater than) \>88 gram per square meter (g/m\^2) for female participants and \>102 g/m\^2 for male participants, using the truncated ellipsoid method measured by central laboratory 2. LVMi \>95 g/m2 for female participants and \>115 g/m2 for male participants using the linear method (cube formula). 3. Interventricular septum diameter measured in diastole (IVSd) in the parasternal long axis view ≥1.1 cm for female participants and ≥1.2 cm for male participants. * Body mass index 18.5-40 kilogram per square meter (kg/m\^2) (both inclusive) and body weight less than or equal to (≤) 140 kilogram (kg). Body mass index is calculated in the electronic case report form based on height and body weight at the screening visit (visit 1) * NT-proBNP ≥300 picograms per milliliter (pg/mL); NT-proBNP ≥600 pg/mL if atrial fibrillation/flutter is present at time of screening, measured by central laboratory
Exclusion criteria
* Estimated glomerular filtration rate lesser than (\<) 30 milliliter per minute (mL/min)/1.73 square meter (m\^2) at time of screening, measured by central laboratory * Participants with an episode of acute kidney failure or acute kidney injury, at the discretion of the investigator, within 90 days prior to randomisation * Myocardial infarction, unstable angina pectoris or HF hospitalisation within 30 days prior to screening * Participants receiving intravenous HF medications within 45 days prior to randomisation * Participants with CRT, pacemaker or implantable cardioverter-defibrillator * Planned coronary revascularisation, pacemaker/cardioverter-defibrillator/CRT implantation, ablation of cardiac arrythmias and valve repair/replacement at the time of randomisation * Stroke or transient ischemic attack within 12 months prior to randomisation * Participants with potential disruption of the blood-brain barrier (e.g., multiple sclerosis), in the opinion of the investigator * Known history of severe liver disease and/or alanine aminotransferase or aspartate aminotransferase \>2.5 x upper limit of normal at screening, measured by central laboratory * Known genetic (or highly suspected due to family history) cause of increased cardiac mass (including dilated cardiomyopathy, Fabry disease and likely pathogenic or pathogenic variants within hypertrophic cardiomyopathy \[HCM\]). * Participants with suspected or diagnosed cardiac amyloidosis or sarcoidosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Main phase: Change in normalised microRNA-132-3p (miR-132) | From baseline to week 24 | Measured as ratio to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Main phase: Change in composite Z-score based on the 3 outcome measures LVMi (CMR), LAVi (CMR) and NT-proBNP | From baseline to week 24 | The composite Z-score is calculated as the mean of the participant's 3 Z-scores for the change in the 3 outcome measures: left ventricular mass indexed to body surface area \[LVMi (Cardiovascular Magnetic Resonance \[CMR\])\], left atrial volume indexed to body surface area \[LAVi (CMR)\] and N-terminal pro B-type natriuretic peptide (NT-proBNP). |
| Main phase: Change in normalised miR-132 | From baseline to week 24 | Measured as ratio to baseline. |
| Main phase: Number of adverse events | From baseline to week 24 | Measured as count of events. |
| Extension phase: Number of adverse events | From baseline to week 60 | Measured as count of events. |
Countries
Canada, Germany, India, Japan, Poland, South Korea, Spain, United Kingdom, United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed