RecruitingPhase 2NCT06979362

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

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

Sponsor

Novo Nordisk A/S

Enrollment

200 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure

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

Min Age: 40 YearsMax Age: 84 Years

Plain Language Summary

Simplified for easier understanding

This study is testing different doses of a new drug called CDR132L — an RNA-based therapy — in people with heart failure with preserved ejection fraction (HFpEF), a condition where the heart pumps normally but is too stiff, causing fluid buildup and breathlessness. The goal is to see whether CDR132L can improve heart structure and function. **You may be eligible if...** - You are between 40 and 84 years old - You have been diagnosed with symptomatic heart failure for at least 90 days - Your heart's pumping fraction is 50% or higher (preserved) - You have evidence of an enlarged or thickened heart muscle on echocardiogram - You are on stable, optimized heart failure medications - Your NT-proBNP (a blood marker of heart stress) is 300 or above **You may NOT be eligible if...** - You have severe kidney disease (eGFR below 30) - You have recently had a heart attack or major cardiac event - You have severely reduced pumping function or other specific heart structural problems - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCDR132L

CDR132L will be administered intravenously once every 4 weeks.

DRUGPlacebo

Placebo will be administered intravenously once every 4 weeks.

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

View Full Details on ClinicalTrials.gov

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NCT06979362

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