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Heart FailurePhase 28282-ReducedNCT06979375

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

A Phase 2 study testing CDR132L in people with Heart Failure, run by Novo Nordisk A/S at 92 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 84 years
Conditions the study is for
Heart Failure
What is being tested?
CDR132L
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
92 sitesin 10 countries
Study dates
30 Jun 2025to 23 Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

92 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

92 sites in 10 countries

Japan13 sites, 12 recruiting

  • NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine

    Bunkyo-ku, Tokyo, 113-8603

    Recruiting

  • JA Shizuoka Kohseiren Enshu Hospital_ Cardiology

    Hamamatsu-shi, Shizuoka, 430-0929

    Not yet recruiting

  • Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology

    Himeji-shi, Hyogo, 670-8560

    Recruiting

  • National Hospital Organization Mito Medical Center_Cardiovascular medicine

    Ibaraki, 311-3193

    Recruiting

  • Yokohama City University Medical Center_Cardiovascular Center

    Kanagawa, 232-0024

    Recruiting

  • Yokohama City University Medical Center_Cardiovascular Center

    Kanagawa, 232-0024

    Not yet recruiting

  • Kagawa University Hospital_Cardiology

    Kita-gun, Kagawa, 761-0793

    Completed

  • Kobe City Medical Center General Hospital_Cardiology

    Kobe-shi, Hyogo, 650-0047

    Recruiting

  • The University of Osaka Hospital_Cardiovascular medicine

    Osaka, 565-0871

    Recruiting

  • Medical Research Institute KITANO HOSPITAL_Cardiovascular Medicine

    Osaka-shi, Osaka, 530-8480

    Recruiting

  • Osaka Metropolitan University Hospital_Cardiovascular Medicine

    Osaka-Shi, Osaka, 545-8586

    Recruiting

  • Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology

    Sapporo-shi, Hokkaido, 060-8543

    Recruiting

  • National Hospital Organization Yokohama Medical Center_Cardiology

    Yokohama-shi, Kanagawa, 245-8575

    Recruiting

Other trials in Japan

Spain13 sites, 11 recruiting

  • Hospital del Mar

    Barcelona, 08003

    Recruiting

  • Hospital de Dénia_Cardiología

    Denia, 03700

    Completed

  • Hospital Univ. Virgen de la Arrixaca

    El Palmar, Murcia, 30120

    Recruiting

  • Hospital Virgen de la Arrixaca

    El Palmar, 30120

    Not yet recruiting

  • Hospital Univ. de Gerona Doctor Josep Trueta

    Girona, Catalonia, 17007

    Recruiting

  • Hospital Universitario San Cecilio

    Granada, Andalusia, 18016

    Recruiting

  • Hospital Univ. de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria, 35010

    Not yet recruiting

  • Hospital Ramón y Cajal_Cardiología

    Madrid, 28034

    Not yet recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

    Not yet recruiting

  • H. Clinico Univ. Virgen de la Victoria

    Málaga, 29010

    Completed

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

    Not yet recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

    Recruiting

Other trials in Spain

India11 sites, 11 recruiting

  • Shri Mahant Indiresh Hospital

    Dehradun, Uttarakhand, 248001

    Recruiting

  • Lisie Hospital

    Kochi, Kerala, 682018

    Recruiting

  • Dayanand Medical College & Hospital

    Ludhiana, Punjab, 141001

    Recruiting

  • Seth GS Medical College & KEM Hospital

    Mumbai, Maharashtra, 400012

    Recruiting

  • Arneja Heart & Multispeciality Hospital

    Nagpur, Maharashtra, 440010

    Recruiting

  • Arneja Heart & Multispeciality Hospital

    Nagpur, Maharashtra, 440010

    Not yet recruiting

  • VMMC & Safdarjung Hospital

    New Dehli, New Delhi, 110029

    Recruiting

  • G B Pant Institute of Postgraduate Medical Education and Research

    New Delhi, National Capital Territory of Delhi, 110002

    Recruiting

  • Sir Ganga Ram Hospital-Cardiology

    New Delhi, 110060

    Recruiting

  • Sir Ganga Ram Hospital-Cardiology

    New Delhi, 110060

    Not yet recruiting

  • Rhythm Heart Institute

    Vadodara, Gujarat, 390022

    Recruiting

Other trials in India

Poland11 sites, 11 recruiting

  • Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej

    Biała Podlaska, 21-500

    Not yet recruiting

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie Voivodeship, 15-276

    Not yet recruiting

  • American Heart of Poland S.A.

