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

NCT06979362 | Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: NN6706-8212U1111-1313-39842024-515796-35jRCT2031250304
• Study Type: interventional
• Target: 200
• Locations: 9 countries
• Sites: 109

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Main phase: Change in normalised microRNA-132-3p (miR-132)

  Measured as ratio to baseline.

  From baseline to week 24

Secondary Outcomes (4)

• Main phase: Change in composite Z-score based on the 3 outcome measures LVMi (CMR), LAVi (CMR) and NT-proBNP

  From baseline to week 24

• Main phase: Change in normalised miR-132

  From baseline to week 24

• Main phase: Number of adverse events

  From baseline to week 24

• Extension phase: Number of adverse events

  From baseline to week 60

Study Arms (4)

CDR132L: Dose 1

EXPERIMENTAL

Participants will receive intravenous infusion of CDR132L dose 1 once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure.

Drug: CDR132L

CDR132L: Dose 2

EXPERIMENTAL

Participants will receive intravenous infusion of CDR132L dose 2 once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure.

Drug: CDR132L

CDR132L: Dose 3

EXPERIMENTAL

Participants will receive intravenous infusion of CDR132L dose 3 once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure.

Drug: CDR132L

Placebo

PLACEBO COMPARATOR

Participants will receive intravenous infusion of placebo once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure.

Drug: Placebo

Interventions

CDR132L DRUG

CDR132L will be administered intravenously once every 4 weeks.

CDR132L: Dose 1; CDR132L: Dose 2; CDR132L: Dose 3

Placebo DRUG

Placebo will be administered intravenously once every 4 weeks.

Placebo

Eligibility Criteria

• Age: 40 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• LVMi \>95 g/m2 for female participants and \>115 g/m2 for male participants using the linear method (cube formula).
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (109)

Univ of Alabama Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

TMC Hlthcr Clin Res Office

Tucson, Arizona, 85712, United States

NOT YET RECRUITING

Pima Heart and Vascular

Tucson, Arizona, 85741, United States

NOT YET RECRUITING

Valley Clinical Trials

Covina, California, 91723, United States

RECRUITING

UCSD NAFLD Research Center

La Jolla, California, 92037, United States

NOT YET RECRUITING

Valley Clinical Trials

Northridge, California, 91325, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94110, United States

NOT YET RECRUITING

University of California San Francisco UCSF

San Francisco, California, 94143, United States

RECRUITING

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

NOT YET RECRUITING

CPC Clinical Research & Community Health

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Inpatient Research Clinic LLC

Miami Lakes, Florida, 33014, United States

RECRUITING

AdventHealth Orlando

Orlando, Florida, 32803, United States

NOT YET RECRUITING

Guardian Research Org LLC

Winter Park, Florida, 32792, United States

NOT YET RECRUITING

UofL Health Care Outpatient

Louisville, Kentucky, 40202, United States

NOT YET RECRUITING

Henry Ford Hospital_Detroit

Detroit, Michigan, 48202, United States

RECRUITING

University of Minnesota_Minneapolis_1

Minneapolis, Minnesota, 55455, United States

COMPLETED

Washington University School of Medicine

St Louis, Missouri, 63110, United States

NOT YET RECRUITING

Icahn Sch of Med-Mt Sinai Hosp

New York, New York, 10029, United States

NOT YET RECRUITING

Duke University

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

Providence St. Vincent Heart

Portland, Oregon, 97225, United States

COMPLETED

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

COMPLETED

Capital Area Research LLC

Camp Hill, Pennsylvania, 17011, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

NOT YET RECRUITING

Amarillo Medical Specialists

Amarillo, Texas, 79124, United States

NOT YET RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9302, United States

