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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 · Novo Nordisk A/S
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Official title
Phase 2, Multicentre, Randomised, Double-blind, Placebo-controlled Safety and Efficacy Study of CDR132L on Reverse Cardiac Remodelling in Participants With Heart Failure With Preserved Ejection Fraction and Left Ventricular Hypertrophy
About this study
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 criteria
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.
Study design
Enrollment target: 200 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-06-27
Estimated completion: 2028-01-23
Last updated: 2026-03-11
Interventions
Drug: CDR132LDrug: Placebo
Primary outcomes
  • Main phase: Change in normalised microRNA-132-3p (miR-132) (From baseline to week 24)
Sponsor
Novo Nordisk A/S · industry
Contacts & investigators
ContactNovo Nordisk · contact · clinicaltrials@novonordisk.com · (+1) 866-867-7178
InvestigatorClinical Transparency (dept. 2834) · study_director, Novo Nordisk A/S
All locations (109)
Univ of Alabama BirminghamRecruiting
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Guardian Research Org LLCNot Yet Recruiting
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UofL Health Care OutpatientNot Yet Recruiting
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Henry Ford Hospital_DetroitRecruiting
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University of Minnesota_Minneapolis_1Completed
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Washington University School of MedicineNot Yet Recruiting
St Louis, Missouri, United States
Icahn Sch of Med-Mt Sinai HospNot Yet Recruiting
New York, New York, United States
Duke UniversityNot Yet Recruiting
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Providence St. Vincent HeartCompleted
Portland, Oregon, United States
Abington Memorial HospitalCompleted
Abington, Pennsylvania, United States
Capital Area Research LLCRecruiting
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Vanderbilt University Medical CenterNot Yet Recruiting
Nashville, Tennessee, United States
Amarillo Medical SpecialistsNot Yet Recruiting
Amarillo, Texas, United States
University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States
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Denison, Texas, United States
East Texas Cardiology PARecruiting
Houston, Texas, United States
Inova Heart and Vascular InstituteNot Yet Recruiting
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Sentara Bayside HospitalCompleted
Norfolk, Virginia, United States
St Pauls HospitalCompleted
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William Osler Hel Bra Civic HsNot Yet Recruiting
Brampton, Ontario, Canada
Hamilton Hlth Sc. - General SiteNot Yet Recruiting
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Hamilton General HospitalCompleted
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Mississauga, Ontario, Canada
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Women's College HospitalNot Yet Recruiting
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Winchester Dist Memorial HospRecruiting
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Sana Kliniken Berlin-Brandenburg GmbH - LichtenbergCompleted
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Berlin, Germany
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Dresden, Germany
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Essen, Germany
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Frankfurt am Main, Germany
Universitätsklinikum Halle - Innere Medizin IIIRecruiting
Halle, Germany
Medizinische Hochschule Hannover - Kardiologie und AngiologieRecruiting
Hanover, Germany
UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, PneumologieRecruiting
Heidelberg, Germany
Uniklinik Schleswig-Holstein - Med. Klinik III Kardiologie und Internist. IntensivmedizinRecruiting
Kiel, Germany
Rhythm Heart Institute - A unit of Synergy Lifecare PvtRecruiting
Vadodara, Gujarat, India
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All India Institute of Medical Sciences (AIIMS), NagpurRecruiting
Nagpur, Maharashtra, India
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Nagpur, Maharashtra, India
G B Pant Institute of Postgraduate Medical Education and ResearchRecruiting
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New Dehli, New Delhi, India
Apollo Hospital ChennaiRecruiting
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Himeji-shi, Hyogo, Japan
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Kanagawa, Japan
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Kanagawa, Japan
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Kobe-shi, Hyogo, Japan
Medical Research Institute KITANO HOSPITAL_Cardiovascular MedicineRecruiting
Osaka-shi, Osaka, Japan
Osaka Metropolitan University Hospital_Cardiovascular MedicineRecruiting
Osaka-Shi, Osaka, Japan
Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism EndocrinologyRecruiting
Sapporo-shi, Hokkaido, Japan
National Hospital Organization Yokohama Medical Center_CardiologyRecruiting
Yokohama-shi, Kanagawa, Japan
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We WroclawiuRecruiting
Wroclaw, Lower Silesian Voivodeship, Poland
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Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w KrakowieNot Yet Recruiting
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Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut BadawczyRecruiting
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Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We WroclawiuRecruiting
Wroclaw, Poland
Chungbuk National University HospitalRecruiting
Cheongju-si, South Korea
Keimyung University Dongsan HospitalRecruiting
Daegu, South Korea
Wonju Severance Christian HospitalRecruiting
Gangwon-do, South Korea
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Seongnam-si, Gyeonggi-do, South Korea
Korea University Anam HospitalRecruiting
Seoul, South Korea
Korea University Guro HospitalCompleted
Seoul, South Korea
Korea University Guro HospitalWithdrawn
Seoul, South Korea
Hospital Universitario San CecilioRecruiting
Granada, Andalusia, Spain
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El Palmar, Murcia, Spain
Hospital del MarRecruiting
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Las Palmas de Gran Canaria, Spain
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Madrid, Spain
Hospital Universitario La PazRecruiting
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Hospital Clinico Universitario de ValenciaRecruiting
Valencia, Spain
Trialmed - MidlandsRecruiting
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Wycombe General HospitalNot Yet Recruiting
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St Bartholomew's Hospital - Cardiac Research OfficeNot Yet Recruiting
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Kings College HospitalRecruiting
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The James Cook University Hospital - CardiologyRecruiting
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Southampton General HospitalNot Yet Recruiting
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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 · TrialPath