    Bielsko-Biala, 43-316

    Not yet recruiting

  • Krakowski Szpital Specjalistyczny im. Jana Pawla II

    Krakow, 31-202

    Recruiting

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

    Krakow, 31-826

    Recruiting

  • 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

    Lublin, Lublin Voivodeship, 20-049

    Not yet recruiting

  • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

    Lublin, 20-090

    Recruiting

  • Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu

    Przemyśl, 37-700

    Recruiting

  • Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

    Warsaw, 04-628

    Not yet recruiting

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

    Wroclaw, Lower Silesian Voivodeship, 50-981

    Recruiting

  • Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu

    Wroclaw, 50-556

    Recruiting

Other trials in Poland

Germany10 sites, 9 recruiting

  • Sana Kliniken Berlin-Brandenburg GmbH - Lichtenberg

    Berlin, 10365

    Completed

  • Charité - Campus Benjamin Franklin - Klinik für Kardiologie

    Berlin, 12203

    Not yet recruiting

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

    Berlin, 13353

    Recruiting

  • Uniklinik TU Dresden - Herzzentrum Dresden GmbH

    Dresden, 01307

    Recruiting

  • Universitaetsklinikum Essen - Klinik für Kardiologie und Angiologie

    Essen, 45147

    Not yet recruiting

  • Universitätsklinikum Frankfurt aM - Kardiologie

    Frankfurt am Main, 60596

    Recruiting

  • Universitätsklinikum Halle - Innere Medizin III

    Halle, 06120

    Recruiting

  • Medizinische Hochschule Hannover - Kardiologie und Angiologie

    Hanover, 30625

    Recruiting

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

    Heidelberg, 69120

    Recruiting

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

    Kiel, 24105

    Recruiting

Other trials in Germany

South Korea8 sites, 7 recruiting

  • Chungbuk National University Hospital

    Cheongju-si, 28644

    Recruiting

  • Keimyung University Dongsan Hospital

    Daegu, 42601

    Recruiting

  • Wonju Severance Christian Hospital

    Gangwon-do, 26426

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Completed

  • Korea University Anam Hospital

    Seoul, 02841

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Korea University Guro Hospital

    Seoul, 08308

    Recruiting

  • Korea University Guro Hospital

    Seoul, 08308

    Not yet recruiting

Other trials in South Korea

United Kingdom8 sites, 8 recruiting

  • Trialmed - Midlands

    Birmingham, B15 2SQ

    Recruiting

  • Wycombe General Hospital

    High Wycombe, HP11 2TT

    Recruiting

  • St Bartholomew's Hospital - Cardiac Research Office

    London, EC1A 7BE

    Not yet recruiting

  • St Bartholomew's Hospital - Cardiology

    London, EC1A 7BE

    Not yet recruiting

  • Kings College Hospital

    London, SE5 9RS

    Recruiting

  • The Royal Brompton Hospital - Respiratory CRF

    London, SW3 6HP

    Not yet recruiting

  • The James Cook University Hospital - Cardiology

    Middlesbrough, TS4 3BW

    Recruiting

  • Southampton General Hospital

    Southampton, SO16 6YD

    Recruiting

Other trials in United Kingdom

Australia7 sites, 7 recruiting

  • Royal Adelaide Hospital - Cardiology Department

    Adelaide, South Australia, 5000

    Recruiting

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

    Recruiting

  • The Prince Charles Hospital

    Brisbane, Queensland, 4032

    Not yet recruiting

  • Victorian Heart Hospital

    Clayton, Victoria, 3168

    Recruiting

  • Concord Repatriation General Hospital - Cardiology Department

    Concord, New South Wales, 2139

    Recruiting

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

    Recruiting

  • Fiona Stanley Hospital - Cardiology

    Murdoch, Western Australia, 6150

    Recruiting

Other trials in Australia

Czechia6 sites, 5 recruiting

  • Fakultní nemocnice u sv. Anny v Brně

    Brno, 602 00

    Completed

  • Nemocnice České Budějovice a.s.

    České Budějovice, 370 01

    Recruiting

  • Fakultní Nemocnice Ostrava

    Ostrava-Poruba, 708 52

    Recruiting

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

    Recruiting

  • Pratia Prague, s.r.o

    Prague, 130 00

    Not yet recruiting

  • IKEM

    Prague, 140 21

    Recruiting

Other trials in Czechia

Netherlands5 sites, 5 recruiting

  • AmsterdamUMC AMC

    Amsterdam, 1105 AZ

    Recruiting

  • Zuyderland ziekenhuis - Cardiologie

    Heerlen, 6419 PC

    Recruiting

  • Radboudumc

    Nijmegen, 6525 GA

    Recruiting

  • Erasmus MC

    Rotterdam, 3015 GD

    Recruiting

  • VieCuri - Cardiologie

    Venlo, 5912 BL

    Recruiting

Other trials in Netherlands

About this study

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 Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy

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
Being tested
CDR132L, Placebo
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CDR132LDrug

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

  • PlaceboDrug

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

Study groups in NCT06979375
Study groupRoleWhat they receive
CDR132L + SoCExperimentalParticipants 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.
Receives: Drug: CDR132L
Placebo + SoCPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Main Phase: Change in normalised microRNA-132-3p (miR-132)

    Ratio to baseline

    Measured: From baseline to week 24

Secondary outcomes (3)

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

    The composite Z-score is calculated as the mean of the participant's 3 Z-scores for the change in the 3 outcome measures: Left ventricular end-diastolic volume indexed to body surface area (LVEDVi); Left ventricular end-systolic volume indexed to body surface area (LVESVi); N-terminal pro B-type natriuretic peptide (NT-proBNP)

    Measured: From baseline to week 24

  2. Main Phase: Number of adverse events

    Count

    Measured: From baseline to week 24

  3. Extension Phase: Number of adverse events

    Count

    Measured: From baseline to week 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2025
  2. Study start30 Jun 2025
  3. Primary completion16 May 2027 (estimated)
  4. Study completion23 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06979375
Sponsor's protocol ID
NN6706-8282
Other IDs
U1111-1313-4591, 2024-515797-27, jRCT2031250305
Acronym
8282-Reduced
Status last verified
Mar 2026
First submitted
15 May 2025
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CDR132L in people with Heart Failure, run by Novo Nordisk A/S at 92 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in Japan, Spain, India, Poland, Germany and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Main Phase: Change in normalised microRNA-132-3p (miR-132) (time frame: From baseline to week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06979375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

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