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CDR132L versus placebo to improve heart structure and function in people with heart failure and left ventricular hypertrophy

Phase 2, Multicentre, Randomised, Double-blind, Placebo-controlled Safety and Efficacy Study of CDR132L on Reverse Cardiac Remodelling in Participants With Heart Failure With Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy

Phase 2 Interventional Novo Nordisk A/S · NCT06979375

This trial will try CDR132L to see if it improves heart structure and function compared with placebo in people aged 40–84 who have chronic heart failure with reduced or mildly reduced ejection fraction and left ventricular hypertrophy.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment200 (estimated)
Ages40 Years to 84 Years
SexAll
SponsorNovo Nordisk A/S Industry-sponsored
Locations92 sites (Concord, New South Wales and 91 other locations)
Trial IDNCT06979375 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, randomized, placebo-controlled interventional trial testing CDR132L over about 60 weeks in people with symptomatic chronic heart failure, LVEF <50%, and echocardiographic left ventricular hypertrophy. Participants who meet entry criteria and are stable on guideline-directed heart failure therapy are randomly assigned to receive CDR132L or a matching placebo. Cardiac structure and function will be measured centrally by echocardiography and other standardized assessments during scheduled study visits. The trial is being run at several tertiary hospitals in Australia and is sponsored by Novo Nordisk.

Who should consider this trial

Good fit: Adults aged 40–84 with symptomatic chronic heart failure (NYHA II–III) for at least 180 days, LVEF <50% on central echo, documented left ventricular hypertrophy, and stable optimized guideline-directed therapy are the intended participants.

Not a fit: People with preserved ejection fraction (LVEF ≥50%), recent unstable or decompensated heart failure, those outside the 40–84 age range, or without LV hypertrophy are unlikely to be eligible or to benefit from this treatment.

Why it matters

Potential benefit: If successful, CDR132L could improve cardiac structure and function and slow progression of heart failure in patients with reduced or mildly reduced ejection fraction and LV hypertrophy.

How similar studies have performed: Early-phase human studies of CDR132L have suggested acceptable safety and biological activity, but larger trials are needed to demonstrate clear clinical benefit.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 hypertrophy or left ventricular dilatation assessed by echocardiography at screening measured by central laboratory with any of the following:

  1. LVMi greater than (\>)88 g/m\^2 for female participants and \>102 g/m\^2 for male participants using the truncated ellipsoid method.
  2. LVMi \>95 g/m\^2 for female participants and \>115 g/m\^2 for male participants, using the linear method (cube formula).
  3. Left ventricular end-diastolic diameter indexed to body surface area (LVEDDi) \>3.1 cm/m\^2 for female participants and \>3.0 cm/m\^2 for male participants.
* 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 Criteria:

* 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.

Where this trial is running

Concord, New South Wales and 91 other locations

+42 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart Failure
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.