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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Novo Nordisk A/S • ClinicalTrials.gov ID: NCT06979362

Registry updated: 2026-10-05
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Description

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.

Interventions

  • CDR132L (Drug)
    CDR132L will be administered intravenously once every 4 weeks.
  • Placebo (Drug)
    Placebo will be administered intravenously once every 4 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/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.

Conditions

Heart Failure

Locations

  • Univ of Alabama Birmingham — Birmingham, Alabama, United States
  • TMC Hlthcr Clin Res Office — Tucson, Arizona, United States
  • Pima Heart and Vascular — Tucson, Arizona, United States
  • Valley Clinical Trials — Covina, California, United States
  • UCSD NAFLD Research Center — La Jolla, California, United States
  • Valley Clinical Trials — Northridge, 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
  • Univ of Colorado at Denver — Aurora, Colorado, United States
  • Inpatient Research Clinic LLC — Miami Lakes, Florida, United States
  • AdventHealth Orlando — Orlando, Florida, United States
  • Guardian Research Org LLC — Winter Park, Florida, United States
  • UofL Health Care Outpatient — Louisville, Kentucky, United States
  • Henry Ford Hospital_Detroit — Detroit, Michigan, United States
  • University of Minnesota_Minneapolis_1 — Minneapolis, Minnesota, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Icahn Sch of Med-Mt Sinai Hosp — New York, New York, United States
  • Duke University — Durham, North Carolina, United States
  • Providence St. Vincent Heart — Portland, Oregon, United States
  • Abington Memorial Hospital — Abington, Pennsylvania, United States
  • Capital Area Research LLC — Camp Hill, Pennsylvania, United States
  • Vanderbilt University Medical Center — Nashville, Tennessee, United States
  • Amarillo Medical Specialists — Amarillo, Texas, United States
  • University of Texas Southwestern Medical Center — Dallas, Texas, United States
  • Texama Medical Center — Denison, Texas, United States
  • East Texas Cardiology PA — Houston, Texas, United States
  • Inova Heart and Vascular Institute — Falls Church, Virginia, United States
  • Sentara Bayside Hospital — Norfolk, Virginia, United States
  • St Pauls Hospital — Vancouver, British Columbia, Canada
  • William Osler Hel Bra Civic Hs — Brampton, Ontario, Canada
  • Hamilton Hlth Sc. - General Site — Hamilton, Ontario, Canada
  • Hamilton General Hospital — Hamilton, Ontario, Canada
  • Premier Clinical Trial Research Network (PCTRN) — Hamilton, Ontario, Canada
  • Cardio Health Clinical Trials — Hamilton, Ontario, Canada
  • Cardio Health Clinical Trials — Mississauga, Ontario, Canada
  • University of Ottawa Heart Institute (UOHI) — Ottawa, Ontario, Canada
  • St. Michael's Hospital — Toronto, Ontario, Canada
  • Women's College Hospital — Toronto, Ontario, Canada
  • Winchester Dist Memorial Hosp — Winchester, Ontario, Canada
  • IUCPQ - Universite Laval — Québec, Canada
  • Sana Kliniken Berlin-Brandenburg GmbH - Lichtenberg — Berlin, Germany
  • Charité - Campus Benjamin Franklin - Klinik für Kardiologie — Berlin, Germany
  • Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU) — Berlin, Germany
  • Uniklinik TU Dresden - Herzzentrum Dresden GmbH — Dresden, Germany
  • Universitaetsklinikum Essen - Klinik für Kardiologie und Angiologie — Essen, Germany
  • Universitätsklinikum Frankfurt aM - Kardiologie — Frankfurt am Main, Germany
  • Universitätsklinikum Halle - Innere Medizin III — Halle, Germany
  • Medizinische Hochschule Hannover - Kardiologie und Angiologie — Hanover, Germany
  • UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie — Heidelberg, Germany
  • Uniklinik Schleswig-Holstein - Med. Klinik III Kardiologie und Internist. Intensivmedizin — Kiel, Germany
  • Rhythm Heart Institute - A unit of Synergy Lifecare Pvt — Vadodara, Gujarat, India
  • Sengupta Hospital and Research Institute — Nagpur, Maharashtra, India
  • All India Institute of Medical Sciences (AIIMS), Nagpur — Nagpur, Maharashtra, India
  • All India Institute of Medical Sciences (AIIMS), Nagpur — Nagpur, Maharashtra, India
  • G B Pant Institute of Postgraduate Medical Education and Research — New Delhi, National Capital Territory of Delhi, India
