Clinical trial NCT06979375: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Heart Failure
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2025-05-19
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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 ≥ 30 days prior to randomization.
* Left ventricular ejection fraction (LVEF) less than (\<) 50 percent (%) as assessed by echocardiography at screening, measured by central laboratory.
* Left ventricular mass indexed to body surface area (LVMi) greater than (\>) 88 gram per meter square (g/m\^2) for female participants and \>102 g/m\^2 for male participants as assessed by echocardiography at screening, using the truncated ellipsoid method measured by central laboratory.
* Left atrial volume indexed to body surface area (LAVi) ≥ 29 milliliter per meter square (mL/m\^2) as assessed by echocardiography at screening, measured by central laboratory.
* 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 randomization.
* Myocardial infarction, unstable angina pectoris or HF hospitalization within 30 days prior to screening.
* Participants receiving intravenous HF medications within 30 days prior to randomization.
* Planned coronary revascularization, pacemaker/cardioverter-defibrillator/cardiac resynchronization therapy (CRT) implantation, ablation of cardiac arrythmias or valve repair/replacement at the time of randomization.
* Stroke or transient ischemic attack within 12 months prior to randomization.
* 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 cause of increased cardiac mass (including likely pathogenic variants within dilated cardiomyopathy, hypertrophic cardiomyopathy and Fabry disease).
* Participants with suspected or diagnosed cardiac amyloidosis or sarcoidosis.

Primary outcomes:
measure: Main Phase: Change in microRNA-132-3p (miR-132)
timeFrame: From baseline to week 24
Secondary outcomes:
measure: Main Phase: Change in composite Z-score based on the 3 outcome measures: LVEDVi; LVESVi; NT-proBNP
timeFrame: From baseline to week 24
measure: Main Phase: Number of adverse events
timeFrame: From baseline to week 24
measure: Extension Phase: Number of adverse events
timeFrame: From baseline to week 60
Other outcomes:
Locations:
city: Concord
country: Australia
facility: Concord Repatriation General Hospital - Cardiology
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital Cardiovascular Clinical Trials
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Clayton
country: Australia
facility: Victorian Heart Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital Cardiology
state: Western Australia
city: Brno
country: Czechia
facility: Fakultní nemocnice u sv. Anny v Brně
city: Ceske Budejovice
country: Czechia
facility: Nemocnice České Budějovice a.s.
city: Ostrava-Poruba
country: Czechia
facility: Fakultní Nemocnice Ostrava
city: Praha 4
country: Czechia
facility: IKEM
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Berlin
country: Germany
facility: Sana Klinikum Berlin-Brandenburg-Lichtenberg - Innere Medizin II
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
city: Essen
country: Germany
facility: Universitaetsklinikum Essen - Klinik für Kardiologie und Angiologie
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt aM - Kardiologie
city: Halle (Saale)
country: Germany
facility: Universitätsklinikum Halle - Innere Medizin III
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie
city: Heidelberg
country: Germany
facility: Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein - Medizinischen Klinik III Kardiologie und Internistische Intensivmedizin
city: New Delhi
country: India
facility: G B Pant Institute of Postgraduate Medical Education and Research
state: Delhi
city: Vadodara
country: India
facility: Rhythm Heart Institute
state: Gujarat
city: Kochi
country: India
facility: Lisie Hospital
state: Kerala
city: Mumbai
country: India
facility: Seth GS Medical College & KEM Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Arneja Heart & Multispeciality Hospital
state: Maharashtra
city: New Dehli
country: India
facility: VMMC & Safdarjung Hospital
state: New Delhi
city: Ludhiana
country: India
facility: Dayanand Medical College & Hospital
state: Punjab
city: Dehradun
country: India
facility: Shri Mahant Indiresh Hospital
state: Uttarakhand
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital-Cardiology
city: Bunkyo-ku, Tokyo
country: Japan
facility: NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine
city: Himeji-shi, Hyogo
country: Japan
facility: Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology
city: Ibaraki
country: Japan
facility: National Hospital Organization Mito Medical Center_Cardiovascular medicine
city: Kanagawa
country: Japan
facility: Yokohama City University Medical Center_Cardiovascular Center
city: Kita-gun, Kagawa
country: Japan
facility: Kagawa University Hospital_Cardiology
city: Kobe-shi, Hyogo
country: Japan
facility: Kobe City Medical Center General Hospital_Cardiology
city: Osaka-shi, Osaka
country: Japan
facility: Medical Research Institute KITANO HOSPITAL_Cardiovascular Medicine
city: Osaka-Shi, Osaka
country: Japan
facility: Osaka Metropolitan University Hospital_Cardiovascular Medicine
city: Osaka
country: Japan
facility: Osaka University Hospital_Cardiovascular medicine
city: Sapporo-shi, Hokkaido
country: Japan
facility: Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology
city: Yokohama-shi, Kanagawa
country: Japan
facility: National Hospital Organization Yokohama Medical Center_Cardiology
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Gangwon-do
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Heerlen
country: Netherlands
facility: Zuyderland ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Venlo
country: Netherlands
facility: VieCuri
city: Wroclaw
country: Poland
facility: 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
state: Dolnoslaskie
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
state: Podlaskie
city: Biala Podlaska
country: Poland
facility: Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
city: Bielsko-Biała
country: Poland
facility: American Heart of Poland S.A.
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II
city: Kraków
country: Poland
facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.
city: Lublin
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
city: Warsaw
country: Poland
facility: Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
state: Andalucía
city: Girona
country: Spain
facility: Hospital Universitario de Gerona Doctor Josep Trueta
state: Cataluña
city: El Palmar
country: Spain
facility: Hospital Virgen de la Arrixaca
state: Murcia
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Dénia
country: Spain
facility: Hospital de Dénia
city: El Palmar
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Clínico Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: High Wycombe
country: United Kingdom
facility: Wycombe General Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: The Royal Brompton Hospital - Cardiovascular Research Centre/Respiratory CRF
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: