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Heart FailurePhase 28212-PreservedNCT06979362

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

A Phase 2 study testing CDR132L in people with Heart Failure, run by Novo Nordisk A/S at 118 sites in 9 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
118 sitesin 9 countries
Study dates
27 Jun 2025to 25 Jul 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 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/or a sodium-glucose cotransporter-2 inhibitor (SGLT2i), 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 ≥40% 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
Show all 10Show fewer
  • 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 18.5-45 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

118 sites in 9 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

118 sites in 9 countries

United States29 sites, 25 recruiting

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

    Completed

  • Amarillo Medical Specialists

    Amarillo, Texas, 79124

    Recruiting

  • Univ of Colorado at Denver

    Aurora, Colorado, 80045

    Not yet recruiting

  • Univ of Alabama Birmingham

    Birmingham, Alabama, 35233

    Recruiting

  • Capital Area Research LLC

    Camp Hill, Pennsylvania, 17011

    Recruiting

  • Valley Clinical Trials

    Covina, California, 91723

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-8830

    Recruiting

  • Texama Medical Center

    Denison, Texas, 75020

    Not yet recruiting

  • Henry Ford Hospital_Detroit

    Detroit, Michigan, 48202

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Recruiting

  • Inova Heart and Vascular Institute

    Falls Church, Virginia, 22042

    Recruiting

  • East Texas Cardiology PA

    Houston, Texas, 77002

    Recruiting

  • UCSD NAFLD Research Center

    La Jolla, California, 92037

    Recruiting

  • UofL Health Care Outpatient

    Louisville, Kentucky, 40202

    Not yet recruiting

  • Inpatient Research Clinic LLC

    Miami Lakes, Florida, 33014

    Recruiting

  • University of Minnesota_Minneapolis_1

    Minneapolis, Minnesota, 55455

    Completed

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Recruiting

  • Icahn Sch of Med-Mt Sinai Hosp

    New York, New York, 10029

    Not yet recruiting

  • Sentara Bayside Hospital

    Norfolk, Virginia, 23507-1904

    Completed

  • Valley Clinical Trials

    Northridge, California, 91325

    Recruiting

  • AdventHealth Orlando

    Orlando, Florida, 32803

    Not yet recruiting

  • Providence St. Vincent Heart

    Portland, Oregon, 97225

    Completed

  • University of California, San Francisco

    San Francisco, California, 94110

    Recruiting

  • University of California San Francisco UCSF

    San Francisco, California, 94143

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Recruiting

  • Harbor-UCLA Medical Center

    Torrance, California, 90502

    Recruiting

  • TMC Hlthcr Clin Res Office

    Tucson, Arizona, 85712

    Not yet recruiting

  • Pima Heart and Vascular

    Tucson, Arizona, 85741

    Not yet recruiting

  • Guardian Research Org LLC

    Winter Park, Florida, 32792

    Not yet recruiting

Other trials in United States

India15 sites, 15 recruiting

  • Apollo Hospital Chennai

    Chennai, Tamil Nadu, 600006

    Recruiting

  • Apollo Hospital Chennai

    Chennai, Tamil Nadu, 600006

    Not yet recruiting

  • Shri Mahant Indiresh Hospital

    Dehradun, Uttarakhand, 248001

    Recruiting

  • Osmania General Hospital

    Hyderabad, Telangana, 500012

    Recruiting

  • Osmania General Hospital

    Hyderabad, Telangana, 500012

    Not yet recruiting

  • IPGME&R and SSKM Hospital

    Kolkata, West Bengal, 700020

    Recruiting

  • Sengupta Hospital and Research Institute

    Nagpur, Maharashtra, 440033

    Recruiting

  • All India Institute of Medical Sciences (AIIMS), Nagpur

    Nagpur, Maharashtra, 441108

    Recruiting

  • All India Institute of Medical Sciences (AIIMS), Nagpur

    Nagpur, Maharashtra, 441108

    Not yet recruiting

  • VMMC & Safdarjung Hospital

    New Dehli, New Delhi, 110029

    Recruiting

  • VMMC & Safdarjung Hospital

    New Dehli, New Delhi, 110029

    Not yet recruiting

  • G B Pant Institute of Postgraduate Medical Education and Research

    New Delhi, National Capital Territory of Delhi, 110022

    Recruiting

  • Sir Ganga Ram Hospital-Cardiology

    New Delhi, 110060

    Recruiting

  • Rhythm Heart Institute - A unit of Synergy Lifecare Pvt

    Vadodara, Gujarat, 390022

    Recruiting

  • Government Siddhartha Medical College & Government General Hospital, Vijayawada

    Vijayawada, NTR District, Andhra Pradesh, 520008

    Recruiting

Other trials in India

Japan14 sites, 13 recruiting

  • NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine

    Bunkyo-ku, Tokyo, 113-8603

    Recruiting

  • Fukuokaken Saiseikai Futsukaichi Hospital_Cardiology

    Chikushino-shi, Fukuoka, 818-8516

    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

  • Mitoyo General Hospital_Cardiovascular medicine

    Kagawa, 769-1695

    Not yet 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

  • Ome medical center_Cardiology

    Ome-shi, Tokyo, 198-0042

    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

Poland14 sites, 12 recruiting

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie Voivodeship, 15-276

    Recruiting

  • American Heart of Poland S.A.

