Different doses of CDR132L versus placebo for heart structure and function in people with HFpEF and left ventricular hypertrophy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled Phase 2 trial will assign adults with symptomatic chronic heart failure (LVEF ≥50%) and echocardiographic left ventricular hypertrophy to receive one of several doses of CDR132L or placebo for about 60 weeks. Participants must be clinically stable, on unchanged guideline-directed heart failure therapy for at least 45 days, and have had heart failure symptoms for at least 90 days. Heart structure and function will be measured by centralized echocardiography and other clinical assessments over the treatment period. The goal is to determine dose effects of CDR132L on cardiac remodeling and function compared with placebo.

Why it matters

Who can join: the full rules

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/or a sodium-glucose cotransporter-2 inhibitor (SGLT2i), 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 ≥40% 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 18.5-45 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.

Where it's running

• Univ of Alabama Birmingham
  Birmingham, Alabama, United States Recruiting
• Valley Clinical Trials
  Covina, California, United States Recruiting
• UCSD NAFLD Research Center
  La Jolla, California, United States Recruiting
• Valley Clinical Trials
  Northridge, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• University of California San Francisco UCSF
  San Francisco, California, United States Recruiting

+68 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.