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Clinical Trials in India / NCT06979375
Recruiting Phase 2

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

NCT06979375 · tracked via the Priya Life Science India tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 2
Started
2025-06-30
Last updated
2026-03-11

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

CDR132LPlacebo

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

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

Primary outcome measure(s)

Trial sites (92)

FacilityCityRegionStatus
Concord Repatriation General Hospital - Cardiology Department Concord New South Wales Recruiting
The Prince Charles Hospital Brisbane Queensland Not Yet Recruiting
Royal Adelaide Hospital - Cardiology Department Adelaide South Australia Recruiting
Flinders Medical Centre Bedford Park South Australia Recruiting
Royal Hobart Hospital Hobart Tasmania Recruiting
Victorian Heart Hospital Clayton Victoria Recruiting
Fiona Stanley Hospital - Cardiology Murdoch Western Australia Recruiting
Fakultní nemocnice u sv. Anny v Brně Brno Czechia Completed
Nemocnice České Budějovice a.s. České Budějovice Czechia Recruiting
Fakultní Nemocnice Ostrava Ostrava-Poruba Czechia Recruiting
Vseobecna fakultni nemocnice v Praze Prague Czechia Recruiting
Pratia Prague, s.r.o Prague Czechia Not Yet Recruiting
IKEM Prague Czechia Recruiting
Sana Kliniken Berlin-Brandenburg GmbH - Lichtenberg Berlin Germany Completed
Charité - Campus Benjamin Franklin - Klinik für Kardiologie Berlin Germany Not Yet Recruiting
Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU) Berlin Germany Recruiting
Uniklinik TU Dresden - Herzzentrum Dresden GmbH Dresden Germany Recruiting
Universitaetsklinikum Essen - Klinik für Kardiologie und Angiologie Essen Germany Not Yet Recruiting
Universitätsklinikum Frankfurt aM - Kardiologie Frankfurt am Main Germany Recruiting
Universitätsklinikum Halle - Innere Medizin III Halle Germany Recruiting
Medizinische Hochschule Hannover - Kardiologie und Angiologie Hanover Germany Recruiting
UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie Heidelberg Germany Recruiting
Uniklinik Schleswig-Holstein - Med. Klinik III Kardiologie und Internist. Intensivmedizin Kiel Germany Recruiting
Rhythm Heart Institute Vadodara Gujarat Recruiting
Lisie Hospital Kochi Kerala Recruiting
Seth GS Medical College & KEM Hospital Mumbai Maharashtra Recruiting
Arneja Heart & Multispeciality Hospital Nagpur Maharashtra Recruiting
Arneja Heart & Multispeciality Hospital Nagpur Maharashtra Not Yet Recruiting
G B Pant Institute of Postgraduate Medical Education and Research New Delhi National Capital Territory of Delhi Recruiting
VMMC & Safdarjung Hospital New Dehli New Delhi Recruiting
Dayanand Medical College & Hospital Ludhiana Punjab Recruiting
Shri Mahant Indiresh Hospital Dehradun Uttarakhand Recruiting
Sir Ganga Ram Hospital-Cardiology New Delhi India Recruiting
Sir Ganga Ram Hospital-Cardiology New Delhi India Not Yet Recruiting
NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine Bunkyo-ku, Tokyo Japan Recruiting
JA Shizuoka Kohseiren Enshu Hospital_ Cardiology Hamamatsu-shi, Shizuoka Japan Not Yet Recruiting
Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology Himeji-shi, Hyogo Japan Recruiting
National Hospital Organization Mito Medical Center_Cardiovascular medicine Ibaraki Japan Recruiting
Yokohama City University Medical Center_Cardiovascular Center Kanagawa Japan Recruiting
Yokohama City University Medical Center_Cardiovascular Center Kanagawa Japan Not Yet Recruiting

+ 52 more sites — see the full list on the official registry below.

More Novo Nordisk A/S trials in India

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 NCT06979375 on ClinicalTrials.gov ↗ ← All trials in India