Status:
RECRUITING
A Research Study Comparing CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Heart Failure
Eligibility:
All Genders
40-84 years
Phase:
PHASE2
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 (...
Eligibility Criteria
Inclusion
- Age 40-84 years (both inclusive) at the time of signing the informed consent.
- Documented symptomatic heart failure (HF) diagnosed greater than or equal to (≥) 180 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 optimized doses and unchanged drug classes of guideline-directed HF therapy ≥ 45 days prior to randomisation.
- Left ventricular ejection fraction (LVEF) less than (\<) 50 percent (%) as assessed by echocardiography at screening, measured by central laboratory.
- Left ventricular mass indexed to body surface area (LVMi) greater than (\>) 88 gram per meter square (g/m\^2) for female participants and \>102 g/m\^2 for male participants as assessed by echocardiography at screening, using the truncated ellipsoid method measured by central laboratory.
- Left ventricular end-diastolic diameter indexed to body surface area (LVEDDi)≥3.0 cm/m\^2 for male participants and ≥3.1 centimeter per meter square (cm/m\^2) for female participants as assessed by echocardiography at screening, measured by central laboratory.
- Body mass index 18.5-40 kilogram per meter square (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).
- N-terminal pro B-type natriuretic peptide (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
- Estimated Glomerular Filtration Rate (eGFR) less than (\<) 30 milliliter/minute/ 1.73-meter square (mL/min/1.73 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 hospitalization within 30 days prior to screening.
- Participants receiving intravenous HF medications within 45 days prior to randomisation.
- Planned coronary revascularization, pacemaker/cardioverter-defibrillator/cardiac resynchronization therapy (CRT) implantation, ablation of cardiac arrythmias or 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 greater than (\>) 2.5x 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.
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 23 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06979375
Start Date
June 30 2025
End Date
January 23 2028
Last Update
December 31 2025
Active Locations (86)
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1
Concord Repatriation General Hospital - Cardiology Department
Concord, New South Wales, Australia, 2139
2
The Prince Charles Hospital
Brisbane, Queensland, Australia, 4032
3
Royal Adelaide Hospital Cardiovascular Clinical Trials
Adelaide, South Australia, Australia, 5000
4
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042