RECRUITING

Texama Medical Center

Denison, Texas, 75020, United States

NOT YET RECRUITING

East Texas Cardiology PA

Houston, Texas, 77002, United States

RECRUITING

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

NOT YET RECRUITING

Sentara Bayside Hospital

Norfolk, Virginia, 23507-1904, United States

COMPLETED

St Pauls Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

COMPLETED

William Osler Hel Bra Civic Hs

Brampton, Ontario, L6R 3J7, Canada

NOT YET RECRUITING

Hamilton Hlth Sc. - General Site

Hamilton, Ontario, L8L 2X2, Canada

NOT YET RECRUITING

Hamilton General Hospital

Hamilton, Ontario, L8L 5G4, Canada

COMPLETED

Cardio Health Clinical Trials

Hamilton, Ontario, L8W 3K5, Canada

NOT YET RECRUITING

Cardio Health Clinical Trials

Mississauga, Ontario, L5M 2S6, Canada

RECRUITING

University of Ottawa Heart Ins

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

NOT YET RECRUITING

Women's College Hospital

Toronto, Ontario, M5S 1B1, Canada

NOT YET RECRUITING

Winchester Dist Memorial Hosp

Winchester, Ontario, K0C 2K0, Canada

RECRUITING

Unv de Cardiologie et dePneum

Québec, G1V 4G5, Canada

NOT YET RECRUITING

Sana Kliniken Berlin-Brandenburg GmbH - Lichtenberg

Berlin, 10365, Germany

COMPLETED

Charité - Campus Benjamin Franklin - Klinik für Kardiologie

Berlin, 12203, Germany

NOT YET RECRUITING

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

Berlin, 13353, Germany

RECRUITING

Uniklinik TU Dresden - Herzzentrum Dresden GmbH

Dresden, 01307, Germany

RECRUITING

Universitaetsklinikum Essen - Klinik für Kardiologie und Angiologie

Essen, 45147, Germany

NOT YET RECRUITING

Universitätsklinikum Frankfurt aM - Kardiologie

Frankfurt am Main, 60596, Germany

RECRUITING

Universitätsklinikum Halle - Innere Medizin III

Halle, 06120, Germany

RECRUITING

Medizinische Hochschule Hannover - Kardiologie und Angiologie

Hanover, 30625, Germany

RECRUITING

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

Heidelberg, 69120, Germany

RECRUITING

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

Kiel, 24105, Germany

RECRUITING

Rhythm Heart Institute - A unit of Synergy Lifecare Pvt

Vadodara, Gujarat, 390022, India

RECRUITING

Sengupta Hospital and Research Institute

Nagpur, Maharashtra, 440033, India

RECRUITING

All India Institute of Medical Sciences (AIIMS), Nagpur

Nagpur, Maharashtra, 441108, India

RECRUITING

All India Institute of Medical Sciences (AIIMS), Nagpur

Nagpur, Maharashtra, 441108, India

NOT YET RECRUITING

G B Pant Institute of Postgraduate Medical Education and Research

New Delhi, National Capital Territory of Delhi, 110022, India

RECRUITING

VMMC & Safdarjung Hospital

New Dehli, New Delhi, 110029, India

RECRUITING

VMMC & Safdarjung Hospital

New Dehli, New Delhi, 110029, India

NOT YET RECRUITING

Apollo Hospital Chennai

Chennai, Tamil Nadu, 600006, India

RECRUITING

Apollo Hospital Chennai

Chennai, Tamil Nadu, 600006, India

NOT YET RECRUITING

Osmania General Hospital

Hyderabad, Telangana, 500012, India

RECRUITING

Osmania General Hospital

Hyderabad, Telangana, 500012, India

NOT YET RECRUITING

Shri Mahant Indiresh Hospital

Dehradun, Uttarakhand, 248001, India

RECRUITING

IPGME&R and SSKM Hospital

Kolkata, West Bengal, 700020, India

RECRUITING

Sir Ganga Ram Hospital-Cardiology

New Delhi, 110060, India

RECRUITING

NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine

Bunkyo-ku, Tokyo, 113-8603, Japan

RECRUITING

Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology

Himeji-shi, Hyogo, 670-8560, Japan

RECRUITING

National Hospital Organization Mito Medical Center_Cardiovascular medicine

Ibaraki, 311-3193, Japan

RECRUITING

Yokohama City University Medical Center_Cardiovascular Center

Kanagawa, 232-0024, Japan

RECRUITING

Yokohama City University Medical Center_Cardiovascular Center

Kanagawa, 232-0024, Japan

NOT YET RECRUITING

Kagawa University Hospital_Cardiology

Kita-gun, Kagawa, 761-0793, Japan

COMPLETED

Kobe City Medical Center General Hospital_Cardiology

Kobe-shi, Hyogo, 650-0047, Japan

RECRUITING

Medical Research Institute KITANO HOSPITAL_Cardiovascular Medicine

Osaka-shi, Osaka, 530-8480, Japan

RECRUITING

Osaka Metropolitan University Hospital_Cardiovascular Medicine

Osaka-Shi, Osaka, 545-8586, Japan

RECRUITING

Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology

Sapporo-shi, Hokkaido, 060-8543, Japan

RECRUITING

National Hospital Organization Yokohama Medical Center_Cardiology

Yokohama-shi, Kanagawa, 245-8575, Japan

RECRUITING

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

Wroclaw, Lower Silesian Voivodeship, 50-981, Poland

RECRUITING

1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

Lublin, Lublin Voivodeship, 20-049, Poland

NOT YET RECRUITING

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Podlaskie Voivodeship, 15-276, Poland

NOT YET RECRUITING

American Heart of Poland S.A.

Bielsko-Biala, 43-316, Poland

NOT YET RECRUITING

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

NOT YET RECRUITING

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, 31-202, Poland

RECRUITING

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

Krakow, 31-826, Poland

RECRUITING

Instytut Centrum Zdrowia Matki Polki

Lodz, 93-338, Poland

NOT YET RECRUITING

Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

Lublin, 20-090, Poland

RECRUITING

Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu

Przemyśl, 37-700, Poland

RECRUITING

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Warsaw, 04-628, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu

Wroclaw, 50-556, Poland

RECRUITING

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

RECRUITING

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

RECRUITING

Wonju Severance Christian Hospital

Gangwon-do, 26426, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

COMPLETED

Korea University Anam Hospital

Seoul, 02841, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 08308, South Korea

COMPLETED

Korea University Guro Hospital

Seoul, 08308, South Korea

WITHDRAWN

Hospital Universitario San Cecilio

Granada, Andalusia, 18016, Spain

RECRUITING

Hospital Univ. Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Hosp. U Gran Canaria Dr. Negrín_Cardiologia

Las Palmas de Gran Canaria, 35010, Spain

NOT YET RECRUITING

Hospital Ramón y Cajal_Cardiología

Madrid, 28034, Spain

NOT YET RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Trialmed - Midlands

Birmingham, B15 2SQ, United Kingdom

RECRUITING

Wycombe General Hospital

High Wycombe, HP11 2TT, United Kingdom

NOT YET RECRUITING

St Bartholomew's Hospital - Cardiac Research Office

London, EC1A 7BE, United Kingdom

NOT YET RECRUITING

St Bartholomew's Hospital - Cardiology

London, EC1A 7BE, United Kingdom

NOT YET RECRUITING

Kings College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

The Royal Brompton Hospital - Respiratory CRF

London, SW3 6HP, United Kingdom

NOT YET RECRUITING

The James Cook University Hospital - Cardiology

Middlesbrough, TS4 3BW, United Kingdom

RECRUITING

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 19, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): May 16, 2027
• Study Completion (Estimated): January 23, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

JP (11); KR (7); US (29); IN (14); CA (11); DE (10); ES (7); GB (8); PL (12)