AzTrials
AzTrials

Transthyretin Amyloid Cardiomyopathy (ATTR CM)Phase 3CLEOPATTRANCT07207811

CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis

A Phase 3 study testing NNC6019-0001 in people with Transthyretin Amyloid Cardiomyopathy (ATTR CM), run by Novo Nordisk A/S at 299 sites in 20 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 find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NNC6019-0001
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,280 participants
Where
299 sitesin 20 countries
Study dates
2 Oct 2025to 29 Jun 2029
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female.
  • Age 18 years or above at the time of signing the informed consent.
  • Have an established diagnosis of ATTR-CM (wild-type ATTR [ATTRwt] or variant ATTR [ATTRv]), with cardiac amyloid infiltration, increased left ventricular (LV) wall thickness, and HF.
  • Note: Target ATTRv recruitment is approximately 15 percent of the study population.
  • Cardiac amyloid infiltration demonstrated by: i. Cardiac biopsy positive for TTR amyloid, OR ii. Grade 2 or 3 cardiac uptake at pyrophosphate (PYP)/diphosphono-1,2-propanodicarboxylic acid (DPD)/ hydroxymethylene diphosphonate (HMDP) nuclear medicine imaging with single-photon emission computed tomography (SPECT) or SPECT/CT (preferably) combined with an extracardiac biopsy positive for TTR amyloid, OR iii. Grade 2 or 3 cardiac uptake at PYP/DPD/HMDP nuclear medicine imaging with SPECT or SPECT/CT (preferably) combined with normal serum free light chain ratio, and negative serum and urine protein electrophoresis with immunofixation (SPIE \& UPIE)/or mass spectrometry based methods including mass fixation).
  • Notes:
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  • Non-invasive diagnostic pathway will be confirmed by a centralised expert review.
  • Bone tracer nuclear medicine imaging with SPECT or SPECT/CT (preferably) will be conducted using 99m-technetium (Tc)-labelled pyrophosphate (99mTc-PYP), 99mTc-labelled 3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc-DPD), or 99mTc-labeled hydroxymethylene diphosphonate (99mTc-HMDP).
  • The eGFR adjusted acceptable serum free light chain ratio.
  • Patients with Grade 2 or 3 cardiac uptake at PYP/DPD/HDMP nuclear imaging with SPECT or SPECT/CT (preferably) and evidence of monoclonal gammopathy of undetermined significance (MGUS; based on serum and urine protein electrophoresis and serum free light chains) will require endomyocardial biopsy with typing using mass spectrometry or immunohistochemistry to confirm presence of TTR protein in tissue.
  • Timing of serum free light chain ratio, SPIE, UPIE and mass spectrometry-based methods including mass fixation should be within 12 months of SPECT or SPECT/CT nuclear imaging.
  • Increased LV wall thickness, as assessed by centralised review of echocardiography, showing interventricular septal wall thickness greater than or equal to 12 millimeter (mm).
  • Chronic HF (New York Heart Association [NYHA] Class I-IV): i. At least 1 documented hospitalisation for HF, OR ii. History of HF manifested by signs or symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath, signs of pulmonary congestion on x-ray or auscultation, or peripheral oedema that required or requires ongoing treatment with a diuretic).
  • Expected to be on stable cardiovascular medical therapy (defined as no greater than 50 percent dose adjustment and no categorical changes of medications), with the exception of diuretics, 4 weeks prior to the randomisation visit.
  • Completed more than 50 meters on the 6MWT at screening.

Who cannot join

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Current or previous participation (dosing with active treatment) in a study for an investigational ATTR depleting drug or ATTR gene editing therapy.
  • Total bilirubin greater than 3 times the upper limit of normal (ULN) at screening.
  • Current diagnosis or history of amyloid light chain, other non-ATTR amyloidosis, known leptomeningeal amyloidosis, or multiple myeloma.
  • HF not primarily caused by ATTR-CM (e.g., due to hypertension, valvular heart disease, or ischemic heart disease in the opinion of the investigator).
  • Currently hospitalised or hospitalised within 14 days prior to screening.
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  • Currently treated with positive inotropic medication.
  • Uncorrected, severe, haemodynamically significant, left-sided heart valve disease.
  • Acute coronary syndrome, unstable angina, stroke, transient ischemic attack, coronary revascularisation, cardiac device implantation, cardiac valve repair, or major surgery within 60 days of screening.
  • Prior solid organ transplant or planned solid organ transplant during the study.
  • Left ventricular ejection fraction (LVEF) less than 30 percent as assessed by centralised review of echocardiography.
  • Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, carcinoma in situ/high-grade prostatic intraepithelial neoplasia [PIN], low-risk prostate cancer, or on stable therapy for prostate cancer) within 3 years before screening.
  • End-stage renal disease (estimated glomerular filtration rate [eGFR] less than 15 mL/min/1.73 m^2 at screening, or chronic/intermittent haemodialysis or peritoneal dialysis).

