A Research Study Comparing CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy

NCT06979375 | Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: NN6706-8282U1111-1313-45912024-515797-27jRCT2031250305
• Study Type: interventional
• Target: 200
• Locations: 10 countries
• Sites: 92

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)

  Ratio to baseline

  From baseline to week 24

Secondary Outcomes (3)

• Main Phase: Change in composite Z-score based on the 3 outcome measures: LVEDVi; LVESVi; NT-proBNP

  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 (2)

CDR132L + SoC

EXPERIMENTAL

Participants will receive intravenous infusion of CDR132L 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 + SoC

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

Administered intravenous infusion of CDR132L once every 4 weeks for 48 weeks.

CDR132L + SoC

Placebo DRUG

Administered intravenous infusion of placebo once every 4 weeks for 48 weeks.

Placebo + SoC

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 heart failure (HF) diagnosed greater than or equal to (≥) 180 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 optimized doses and unchanged drug classes of guideline-directed HF therapy ≥ 45 days prior to randomisation.
• Left ventricular ejection fraction (LVEF) less than (\<) 50 percent (%) as assessed by echocardiography at screening, measured by central laboratory.
• Left ventricular hypertrophy or left ventricular dilatation assessed by echocardiography at screening measured by central laboratory with any of the following:
• LVMi greater than (\>)88 g/m\^2 for female participants and \>102 g/m\^2 for male participants using the truncated ellipsoid method.
• LVMi \>95 g/m\^2 for female participants and \>115 g/m\^2 for male participants, using the linear method (cube formula).
• Left ventricular end-diastolic diameter indexed to body surface area (LVEDDi) \>3.1 cm/m\^2 for female participants and \>3.0 cm/m\^2 for male participants.
• Body mass index 18.5-40 kilogram per meter square (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).
• N-terminal pro B-type natriuretic peptide (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 (eGFR) less than (\<) 30 milliliter/minute/ 1.73-meter square (mL/min/1.73 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 hospitalization within 30 days prior to screening.
• Participants receiving intravenous HF medications within 45 days prior to randomisation.
• Planned coronary revascularization, pacemaker/cardioverter-defibrillator/cardiac resynchronization therapy (CRT) implantation, ablation of cardiac arrythmias or 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 greater than (\>) 2.5x 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 (92)

Concord Repatriation General Hospital - Cardiology Department

Concord, New South Wales, 2139, Australia

RECRUITING

The Prince Charles Hospital

Brisbane, Queensland, 4032, Australia

NOT YET RECRUITING

Royal Adelaide Hospital - Cardiology Department

Adelaide, South Australia, 5000, Australia

RECRUITING

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

RECRUITING

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

RECRUITING

Victorian Heart Hospital

Clayton, Victoria, 3168, Australia

RECRUITING

Fiona Stanley Hospital - Cardiology

Murdoch, Western Australia, 6150, Australia

RECRUITING

Fakultní nemocnice u sv. Anny v Brně

Brno, 602 00, Czechia

COMPLETED

Nemocnice České Budějovice a.s.

České Budějovice, 370 01, Czechia

RECRUITING

Fakultní Nemocnice Ostrava

Ostrava-Poruba, 708 52, Czechia

RECRUITING

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

RECRUITING

Pratia Prague, s.r.o

Prague, 130 00, Czechia

NOT YET RECRUITING

IKEM

Prague, 140 21, Czechia

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

Vadodara, Gujarat, 390022, India

RECRUITING

Lisie Hospital

Kochi, Kerala, 682018, India

RECRUITING

Seth GS Medical College & KEM Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

Arneja Heart & Multispeciality Hospital

Nagpur, Maharashtra, 440010, India

RECRUITING

Arneja Heart & Multispeciality Hospital

Nagpur, Maharashtra, 440010, India

NOT YET RECRUITING

G B Pant Institute of Postgraduate Medical Education and Research

New Delhi, National Capital Territory of Delhi, 110002, India

RECRUITING

VMMC & Safdarjung Hospital

New Dehli, New Delhi, 110029, India

RECRUITING

Dayanand Medical College & Hospital

Ludhiana, Punjab, 141001, India

RECRUITING

Shri Mahant Indiresh Hospital

Dehradun, Uttarakhand, 248001, India

RECRUITING

Sir Ganga Ram Hospital-Cardiology

New Delhi, 110060, India

RECRUITING

Sir Ganga Ram Hospital-Cardiology

New Delhi, 110060, India

NOT YET RECRUITING

NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine

Bunkyo-ku, Tokyo, 113-8603, Japan

RECRUITING

JA Shizuoka Kohseiren Enshu Hospital_ Cardiology

Hamamatsu-shi, Shizuoka, 430-0929, Japan

NOT YET 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

The University of Osaka Hospital_Cardiovascular medicine

Osaka, 565-0871, 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

AmsterdamUMC AMC

Amsterdam, 1105 AZ, Netherlands

RECRUITING

Zuyderland ziekenhuis - Cardiologie

Heerlen, 6419 PC, Netherlands

RECRUITING

Radboudumc

Nijmegen, 6525 GA, Netherlands

RECRUITING

Erasmus MC

Rotterdam, 3015 GD, Netherlands

RECRUITING

VieCuri - Cardiologie

Venlo, 5912 BL, Netherlands

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

Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej

Biała Podlaska, 21-500, Poland

NOT YET RECRUITING

American Heart of Poland S.A.

Bielsko-Biala, 43-316, 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

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

NOT YET 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

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 08308, South Korea

NOT YET RECRUITING

Hospital Universitario San Cecilio

Granada, Andalusia, 18016, Spain

RECRUITING

Hospital Univ. de Gerona Doctor Josep Trueta

Girona, Catalonia, 17007, Spain

RECRUITING

Hospital Univ. Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Hospital de Dénia_Cardiología

Denia, 03700, Spain

COMPLETED

Hospital Virgen de la Arrixaca

El Palmar, 30120, Spain

NOT YET RECRUITING

Hospital Univ. de Gran Canaria Doctor Negrín

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 Universitario Puerta de Hierro Majadahonda

Majadahonda, 28222, Spain

NOT YET RECRUITING

H. Clinico Univ. Virgen de la Victoria

Málaga, 29010, Spain

COMPLETED

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

NOT YET 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

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

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 19, 2025
• Study Start: June 30, 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

CZ (6); KR (8); ES (13); PL (11); AU (7); JP (13); DE (10); NL (5); IN (11); GB (8)