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

Phase 2

Not yet recruiting

• Conditions: Heart Failure
• Interventions: Drug: CDR132L; Drug: Placebo

• Registration Number: NCT06979362
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-16
• Study First Submitted QC: 2025-05-16
• Last Update Submitted: 2025-05-16
• Study First Posted: 2025-05-19
• Last Update Posted: 2025-05-19
• Study Start: 2025-07-01
• Primary Completion: 2027-05-16
• Study Completion: 2028-01-23

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 ≥30 days prior to randomisation
• Left ventricular ejection fraction ≥50% as assessed by echocardiography at screening, measured by central laboratory
• LVMi (greater than) >88 gram per square meter (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
• LAVi ≥29 milliliter per square meter (mL/m^2) as assessed by echocardiography at screening, measured by central laboratory
• 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 30 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 cause of increased cardiac mass (including likely pathogenic variants within dilated cardiomyopathy, hypertrophic cardiomyopathy and Fabry disease)
• Participants with suspected or diagnosed cardiac amyloidosis or sarcoidosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDR132L: Dose 1	CDR132L	Participants will receive intravenous infusion of CDR132L dose 1 once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure.
CDR132L: Dose 2	CDR132L	Participants will receive intravenous infusion of CDR132L dose 2 once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure.
CDR132L: Dose 3	CDR132L	Participants will receive intravenous infusion of CDR132L dose 3 once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure.
Placebo	Placebo	Participants will receive intravenous infusion of placebo once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure.

Primary Outcome Measures

Name	Time	Method
Main phase: Change in microRNA-132-3p (miR-132)	From baseline to week 24	Measured as ratio to baseline.

Secondary Outcome Measures

Name	Time	Method
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).
Extension phase: Number of adverse events	From baseline to week 60	Measured as count of events.
Main phase: Change in 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.

Trial Locations

Locations (83)

Univ of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

Pima Heart and Vascular; 🇺🇸 Tucson, Arizona, United States

Valley Clinical Trials; 🇺🇸 Northridge, California, United States

UCSD NAFLD Research Center; 🇺🇸 La Jolla, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of California San Francisco UCSF; 🇺🇸 San Francisco, California, United States

Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

CPC Clinical Research & Community Health; 🇺🇸 Aurora, Colorado, United States

Inpatient Research Clinic LLC; 🇺🇸 Miami Lakes, Florida, United States

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States

Scroll for more (73 remaining)