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RECRUITING

NCT06979375

PHASE2

A Research Study Comparing CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

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.

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 Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy

Key Details

Gender

All

Age Range

40 Years - 84 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-06-30

Completion Date

2028-01-23

Last Updated

2026-03-11

Healthy Volunteers

Conditions

Heart Failure

Interventions

DRUG

CDR132L

Administered intravenous infusion of CDR132L once every 4 weeks for 48 weeks.

DRUG

Placebo

Administered intravenous infusion of placebo once every 4 weeks for 48 weeks.

Inclusion Criteria: * Age 40-84 years (both inclusive) at the time of signing the informed consent. * Documented symptomatic heart failure (HF) diagnosed greater than or equal to (≥) 180 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 optimized doses and unchanged drug classes of guideline-directed HF therapy ≥ 45 days prior to randomisation. * Left ventricular ejection fraction (LVEF) less than (\<) 50 percent (%) as assessed by echocardiography at screening, measured by central laboratory. * Left ventricular hypertrophy or left ventricular dilatation assessed by echocardiography at screening measured by central laboratory with any of the following: 1. LVMi greater than (\>)88 g/m\^2 for female participants and \>102 g/m\^2 for male participants using the truncated ellipsoid method. 2. LVMi \>95 g/m\^2 for female participants and \>115 g/m\^2 for male participants, using the linear method (cube formula). 3. Left ventricular end-diastolic diameter indexed to body surface area (LVEDDi) \>3.1 cm/m\^2 for female participants and \>3.0 cm/m\^2 for male participants. * Body mass index 18.5-40 kilogram per meter square (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). * N-terminal pro B-type natriuretic peptide (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 (eGFR) less than (\<) 30 milliliter/minute/ 1.73-meter square (mL/min/1.73 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 hospitalization within 30 days prior to screening. * Participants receiving intravenous HF medications within 45 days prior to randomisation. * Planned coronary revascularization, pacemaker/cardioverter-defibrillator/cardiac resynchronization therapy (CRT) implantation, ablation of cardiac arrythmias or 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 greater than (\>) 2.5x 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.

Locations (92)

Concord Repatriation General Hospital - Cardiology Department

Concord, New South Wales, Australia

The Prince Charles Hospital

Brisbane, Queensland, Australia

Royal Adelaide Hospital - Cardiology Department

Adelaide, South Australia, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

Victorian Heart Hospital

Clayton, Victoria, Australia

Fiona Stanley Hospital - Cardiology

Murdoch, Western Australia, Australia

Fakultní nemocnice u sv. Anny v Brně

Brno, Czechia

Nemocnice České Budějovice a.s.

České Budějovice, Czechia

Fakultní Nemocnice Ostrava

Ostrava-Poruba, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Pratia Prague, s.r.o

Prague, Czechia

IKEM

Prague, Czechia

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

Vadodara, Gujarat, India

Lisie Hospital

Kochi, Kerala, India

Seth GS Medical College & KEM Hospital

Mumbai, Maharashtra, India

Arneja Heart & Multispeciality Hospital

Nagpur, Maharashtra, India

Arneja Heart & Multispeciality Hospital

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

Dayanand Medical College & Hospital

Ludhiana, Punjab, India

Shri Mahant Indiresh Hospital

Dehradun, Uttarakhand, India

Sir Ganga Ram Hospital-Cardiology

New Delhi, India

Sir Ganga Ram Hospital-Cardiology

New Delhi, India

NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine

Bunkyo-ku, Tokyo, Japan

JA Shizuoka Kohseiren Enshu Hospital_ Cardiology

Hamamatsu-shi, Shizuoka, Japan

Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology

Himeji-shi, Hyogo, Japan

National Hospital Organization Mito Medical Center_Cardiovascular medicine

Ibaraki, 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

The University of Osaka Hospital_Cardiovascular medicine

Osaka, 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

AmsterdamUMC AMC

Amsterdam, Netherlands

Zuyderland ziekenhuis - Cardiologie

Heerlen, Netherlands

Radboudumc

Nijmegen, Netherlands

Erasmus MC

Rotterdam, Netherlands

VieCuri - Cardiologie

Venlo, Netherlands

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

Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej

Biała Podlaska, Poland

American Heart of Poland S.A.

Bielsko-Biala, Poland

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, Poland

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.

Krakow, 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

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

Korea University Anam Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

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. de Gerona Doctor Josep Trueta

Girona, Catalonia, Spain

Hospital Univ. Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital del Mar

Barcelona, Spain

Hospital de Dénia_Cardiología

Denia, Spain

Hospital Virgen de la Arrixaca

El Palmar, Spain

Hospital Univ. de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Spain

Hospital Ramón y Cajal_Cardiología

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

H. Clinico Univ. Virgen de la Victoria

Málaga, Spain

Hospital Universitario Virgen del Rocío

Seville, 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

Kings 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

Clinical Research Directory

A Research Study Comparing CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (92)