Clinical trial NCT06979362: 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
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 Preserved 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 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 New York Heart Association class II-III at screening
* Clinically stable and on optimised doses and unchanged drug classes of guideline-directed HF therapy ≥30 days prior to randomisation
* Left ventricular ejection fraction ≥50% as assessed by echocardiography at screening, measured by central laboratory
* LVMi (greater than) \>88 gram per square meter (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
* LAVi ≥29 milliliter per square meter (mL/m\^2) as assessed by echocardiography at screening, measured by central laboratory
* Body mass index 18.5-40 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 30 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 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 LVMi (CMR), LAVi (CMR) and NT-proBNP
timeFrame: From baseline to week 24
measure: Main phase: Change in miR-132
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: Birmingham
country: United States
facility: Univ of Alabama Birmingham
state: Alabama
city: Tucson
country: United States
facility: Pima Heart and Vascular
state: Arizona
city: Covina
country: United States
facility: Valley Clinical Trials
state: California
city: La Jolla
country: United States
facility: UCSD NAFLD Research Center
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: San Francisco
country: United States
facility: University of California San Francisco UCSF
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Aurora
country: United States
facility: CPC Clinical Research & Community Health
state: Colorado
city: Miami Lakes
country: United States
facility: Inpatient Research Clinic LLC
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Louisville
country: United States
facility: UofL Health Care Outpatient
state: Kentucky
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota_Minneapolis_1
state: Minnesota
city: New York
country: United States
facility: Icahn Sch of Med-Mt Sinai Hosp
state: New York
city: Durham
country: United States
facility: Duke University_Durham
state: North Carolina
city: Portland
country: United States
facility: Providence St. Vincent Heart
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Camp Hill
country: United States
facility: Capital Area Research LLC
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Heart Clinical Research Institute
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: East Texas Cardiology PA
state: Texas
city: Falls Church
country: United States
facility: Inova Heart and Vascular Institute
state: Virginia
city: Norfolk
country: United States
facility: Sentara Bayside Hospital
state: Virginia
city: Vancouver
country: Canada
facility: St Pauls Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Hlth Sc. - General Site
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Mississauga
country: Canada
facility: Cardio Health Clinical Trials
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Ins
state: Ontario
city: Toronto
country: Canada
facility: Toronto Heart Centre THC St. Michael's Heart Centre
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
city: Winchester
country: Canada
facility: Winchester Dist Memorial Hosp
state: Ontario
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 - A unit of Synergy Lifecare Pvt
state: Gujarat
city: Nagpur
country: India
facility: Sengupta Hospital and Research Institute
state: Maharashtra
city: Nagpur
country: India
facility: All India Institute of Medical Sciences (AIIMS), Nagpur
state: Maharashtra
city: New Dehli
country: India
facility: VMMC & Safdarjung Hospital
state: New Delhi
city: Chennai
country: India
facility: Apollo Hospital Chennai
state: Tamil Nadu
city: Hyderabad
country: India
facility: Osmania General Hospital
state: Telangana
city: Kolkata
country: India
facility: IPGME&R and SSKM Hospital
state: West Bengal
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: 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: Korea University Guro Hospital
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: 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: El Palmar
country: Spain
facility: Hospital Virgen de la Arrixaca
state: Murcia
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
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: