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NCT06979362PHASE2Recruiting

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

Novo Nordisk A/S

Start Date

6/27/2025

Completion Date

7/25/2028

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

Age Range: 40 years to 84 years

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 ≥45 days prior to randomisation * Left ventricular ejection fraction ≥50% 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: 1. 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 2. LVMi \>95 g/m2 for female participants and \>115 g/m2 for male participants using the linear method (cube formula). 3. 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 18.5-40 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 45 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 (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.

Interventions

DRUG

CDR132L

DRUG

Placebo

Interested in This Trial?

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Conditions

Heart Failure

Locations

Univ of Alabama Birmingham

Birmingham, Alabama 35233

United States

TMC Hlthcr Clin Res Office

Tucson, Arizona 85712

United States

Pima Heart and Vascular

Tucson, Arizona 85741

United States

Valley Clinical Trials

Covina, California 91723

United States

UCSD NAFLD Research Center

La Jolla, California 92037

United States

Valley Clinical Trials

Northridge, California 91325

United States

University of California, San Francisco

San Francisco, California 94110

United States

University of California San Francisco UCSF

San Francisco, California 94143

United States

Harbor-UCLA Medical Center

Torrance, California 90502

United States

Univ of Colorado at Denver

Aurora, Colorado 80045

United States

Inpatient Research Clinic LLC

Miami Lakes, Florida 33014

United States

AdventHealth Orlando

Orlando, Florida 32803

United States

Guardian Research Org LLC

Winter Park, Florida 32792

United States

UofL Health Care Outpatient

Louisville, Kentucky 40202

United States

Henry Ford Hospital_Detroit

Detroit, Michigan 48202

United States

University of Minnesota_Minneapolis_1

Minneapolis, Minnesota 55455

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Icahn Sch of Med-Mt Sinai Hosp

New York, New York 10029

United States

Duke University

Durham, North Carolina 27710

United States

Providence St. Vincent Heart

Portland, Oregon 97225

United States

Abington Memorial Hospital

Abington, Pennsylvania 19001

United States

Capital Area Research LLC

Camp Hill, Pennsylvania 17011

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Amarillo Medical Specialists

Amarillo, Texas 79124

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390-9302

United States

Texama Medical Center

Denison, Texas 75020

United States

East Texas Cardiology PA

Houston, Texas 77002

United States

Inova Heart and Vascular Institute

Falls Church, Virginia 22042

United States

Sentara Bayside Hospital

Norfolk, Virginia 23507-1904

United States

St Pauls Hospital

Vancouver, British Columbia V6Z1Y6

Canada

William Osler Hel Bra Civic Hs

Brampton, Ontario L6R 3J7

Canada

Hamilton Hlth Sc. - General Site

Hamilton, Ontario L8L 2X2

Canada

Hamilton General Hospital

Hamilton, Ontario L8L 5G4

Canada

Premier Clinical Trial Research Network (PCTRN)

Hamilton, Ontario L8L 5G4

Canada

Cardio Health Clinical Trials

Hamilton, Ontario L8W 3K5

Canada

Cardio Health Clinical Trials

Mississauga, Ontario L5M 2S6

Canada

University of Ottawa Heart Institute (UOHI)

Ottawa, Ontario K1Y 4W7

Canada

St. Michael's Hospital

Toronto, Ontario M5B 1W8

Canada

Women's College Hospital

Toronto, Ontario M5S 1B1

Canada

Winchester Dist Memorial Hosp

Winchester, Ontario K0C 2K0

Canada

IUCPQ - Universite Laval

Québec, G1V 4G5

Canada

Sana Kliniken Berlin-Brandenburg GmbH - Lichtenberg

Berlin, 10365

Germany

Charité - Campus Benjamin Franklin - Klinik für Kardiologie

Berlin, 12203

Germany

Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU)

Berlin, 13353

Germany

Uniklinik TU Dresden - Herzzentrum Dresden GmbH

Dresden, 01307

Germany

Universitaetsklinikum Essen - Klinik für Kardiologie und Angiologie

Essen, 45147

Germany

Universitätsklinikum Frankfurt aM - Kardiologie

Frankfurt am Main, 60596

Germany

Universitätsklinikum Halle - Innere Medizin III

Halle, 06120

Germany

Medizinische Hochschule Hannover - Kardiologie und Angiologie

Hanover, 30625

Germany

UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie

Heidelberg, 69120

Germany

Uniklinik Schleswig-Holstein - Med. Klinik III Kardiologie und Internist. Intensivmedizin