Trial locations and contacts

299 sites in 20 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

299 sites in 20 countries

United States63 sites, 62 recruiting

  • Jefferson Health

    Abington, Pennsylvania, 19001

    Recruiting

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

    Recruiting

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

    Recruiting

  • Ascension Texas Cardiovascular Research Institute

    Austin, Texas, 78705

    Recruiting

  • St. Davids Heart and Vascular

    Austin, Texas, 78751

    Recruiting

  • University of Maryland Medical Center (UMMC) - Children's Hospital (UMCH)

    Baltimore, Maryland, 21201

    Recruiting

  • John Hopkins Medicine

    Baltimore, Maryland, 21287

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Northwestern University Clinical and Translational Sciences Institute

    Chicago, Illinois, 60611

    Recruiting

  • The University of Chicago Medicine

    Chicago, Illinois, 60637

    Recruiting

  • The Carl and Edyth Lindner-Center for Research and Education at The Christ Hospital

    Cincinnati, Ohio, 45219-2906

    Recruiting

  • Cleveland Clinic - Taussig Cancer Institute

    Cleveland, Ohio, 44195

    Recruiting

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio, 43214

    Recruiting

  • Baylor Scott & White Research Institute - Annette C. and Harold C. Simmons Transplant Institute

    Dallas, Texas, 75246

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-9045

    Recruiting

  • Henry Ford Health

    Detroit, Michigan, 48202

    Recruiting

  • Duke University Health System

    Durham, North Carolina, 27750

    Recruiting

  • Inova Fairfax Hospital - Inova Heart and Vascular Institute

    Falls Church, Virginia, 22042

    Recruiting

  • Profound Research

    Farmington Hills, Michigan, 48334

    Recruiting

  • UF Health Heart and Vascular Hospital

    Gainesville, Florida, 32608

    Recruiting

  • Northeast Georgia Heart Center, Pc (Nghc)

    Gainesville, Georgia, 30501-3466

    Recruiting

  • Endeavor Health - Glenbrook Hospital

    Glenview, Illinois, 60026

    Recruiting

  • Prisma Health

    Greenville, South Carolina, 29605

    Recruiting

  • Penn State Milton S.Hershey Medical Center - Penn State Hershey Cancer Institute

    Hershey, Pennsylvania, 17033

    Not yet recruiting

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813

    Recruiting

  • Baylor St. Luke Medical Center

    Houston, Texas, 77030

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Recruiting

  • Indiana University (IU) Health - Methodist Professional Center II

    Indianapolis, Indiana, 46202

    Recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

    Recruiting

  • University of California San Diego (UCSD) - Sulpizio Cardiovascular Center (SCVC)

    La Jolla, California, 92037

    Recruiting

  • The Heart Group of Lancaster General Health

    Lancaster, Pennsylvania, 17603

    Recruiting

  • Keck School of Medicine USC - Healthcare Consultation Center 2 (HCCII)

    Los Angeles, California, 90033

    Recruiting

  • Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute

    Los Angeles, California, 90048

    Not yet recruiting

  • North Shore University Hospital, Northwell Health

    Manhasset, New York, 11030

    Recruiting

  • Intermountain Healthcare - Intermountain Medical Center - C. DuWayne Schmidt Chest Clinic

    Murray, Utah, 84107

    Recruiting

  • Saint Thomas Health

    Nashville, Tennessee, 37205

    Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

    Recruiting

  • LCMC - LSU University Medical Center New Orleans LCMC Center

    New Orleans, Louisiana, 70112

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Recruiting

  • Weill Medical College Of Cornell University

    New York, New York, 10021

    Recruiting

  • Mount Sinai Medical Center

    New York, New York, 10029

    Recruiting

  • Columbia University Medical Center

    New York, New York, 10032

    Recruiting

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia, 23507

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Recruiting

  • UCI Medical Center

    Orange, California, 92868

    Recruiting

  • Profound Research LLC at Southern California Heart Specialists

    Pasadena, California, 91105

    Recruiting

  • Penn Medicine: University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Mayo Clinic in Arizona

    Phoenix, Arizona, 85054

    Recruiting

  • Baylor Scott & White The Heart Hospital

    Plano, Texas, 75093

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Recruiting

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Recruiting

  • Laurelton Heart Specialist, PC

    Rosedale, New York, 11422

    Recruiting

  • University of California, San Francisco Medical Center

    San Francisco, California, 94143

    Recruiting

  • NorthBay Clinical Research

    Santa Rosa, California, 95405

    Recruiting

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington, 99201

    Recruiting

  • Saint Louis University

    St Louis, Missouri, 63110

    Not yet recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Recruiting

  • Lucile Packard Children's Hospital

    Stanford, California, 94305

    Recruiting

  • Yeshiva University - Albert Einstein College of Medicine - Montefiore Medical Center (MMC)

    The Bronx, New York, 10467-2401

    Recruiting

  • Cardiology Associates Research, LLc

    Tupelo, Mississippi, 38801

    Completed

  • MedStar Heart & Vascular Institute (MHVI) - MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010-3017

    Recruiting

Other trials in United States

China33 sites, 32 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Recruiting

  • FuWai Hospital, CAMS & PUMC

    Beijing, Beijing Municipality, 100037

    Not yet recruiting

  • Beijing University Third Hospital

    Beijing, Beijing Municipality, 100191

    Recruiting

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Recruiting

  • TEDA International Cardiovascular Hospital

    Binhai, 300456

    Recruiting

  • China-Japan Union Hospital

    Changchun, Changchun, 130033

    Recruiting

  • Xiangya Hospital

    Changsha, Hunan, 410008

    Not yet recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

    Recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

    Recruiting

  • The First Affiliated Hospital Of Chongqing Medical University

    Chongqing, 400000

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

    Recruiting

  • Southern Medical University

    Guangzhou, Guangdong, 510000

    Not yet recruiting

  • Guangdong Academy of Medical Science (GAMS) - Guangdong General Hospital (GGH) - Guangdong Neuroscience Institute

    Guangzhou, Guangdong, 510080

    Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515

    Recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

    Recruiting

  • The First Affiliated Hospital, School of Medicine, ZheJiang University

    Hangzhou, Zhejiang, 310003

    Recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

    Not yet recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

    Recruiting

  • Qi-Lu Hospital of Shandong University School of Medicine

    Jinan, Shandong, 250012

    Recruiting

  • Shandong Provincial Hospital (SPH)

    Jinan, Shandong, 250021

    Recruiting

  • Jinan Central Hospital

    Jinan, 250013

    Recruiting

  • Shengjing University Of China Medical University

    Liaoning, Liaoning, 110004

    Not yet recruiting

  • The Second Affiliated Hospital Of Nanchang University

    Nanchang, 330000

    Recruiting

  • Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital)

    Nanjing, Jiangsu, 210029

    Recruiting

  • Renji Hospital

    Shanghai, Shanghai Municipality, 200127

    Terminated

  • Shanghai Jiao Tong University (SJTU) - Shanghai Chest Hospital (SCH)

    Shanghaishi, Shanghai Municipality, 200025

    Not yet recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Recruiting

  • Shanxi Medical University - First Hospital

    Taiyuan, Shanxi, 30001

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

    Recruiting

  • Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital

    Wuhan, Hubei, 430030

    Not yet recruiting

  • Wuhan University - Renmin Hospital (Hubei General Hospital)

    Wuhan, Hubei, 430060

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Not yet recruiting

Other trials in China

Italy25 sites, 24 recruiting

  • Azienda Ospedaliero Universitaria delle Marche

    Ancona - Torrette, 60126

    Not yet recruiting

  • Policlinico S.Orsola Malpighi, Universita di Bologna

    Bologna, 40138

    Recruiting

  • Azienda Sanitaria del Sudtirol-Ospedale di Bolzano

    Bolzano, 39100

    Not yet recruiting

  • Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

    Brescia, 25123

    Recruiting

  • Azienda Ospedaliera Universitaria Di Ferrara

    Cona, 44124

    Recruiting

  • Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)

    Florence, 50134

    Recruiting

  • Ospedale di Ivrea

    Ivrea, 10015

    Recruiting

  • ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco

    Lecco, 23900

    Recruiting

  • Azienda Ospedaliera Universitaria Gaetano Martino Messina

    Messina, 98124

    Recruiting

  • Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano

    Milan, 20122

    Recruiting

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

    Milan, 20132

    Recruiting

  • Centro Cardiologico Monzino IRCCS

    Milan, 20138

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

    Recruiting

  • Azienda Ospedaliera dei Colli - Ospedale Monaldi

    Naples, 80131

    Not yet recruiting

  • University of Naples Federico II

    Naples, 80131

    Recruiting

  • Ospedale S. Luigi Gonzaga

    Orbassano, 10043

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

    Recruiting

  • Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo

    Pavia, 27100

    Terminated

  • Universita degli Studi di Perugia

    Perugia, 06121

    Recruiting

  • Fondazione Toscana Gabriele Monasterio Per La Ricerca Medica E Di Sanita Pubblica (Ftgm)

    Pisa, 56126

    Recruiting

  • Policlinico Umberto I

    Roma, 161

    Not yet recruiting

  • Ospedale Sant'Andrea Hospital

    Rome, 00189

    Recruiting

  • Istituto Patologia Speciale Medica Universita Cattolica del Sacro Cuore - Policlinico Universitario Agostino Gemelli

