Actively Recruiting
Phase 2 Randomized, Double-blind, Placebo-controlled Study of CDR132L on Heart Structure and Function in Heart Failure Patients with Preserved Ejection Fraction and Left Ventricular Hypertrophy
Led by Novo Nordisk A/S · Updated on 2026-03-11
200
Participants Needed
109
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how CDR132L, a potential new medicine, affects the structure and function of the heart in people living with heart failure who have preserved ejection fraction and left ventricular hypertrophy. The study is a Phase 2, randomized, placebo-controlled trial lasting about 60 weeks, aiming to understand the impact of different doses of CDR132L on heart remodeling and related biomarkers. Participants will be randomly assigned to receive one of three different doses of CDR132L or a placebo. Each treatment is given as an intravenous infusion once every four weeks for 48 weeks. Alongside the study treatment, participants will continue their individually adjusted standard care therapy for heart failure. The trial includes a main phase and an extension phase to monitor effects over time. During the study, participants will undergo various assessments including measurement of microRNA-132-3p levels from baseline to week 24, heart imaging scans to evaluate changes in heart muscle and atrial volume, and monitoring of NT-proBNP levels, a marker of heart failure. Safety is closely tracked by recording adverse events during both the main and extension phases. The entire participation period spans approximately 60 weeks, with ongoing evaluation of the hearts structure and function.
CONDITIONS
Brief Title
A Research Study Comparing Different Doses of CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Preserved Ejection Fraction and Left Ventricular Hypertrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 to 84 years at the time of signing informed consent
- Documented symptomatic chronic heart failure diagnosed at least 90 days before screening with at least weekly need for oral diuretics
- New York Heart Association class II-III at screening
- Clinically stable and on optimized doses of guideline-directed heart failure therapy for at least 45 days before randomization
- Left ventricular ejection fraction 50% or higher by echocardiography at screening
- Left ventricular hypertrophy confirmed by echocardiography with specified measurements depending on sex
- Body mass index between 18.5 and 40 kg/m2 and body weight up to 140 kg
- NT-proBNP 300 pg/mL or higher; if atrial fibrillation/flutter is present, NT-proBNP 600 pg/mL or higher
You will not qualify if you...
- Estimated glomerular filtration rate less than 30 mL/min/1.73 m2 at screening
- Episode of acute kidney failure or injury within 90 days before randomization
- Myocardial infarction, unstable angina, or heart failure hospitalization within 30 days before screening
- Receiving intravenous heart failure medications within 45 days before randomization
- Presence of CRT, pacemaker, or implantable cardioverter-defibrillator
- Planned coronary revascularization, device implantation, ablation, or valve repair at randomization
- Stroke or transient ischemic attack within 12 months before randomization
- Potential blood-brain barrier disruption conditions like multiple sclerosis
- Severe liver disease or elevated liver enzymes over 2.5 times the upper limit of normal
- Known or suspected genetic causes of increased cardiac mass such as dilated cardiomyopathy or Fabry disease
- Suspected or diagnosed cardiac amyloidosis or sarcoidosis
Research Team
N
Novo Nordisk
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