  • VMMC & Safdarjung Hospital — New Dehli, New Delhi, India
  • VMMC & Safdarjung Hospital — New Dehli, New Delhi, India
  • Government Siddhartha Medical College & Government General Hospital, Vijayawada — Vijayawada, NTR District, Andhra Pradesh, India
  • Apollo Hospital Chennai — Chennai, Tamil Nadu, India
  • Apollo Hospital Chennai — Chennai, Tamil Nadu, India
  • Osmania General Hospital — Hyderabad, Telangana, India
  • Osmania General Hospital — Hyderabad, Telangana, India
  • Shri Mahant Indiresh Hospital — Dehradun, Uttarakhand, India
  • IPGME&R and SSKM Hospital — Kolkata, West Bengal, India
  • Sir Ganga Ram Hospital-Cardiology — New Delhi, India
  • NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine — Bunkyo-ku, Tokyo, Japan
  • Fukuokaken Saiseikai Futsukaichi Hospital_Cardiology — Chikushino-shi, Fukuoka, Japan
  • Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology — Himeji-shi, Hyogo, Japan
  • National Hospital Organization Mito Medical Center_Cardiovascular medicine — Ibaraki, Japan
  • Mitoyo General Hospital_Cardiovascular medicine — Kagawa, Japan
  • Yokohama City University Medical Center_Cardiovascular Center — Kanagawa, Japan
  • Yokohama City University Medical Center_Cardiovascular Center — Kanagawa, Japan
  • Kagawa University Hospital_Cardiology — Kita-gun, Kagawa, Japan
  • Kobe City Medical Center General Hospital_Cardiology — Kobe-shi, Hyogo, Japan
  • Ome medical center_Cardiology — Ome-shi, Tokyo, Japan
  • Medical Research Institute KITANO HOSPITAL_Cardiovascular Medicine — Osaka-shi, Osaka, Japan
  • Osaka Metropolitan University Hospital_Cardiovascular Medicine — Osaka-Shi, Osaka, Japan
  • Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology — Sapporo-shi, Hokkaido, Japan
  • National Hospital Organization Yokohama Medical Center_Cardiology — Yokohama-shi, Kanagawa, Japan
  • 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu — Wroclaw, Lower Silesian Voivodeship, Poland
  • 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ — Lublin, Lublin Voivodeship, Poland
  • Uniwersytecki Szpital Kliniczny w Bialymstoku — Bialystok, Podlaskie Voivodeship, Poland
  • Pomorski Uniwersytet Medyczny — Szczecin, West Pomeranian Voivodeship, Poland
  • American Heart of Poland S.A. — Bielsko-Biala, Poland
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie — Krakow, Poland
  • Krakowski Szpital Specjalistyczny im. Jana Pawla II — Krakow, Poland
  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. — Krakow, Poland
  • Instytut Centrum Zdrowia Matki Polki — Lodz, Poland
  • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie — Lublin, Poland
  • Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu — Przemyśl, Poland
  • Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy — Warsaw, Poland
  • Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu — Wroclaw, Poland
  • Slaskie Centrum Chorob Serca W Zabrzu — Zabrze, Poland
  • Chungbuk National University Hospital — Cheongju-si, South Korea
  • Keimyung University Dongsan Hospital — Daegu, South Korea
  • Wonju Severance Christian Hospital — Gangwon-do, South Korea
  • Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea
  • Kyunghee University Medical Center — Seoul, South Korea
  • Korea University Anam Hospital — Seoul, South Korea
  • Korea University Guro Hospital — Seoul, South Korea
  • Korea University Guro Hospital — Seoul, South Korea
  • Hospital Universitario San Cecilio — Granada, Andalusia, Spain
  • Hospital Univ. Virgen de la Arrixaca — El Palmar, Murcia, Spain
  • Hospital del Mar — Barcelona, Spain
  • Hosp. U Gran Canaria Dr. Negrín_Cardiologia — Las Palmas de Gran Canaria, Spain
  • Hospital Univ. La Luz_Cardiología — Madrid, Spain
  • Hospital Ramón y Cajal_Cardiología — Madrid, Spain
  • Hospital Universitario La Paz — Madrid, Spain
  • Hospital Clinico Universitario de Valencia — Valencia, Spain
  • Trialmed - Midlands — Birmingham, United Kingdom
  • Wycombe General Hospital — High Wycombe, United Kingdom
  • St Bartholomew's Hospital - Cardiac Research Office — London, United Kingdom
  • St Bartholomew's Hospital - Cardiology — London, United Kingdom
  • King's College Hospital — London, United Kingdom
  • The Royal Brompton Hospital - Respiratory CRF — London, United Kingdom
  • The James Cook University Hospital - Cardiology — Middlesbrough, United Kingdom
  • Southampton General Hospital — Southampton, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record