Kiel, 24105

Germany

Rhythm Heart Institute - A unit of Synergy Lifecare Pvt

Vadodara, Gujarat 390022

India

Sengupta Hospital and Research Institute

Nagpur, Maharashtra 440033

India

All India Institute of Medical Sciences (AIIMS), Nagpur

Nagpur, Maharashtra 441108

India

All India Institute of Medical Sciences (AIIMS), Nagpur

Nagpur, Maharashtra 441108

India

G B Pant Institute of Postgraduate Medical Education and Research

New Delhi, National Capital Territory of Delhi 110022

India

VMMC & Safdarjung Hospital

New Dehli, New Delhi 110029

India

VMMC & Safdarjung Hospital

New Dehli, New Delhi 110029

India

Government Siddhartha Medical College & Government General Hospital, Vijayawada

Vijayawada, NTR District, Andhra Pradesh 520008

India

Apollo Hospital Chennai

Chennai, Tamil Nadu 600006

India

Apollo Hospital Chennai

Chennai, Tamil Nadu 600006

India

Osmania General Hospital

Hyderabad, Telangana 500012

India

Osmania General Hospital

Hyderabad, Telangana 500012

India

Shri Mahant Indiresh Hospital

Dehradun, Uttarakhand 248001

India

IPGME&R and SSKM Hospital

Kolkata, West Bengal 700020

India

Sir Ganga Ram Hospital-Cardiology

New Delhi, 110060

India

NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine

Bunkyo-ku, Tokyo, 113-8603

Japan

Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology

Himeji-shi, Hyogo, 670-8560

Japan

National Hospital Organization Mito Medical Center_Cardiovascular medicine

Ibaraki, 311-3193

Japan

Mitoyo General Hospital_Cardiovascular medicine

Kagawa, 769-1695

Japan

Yokohama City University Medical Center_Cardiovascular Center

Kanagawa, 232-0024

Japan

Yokohama City University Medical Center_Cardiovascular Center

Kanagawa, 232-0024

Japan

Kagawa University Hospital_Cardiology

Kita-gun, Kagawa, 761-0793

Japan

Kobe City Medical Center General Hospital_Cardiology

Kobe-shi, Hyogo, 650-0047

Japan

Ome medical center_Cardiology

Ome-shi, Tokyo, 198-0042

Japan

Medical Research Institute KITANO HOSPITAL_Cardiovascular Medicine

Osaka-shi, Osaka, 530-8480

Japan

Osaka Metropolitan University Hospital_Cardiovascular Medicine

Osaka-Shi, Osaka, 545-8586

Japan

Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology

Sapporo-shi, Hokkaido, 060-8543

Japan

National Hospital Organization Yokohama Medical Center_Cardiology

Yokohama-shi, Kanagawa, 245-8575

Japan

4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu

Wroclaw, Lower Silesian Voivodeship 50-981

Poland

1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

Lublin, Lublin Voivodeship 20-049

Poland

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Podlaskie Voivodeship 15-276

Poland

Pomorski Uniwersytet Medyczny

Szczecin, West Pomeranian Voivodeship 71-252

Poland

American Heart of Poland S.A.

Bielsko-Biala, 43-316

Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, 30-688

Poland

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, 31-202

Poland

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

Krakow, 31-826

Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, 93-338

Poland

Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

Lublin, 20-090

Poland

Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu

Przemyśl, 37-700

Poland

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Warsaw, 04-628

Poland

Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu

Wroclaw, 50-556

Poland

Slaskie Centrum Chorob Serca W Zabrzu

Zabrze, 41-800

Poland

Chungbuk National University Hospital

Cheongju-si, 28644

South Korea

Keimyung University Dongsan Hospital

Daegu, 42601

South Korea

Wonju Severance Christian Hospital

Gangwon-do, 26426

South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620

South Korea

Korea University Anam Hospital

Seoul, 02841

South Korea

Korea University Guro Hospital

Seoul, 08308

South Korea

Korea University Guro Hospital

Seoul, 08308

South Korea

Hospital Universitario San Cecilio

Granada, Andalusia 18016

Spain

Hospital Univ. Virgen de la Arrixaca

El Palmar, Murcia 30120

Spain

Hospital del Mar

Barcelona, 08003

Spain

Hosp. U Gran Canaria Dr. Negrín_Cardiologia

Las Palmas de Gran Canaria, 35010

Spain

Hospital Ramón y Cajal_Cardiología

Madrid, 28034

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Clinico Universitario de Valencia

Valencia, 46010

Spain

Trialmed - Midlands

Birmingham, B16 8QQ

United Kingdom

Wycombe General Hospital

High Wycombe, HP11 2TT

United Kingdom

St Bartholomew's Hospital - Cardiac Research Office

London, EC1A 7BE

United Kingdom

St Bartholomew's Hospital - Cardiology

London, EC1A 7BE

United Kingdom

King's College Hospital

London, SE5 9RS

United Kingdom

The Royal Brompton Hospital - Respiratory CRF

London, SW3 6HP

United Kingdom

The James Cook University Hospital - Cardiology

Middlesbrough, TS4 3BW

United Kingdom

Southampton General Hospital

Southampton, SO16 6YD

United Kingdom