    Bielsko-Biala, 43-316

    Recruiting

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

    Krakow, 30-688

    Recruiting

  • Krakowski Szpital Specjalistyczny im. Jana Pawla II

    Krakow, 31-202

    Completed

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

    Krakow, 31-826

    Recruiting

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338

    Recruiting

  • 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

    Lublin, Lublin Voivodeship, 20-049

    Recruiting

  • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

    Lublin, 20-090

    Recruiting

  • Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu

    Przemyśl, 37-700

    Recruiting

  • Pomorski Uniwersytet Medyczny

    Szczecin, West Pomeranian Voivodeship, 71-252

    Not yet recruiting

  • Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

    Warsaw, 04-628

    Completed

  • 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

  • Slaskie Centrum Chorob Serca W Zabrzu

    Zabrze, 41-800

    Not yet recruiting

Other trials in Poland

Canada12 sites, 10 recruiting

  • William Osler Hel Bra Civic Hs

    Brampton, Ontario, L6R 3J7

    Not yet recruiting

  • Hamilton Hlth Sc. - General Site

    Hamilton, Ontario, L8L 2X2

    Not yet recruiting

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 5G4

    Completed

  • Premier Clinical Trial Research Network (PCTRN)

    Hamilton, Ontario, L8L 5G4

    Not yet recruiting

  • Cardio Health Clinical Trials

    Hamilton, Ontario, L8W 3K5

    Not yet recruiting

  • Cardio Health Clinical Trials

    Mississauga, Ontario, L5M 2S6

    Recruiting

  • University of Ottawa Heart Institute (UOHI)

    Ottawa, Ontario, K1Y 4W7

    Recruiting

  • IUCPQ - Universite Laval

    Québec, G1V 4G5

    Recruiting

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

    Not yet recruiting

  • Women's College Hospital

    Toronto, Ontario, M5S 1B1

    Not yet recruiting

  • St Pauls Hospital

    Vancouver, British Columbia, V6Z1Y6

    Completed

  • Winchester Dist Memorial Hosp

    Winchester, Ontario, K0C 2K0

    Recruiting

Other trials in Canada

Germany10 sites, 9 recruiting

  • Sana Kliniken Berlin-Brandenburg GmbH - Lichtenberg

    Berlin, 10365

    Completed

  • Charité - Campus Benjamin Franklin - Klinik für Kardiologie

    Berlin, 12203

    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, 5 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

  • Kyunghee University Medical Center

    Seoul, 02447

    Not yet recruiting

  • Korea University Anam Hospital

    Seoul, 02841

    Recruiting

  • Korea University Guro Hospital

    Seoul, 08308

    Completed

  • Korea University Guro Hospital

    Seoul, 08308

    Withdrawn

Other trials in South Korea

Spain8 sites, 8 recruiting

  • Hospital del Mar

    Barcelona, 08003

    Recruiting

  • Hospital Univ. Virgen de la Arrixaca

    El Palmar, Murcia, 30120

    Recruiting

  • Hospital Universitario San Cecilio

    Granada, Andalusia, 18016

    Recruiting

  • Hosp. U Gran Canaria Dr. Negrín_Cardiologia

    Las Palmas de Gran Canaria, 35010

    Recruiting

  • Hospital Univ. La Luz_Cardiología

    Madrid, 28003

    Not yet recruiting

  • Hospital Ramón y Cajal_Cardiología

    Madrid, 28034

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

    Recruiting

Other trials in Spain

United Kingdom8 sites, 8 recruiting

  • Trialmed - Midlands

    Birmingham, B16 8QQ

    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

    Recruiting

  • King's College Hospital

    London, SE5 9RS

    Recruiting

  • The Royal Brompton Hospital - Respiratory CRF

    London, SW3 6HP

    Recruiting

  • The James Cook University Hospital - Cardiology

    Middlesbrough, TS4 3BW

    Recruiting

  • Southampton General Hospital

    Southampton, SO16 6YD

    Recruiting

Other trials in United Kingdom

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 Preserved 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

    CDR132L will be administered intravenously once every 4 weeks.

  • PlaceboDrug

    Placebo will be administered intravenously once every 4 weeks.

Study groups in NCT06979362
Study groupRoleWhat they receive
CDR132L: Dose 1ExperimentalParticipants 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.
Receives: Drug: CDR132L
CDR132L: Dose 2ExperimentalParticipants will receive intravenous infusion of CDR132L dose 2 once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed SoC therapy for heart failure.
Receives: Drug: CDR132L
CDR132L: Dose 3ExperimentalParticipants will receive intravenous infusion of CDR132L dose 3 once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed SoC therapy for heart failure.
Receives: Drug: CDR132L
PlaceboPlacebo comparatorParticipants will receive intravenous infusion of placebo once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed 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)

    Measured as ratio to baseline.

    Measured: From baseline to week 24

Secondary outcomes (4)

  1. Main phase: Composite Z-score based on changes in the 3 outcome measures LVMi (CMR), LAVi (CMR) and 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 mass indexed to body surface area [LVMi (Cardiovascular Magnetic Resonance [CMR])], left atrial volume indexed to body surface area [LAVi (CMR)] and N-terminal pro B-type natriuretic peptide (NT-proBNP).

    Measured: From baseline to week 24

  2. Main phase: Change in normalised miR-132

    Measured as ratio to baseline.

    Measured: From baseline to week 24

  3. Main phase: Number of adverse events

    Measured as count of events.

    Measured: From baseline to week 24

  4. Extension phase: Number of adverse events

    Measured as count of events.

    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 start27 Jun 2025
  3. Primary completion16 Nov 2027 (estimated)
  4. Study completion25 Jul 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
NCT06979362
Sponsor's protocol ID
NN6706-8212
Other IDs
U1111-1313-3984, 2024-515796-35, jRCT2031250304
Acronym
8212-Preserved
Status last verified
Sep 2026
First submitted
16 May 2025
Last updated
5 Oct 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 118 sites in 9 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 11 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, India, Japan, Poland, Canada and 4 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 NCT06979362.

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 5 Oct 2026.

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