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RECRUITING

NCT06979362

PHASE2

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

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 Preserved Ejection Fraction and Left Ventricular Hypertrophy

Key Details

Gender

All

Age Range

40 Years - 84 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-06-27

Completion Date

2028-01-23

Last Updated

2026-03-11

Healthy Volunteers

Conditions

Heart Failure

Interventions

DRUG

CDR132L

CDR132L will be administered intravenously once every 4 weeks.

DRUG

Placebo

Placebo will be administered intravenously once every 4 weeks.

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.

Locations (109)

Univ of Alabama Birmingham

Birmingham, Alabama, United States

TMC Hlthcr Clin Res Office

Tucson, Arizona, United States

Pima Heart and Vascular

Tucson, Arizona, United States

Valley Clinical Trials

Covina, California, United States

UCSD NAFLD Research Center

La Jolla, California, United States

Valley Clinical Trials

Northridge, California, United States

University of California, San Francisco

San Francisco, California, United States

University of California San Francisco UCSF

San Francisco, California, United States

Harbor-UCLA Medical Center

Torrance, California, United States

CPC Clinical Research & Community Health

Aurora, Colorado, United States

Inpatient Research Clinic LLC

Miami Lakes, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Guardian Research Org LLC

Winter Park, Florida, United States

UofL Health Care Outpatient

Louisville, Kentucky, United States

Henry Ford Hospital_Detroit

Detroit, Michigan, United States

University of Minnesota_Minneapolis_1

Minneapolis, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Icahn Sch of Med-Mt Sinai Hosp

New York, New York, United States

Duke University

Durham, North Carolina, United States

Providence St. Vincent Heart

Portland, Oregon, United States

Abington Memorial Hospital

Abington, Pennsylvania, United States

Capital Area Research LLC

Camp Hill, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Amarillo Medical Specialists

Amarillo, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Texama Medical Center

Denison, Texas, United States

East Texas Cardiology PA

Houston, Texas, United States

Inova Heart and Vascular Institute

Falls Church, Virginia, United States

Sentara Bayside Hospital

Norfolk, Virginia, United States

St Pauls Hospital

Vancouver, British Columbia, Canada

William Osler Hel Bra Civic Hs

Brampton, Ontario, Canada

Hamilton Hlth Sc. - General Site

Hamilton, Ontario, Canada

Hamilton General Hospital

Hamilton, Ontario, Canada

Cardio Health Clinical Trials

Hamilton, Ontario, Canada

Cardio Health Clinical Trials

Mississauga, Ontario, Canada

University of Ottawa Heart Ins

Ottawa, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Women's College Hospital

Toronto, Ontario, Canada

Winchester Dist Memorial Hosp

Winchester, Ontario, Canada

Unv de Cardiologie et dePneum

Québec, Canada

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 - A unit of Synergy Lifecare Pvt

Vadodara, Gujarat, India

Sengupta Hospital and Research Institute

Nagpur, Maharashtra, India

All India Institute of Medical Sciences (AIIMS), Nagpur

Nagpur, Maharashtra, India

All India Institute of Medical Sciences (AIIMS), Nagpur

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

VMMC & Safdarjung Hospital

New Dehli, New Delhi, India

Apollo Hospital Chennai

Chennai, Tamil Nadu, India

Apollo Hospital Chennai

Chennai, Tamil Nadu, India

Osmania General Hospital

Hyderabad, Telangana, India

Osmania General Hospital

Hyderabad, Telangana, India

Shri Mahant Indiresh Hospital

Dehradun, Uttarakhand, India

IPGME&R and SSKM Hospital

Kolkata, West Bengal, India

Sir Ganga Ram Hospital-Cardiology

New Delhi, India

NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine

Bunkyo-ku, Tokyo, 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

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

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

American Heart of Poland S.A.

Bielsko-Biala, Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, Poland

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, Poland

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

Krakow, Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, 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

Korea University Guro Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Hospital Universitario San Cecilio

Granada, Andalusia, Spain

Hospital Univ. Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital del Mar

Barcelona, Spain

Hosp. U Gran Canaria Dr. Negrín_Cardiologia

Las Palmas de Gran Canaria, Spain

Hospital Ramón y Cajal_Cardiología

Madrid, Spain

Hospital Universitario La Paz

Madrid, 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 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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (109)