NCT06979362RecruitingPhase 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
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
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 16 May 2025
- Start date
- 27 Jun 2025
- Primary completion date
- 16 Nov 2027
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Heart failure
- NCT number
- NCT06979362
- EU CT number
- 2024-515796-35-00
- EudraCT number
- 2024-515796-35
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 27 Jun 2025 to the primary completion date, 16 Nov 2027
- 109 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Stroke or transient ischemic attack within 12 months prior to randomisation
Other illness
- Planned coronary revascularisation, pacemaker/cardioverter-defibrillator/CRT implantation, ablation of cardiac arrythmias and valve repair/replacement at the time of randomisation
- 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.
Lab values
- 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
- 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
Other
- Participants with CRT, pacemaker or implantable cardioverter-defibrillator
- Participants with potential disruption of the blood-brain barrier (e.g., multiple sclerosis), in the opinion of the investigator
Who the study is looking for
- 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:
- 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
- LVMi \>95 g/m2 for female participants and \>115 g/m2 for male participants using the linear method (cube formula).
- 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
Age in the registry: 40 years to 84 years · Sex: All · Does not accept healthy volunteers
Sites (109)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| William Osler Hel Bra Civic Hs Coordinator of this site? Confirm its status | Brampton | Canada | Not yet recruiting |
| Cardio Health Clinical Trials Coordinator of this site? Confirm its status | Hamilton | Canada | Not yet recruiting |
| Hamilton Hlth Sc. - General Site Coordinator of this site? Confirm its status | Hamilton | Canada | Not yet recruiting |
| Hamilton General Hospital Coordinator of this site? Confirm its status | Hamilton | Canada | Completed |
| Premier Clinical Trial Research Network (PCTRN) Coordinator of this site? Confirm its status | Hamilton | Canada | Not yet recruiting |
| Cardio Health Clinical Trials Coordinator of this site? Confirm its status | Mississauga | Canada | Recruiting |
| University of Ottawa Heart Institute (UOHI) Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| IUCPQ-Universite Laval Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Not yet recruiting |
| Women's College Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Not yet recruiting |
| St Pauls Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Completed |
| Winchester Dist Memorial Hosp Coordinator of this site? Confirm its status | Winchester | Canada | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Herzzentrum Dresden GmbH Universitaetsklinik Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Universitaetsklinikum Frankfurt AöR Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Recruiting |
| Universitaetsklinikum Halle (Saale) AöR Coordinator of this site? Confirm its status | Halle Saale | Germany | Recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Clínico San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Recruiting |
| El Hospital Universitario De Gran Canaria Dr. Negrin Coordinator of this site? Confirm its status | Las Palmas De Gran Canaria | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Trialmed - Midlands Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| Wycombe General Hospital Coordinator of this site? Confirm its status | High Wycombe | United Kingdom | Recruiting |
| The Royal Brompton Hospital - Respiratory CRF Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| St Bartholomew's Hospital - Cardiology Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| St Bartholomew's Hospital - Cardiac Research Office Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| King's College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The James Cook University Hospital - Cardiology Coordinator of this site? Confirm its status | Middlesbrough | United Kingdom | Recruiting |
| Southampton General Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Recruiting |
| Apollo Hospital Chennai Coordinator of this site? Confirm its status | Chennai | India | Recruiting |
| Shri Mahant Indiresh Hospital Coordinator of this site? Confirm its status | Dehradun | India | Recruiting |
| Osmania General Hospital Coordinator of this site? Confirm its status | Hyderabad | India | Recruiting |
| IPGME&R and SSKM Hospital Coordinator of this site? Confirm its status | Kolkata | India | Recruiting |
| Sengupta Hospital and Research Institute Coordinator of this site? Confirm its status | Nagpur | India | Recruiting |
| All India Institute of Medical Sciences (AIIMS) - Nagpur Coordinator of this site? Confirm its status | Nagpur | India | Recruiting |
| VMMC & Safdarjung Hospital Coordinator of this site? Confirm its status | New Dehli | India | Recruiting |
| Sir Ganga Ram Hospital-Cardiology Coordinator of this site? Confirm its status | New Delhi | India | Recruiting |
| G B Pant Institute of Postgraduate Medical Education and Research Coordinator of this site? Confirm its status | New Delhi | India | Recruiting |
| Rhythm Heart Institute - A unit of Synergy Lifecare Pvt Coordinator of this site? Confirm its status | Vadodara | India | Recruiting |
| Government Siddhartha Medical College & Government General Hospital, Vijayawada Coordinator of this site? Confirm its status | Vijayawada | India | Recruiting |
| NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine Coordinator of this site? Confirm its status | Bunkyo-ku, Tokyo | Japan | Recruiting |
| Fukuokaken Saiseikai Futsukaichi Hospital_Cardiology Coordinator of this site? Confirm its status | Chikushino-shi, Fukuoka | Japan | Not yet recruiting |
| Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology Coordinator of this site? Confirm its status | Himeji-shi, Hyogo | Japan | Recruiting |
| National Hospital Organization Mito Medical Center_Cardiovascular medicine Coordinator of this site? Confirm its status | Ibaraki | Japan | Recruiting |
| Mitoyo General Hospital_Cardiovascular medicine Coordinator of this site? Confirm its status | Kagawa | Japan | Not yet recruiting |
| Yokohama City University Medical Center_Cardiovascular Center Coordinator of this site? Confirm its status | Kanagawa | Japan | Recruiting |
| Kagawa University Hospital_Cardiology Coordinator of this site? Confirm its status | Kita-gun, Kagawa | Japan | Completed |
| Kobe City Medical Center General Hospital_Cardiology Coordinator of this site? Confirm its status | Kobe-shi, Hyogo | Japan | Recruiting |
| Ome medical center_Cardiology Coordinator of this site? Confirm its status | Ome-shi, Tokyo | Japan | Recruiting |
| Medical Research Institute KITANO HOSPITAL_Cardiovascular Medicine Coordinator of this site? Confirm its status | Osaka-shi, Osaka | Japan | Recruiting |
| Osaka Metropolitan University Hospital_Cardiovascular Medicine Coordinator of this site? Confirm its status | Osaka-Shi, Osaka | Japan | Recruiting |
| Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology Coordinator of this site? Confirm its status | Sapporo-shi, Hokkaido | Japan | Recruiting |
| National Hospital Organization Yokohama Medical Center_Cardiology Coordinator of this site? Confirm its status | Yokohama-shi, Kanagawa | Japan | Recruiting |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Recruiting |
| Keimyung University Dongsan Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Wonju Severance Christian Hospital Coordinator of this site? Confirm its status | Gangwon-do | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si, Gyeonggi-do | South Korea | Completed |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Completed |
| KyungHee University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| American Heart of Poland S.A. Coordinator of this site? Confirm its status | Bielsko-Biala | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Institute Of Polish Mother's Health Center Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| 1. Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Wojewodzki Szpital im Sw Ojca Pio w Przemyslu Coordinator of this site? Confirm its status | Przemyśl | Poland | Recruiting |
| Pomeranian Medical University Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclaw Coordinator of this site? Confirm its status | Wrocław | Poland | Recruiting |
| Śląskie Centrum Chorób Serca w Zabrzu Coordinator of this site? Confirm its status | Zabrze | Poland | Recruiting |
| Abington Memorial Hospital Coordinator of this site? Confirm its status | Abington | United States | Completed |
| Amarillo Medical Specialists Coordinator of this site? Confirm its status | Amarillo | United States | Recruiting |
| Univ of Colorado at Denver Coordinator of this site? Confirm its status | Aurora | United States | Not yet recruiting |
| Univ of Alabama Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Capital Area Research, LLC Coordinator of this site? Confirm its status | Camp Hill | United States | Recruiting |
| Valley Clinical Trials Coordinator of this site? Confirm its status | Covina | United States | Recruiting |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Texama Medical Center Coordinator of this site? Confirm its status | Denison | United States | Not yet recruiting |
| Henry Ford Hospital_Detroit Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Inova Heart and Vascular Institute Coordinator of this site? Confirm its status | Falls Church | United States | Recruiting |
| East Texas Cardiology PA Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| UCSD NAFLD Research Center Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| UofL Health Care Outpatient Coordinator of this site? Confirm its status | Louisville | United States | Not yet recruiting |
| Inpatient Research Clinic LLC Coordinator of this site? Confirm its status | Miami Lakes | United States | Recruiting |
| University of Minnesota_Minneapolis_1 Coordinator of this site? Confirm its status | Minneapolis | United States | Completed |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Icahn Sch of Med-Mt Sinai Hosp Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| Sentara Bayside Hospital Coordinator of this site? Confirm its status | Norfolk | United States | Completed |
| Valley Clinical Trials Coordinator of this site? Confirm its status | Northridge | United States | Recruiting |
| AdventHealth Orlando Coordinator of this site? Confirm its status | Orlando | United States | Not yet recruiting |
| Providence St. Vincent Heart Coordinator of this site? Confirm its status | Portland | United States | Completed |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| University of California, San Francisco (UCSF) Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Harbor-UCLA Medical Center Coordinator of this site? Confirm its status | Torrance | United States | Recruiting |
| PIMA Heart and Vascular Coordinator of this site? Confirm its status | Tucson | United States | Not yet recruiting |
| TMC Hlthcr Clin Res Office Coordinator of this site? Confirm its status | Tucson | United States | Not yet recruiting |
| Guardian Research Org LLC Coordinator of this site? Confirm its status | Winter Park | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.