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Clinical Trials in the UK / NCT06979362
Recruiting Phase 2

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

NCT06979362 · tracked via the Priya Life Science UK tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 2
Started
2025-06-27
Last updated
2026-08-05

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

CDR132LPlacebo

CDR132L: CDR132L will be administered intravenously once every 4 weeks.

Placebo: Placebo will be administered intravenously once every 4 weeks.

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
84 Years
Healthy volunteers
No
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 ≥45 days prior to randomisation * Left ventricular ejection fraction ≥50% 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 18.5-40 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 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.

Primary outcome measure(s)

Trial sites (117)

FacilityCityRegionStatus
Univ of Alabama Birmingham Birmingham Alabama Recruiting
TMC Hlthcr Clin Res Office Tucson Arizona Not Yet Recruiting
Pima Heart and Vascular Tucson Arizona Not Yet Recruiting
Valley Clinical Trials Covina California Recruiting
UCSD NAFLD Research Center La Jolla California Recruiting
Valley Clinical Trials Northridge California Recruiting
University of California, San Francisco San Francisco California Recruiting
University of California San Francisco UCSF San Francisco California Recruiting
Harbor-UCLA Medical Center Torrance California Recruiting
Univ of Colorado at Denver Aurora Colorado Not Yet Recruiting
Inpatient Research Clinic LLC Miami Lakes Florida Recruiting
AdventHealth Orlando Orlando Florida Not Yet Recruiting
Guardian Research Org LLC Winter Park Florida Not Yet Recruiting
UofL Health Care Outpatient Louisville Kentucky Not Yet Recruiting
Henry Ford Hospital_Detroit Detroit Michigan Recruiting
University of Minnesota_Minneapolis_1 Minneapolis Minnesota Completed
Washington University School of Medicine St Louis Missouri Recruiting
Icahn Sch of Med-Mt Sinai Hosp New York New York Not Yet Recruiting
Duke University Durham North Carolina Recruiting
Providence St. Vincent Heart Portland Oregon Completed
Abington Memorial Hospital Abington Pennsylvania Completed
Capital Area Research LLC Camp Hill Pennsylvania Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Amarillo Medical Specialists Amarillo Texas Not Yet Recruiting
University of Texas Southwestern Medical Center Dallas Texas Recruiting
Texama Medical Center Denison Texas Not Yet Recruiting
East Texas Cardiology PA Houston Texas Recruiting
Inova Heart and Vascular Institute Falls Church Virginia Recruiting
Sentara Bayside Hospital Norfolk Virginia Completed
St Pauls Hospital Vancouver British Columbia Completed
William Osler Hel Bra Civic Hs Brampton Ontario Not Yet Recruiting
Hamilton Hlth Sc. - General Site Hamilton Ontario Not Yet Recruiting
Hamilton General Hospital Hamilton Ontario Completed
Premier Clinical Trial Research Network (PCTRN) Hamilton Ontario Not Yet Recruiting
Cardio Health Clinical Trials Hamilton Ontario Not Yet Recruiting
Cardio Health Clinical Trials Mississauga Ontario Recruiting
University of Ottawa Heart Institute (UOHI) Ottawa Ontario Recruiting
St. Michael's Hospital Toronto Ontario Not Yet Recruiting
Women's College Hospital Toronto Ontario Not Yet Recruiting
Winchester Dist Memorial Hosp Winchester Ontario Recruiting

+ 77 more sites — see the full list on the official registry below.

More Novo Nordisk A/S trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06979362 on ClinicalTrials.gov ↗ ← All trials in the UK