    Rome, 186

    Recruiting

  • Irccs Policlinico Di San Donato Milanese

    San Donato Milanese, 20097

    Recruiting

  • Polo Cardiologico - Ospedale Cattinara (ASUGI)

    Trieste, 34149

    Recruiting

Other trials in Italy

Japan25 sites, 25 recruiting

  • Hyogo PrefecturalAmagasaki General Medical Center

    Amagasaki, 660-8550

    Recruiting

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo, 113-8603

    Recruiting

  • Saiseikai Fukuoka General Hospital

    Fukuoka, Fukuoka, 810-0001

    Recruiting

  • Hyogo Prefectural Harima-Himeji General Medical Center

    Himeji, Hyōgo, 670-0836

    Recruiting

  • Kitasato University - Kitasato University Hospital (KUH)

    Kanagawa, 2520375

    Recruiting

  • Nara Medical University Hospital

    Kashihara, Nara, 634-8522

    Recruiting

  • Hospital of University of Occupational and Environmental Health

    Kitakyushu, Fukuoka, 807-8556

    Recruiting

  • Kobe University Hospital

    Kobe, Hyōgo, 6500017

    Recruiting

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556

    Recruiting

  • Social Welfare Organization Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital

    Kumamoto, 861-4193

    Recruiting

  • Kurume University - Research Center for Innovative Cancer Therapy

    Kurume-shi, Fukuoka, 830-0011

    Recruiting

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

    Recruiting

  • Shinshu University Hospital, Shinshu University Graduate School Of Medicine

    Matsumoto, Nagano, 390-8621

    Recruiting

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

    Recruiting

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

    Recruiting

  • Kochi Medical School Hospital

    Nankoku-shi, Kochi, 783-8505

    Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586

    Recruiting

  • Sapporo Medical University Hospital

    Sapporo, Hokkaid, 060-8543

    Recruiting

  • National Cerebral and Cardiovascular Center

    Suita, Osaka, 564-8565

    Recruiting

  • Keio University Hospital

    Tokyo, 160-8582

    Recruiting

  • Toyama Prefectural Central Hospital

    Toyama, 930-8550

    Recruiting

  • Mie University Graduate School of Medicine

    Tsu, Mie-ken, 514-8507

    Recruiting

  • Uwajima City Hospital

    Uwajima-shi, Ehime, 798-8510

    Recruiting

  • Yamaguchi University Hospital

    Yamaguchi Prefecture, Yamaguchi, 755-8505

    Recruiting

  • Showa University Fujigaoka Hospital

    Yokohama, Kanagawa, 227-8501

    Recruiting

Other trials in Japan

Spain22 sites, 22 recruiting

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006

    Recruiting

  • Hospital Universitari Germans Trias i Pujol (HUGTP)

    Badalona, 08916

    Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

    Barcelona, 08036

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

    Recruiting

  • Hospital Universitario de Basurto

    Bilbao, 48013

    Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

    Recruiting

  • Hospital Universitario Donostia

    Donostia / San Sebastian, 20014

    Recruiting

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, 08907

    Recruiting

  • Hospital Universitario Doctor Negrin

    Las Palmas de Gran Canaria, 35010

    Not yet recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Recruiting

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, 28222

    Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

    Recruiting

  • Hospital Son Llatzer (HSLL)

    Palma de Mallorca, 07198

    Recruiting

  • Hospital Clinico Universitario De Santiago De Compostela

    Santiago de Compostela, 15706

    Recruiting

  • Universidad de Sevilla - Hospital Universitario Virgen Macarena

    Seville, 41009

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

    Recruiting

  • Servicio Andaluz de Salud (SAS) - Hospital San Juan de la Cruz

    Úbeda, 23400

    Recruiting

  • Fundacion Investigacion Clinico de Valencia (FIHCUV) - Instituto de Investigacion Sanitaria (INCLIVA)

    Valencia, 46010

    Recruiting

  • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

    Valencia, 46026

    Recruiting

  • Hospital Clinico Universitario Lozano Blesa de Zaragoza

    Zaragoza, 50009

    Recruiting

Other trials in Spain

France20 sites, 19 recruiting

  • Centre Hospitalier Universitaire d'Amiens-Picardie - Site Sud

    Amiens, 80054

    Recruiting

  • Hospices Civils de Lyon (HCL) - Hopital Louis Pradel

    Bron, 69677

    Not yet recruiting

  • Centre Hospital Regional Et Universitaire De Tours (Chru Tours) - Houpital Trousseau

    Chambray-lès-Tours, 37170

    Recruiting

  • Hospital Henri Mondor

    Créteil, 94000

    Recruiting

  • CHU De Dijon Hopital Du Bocage

    Dijon, 21079

    Recruiting

  • Centre Hospitalier Departemental Vendee (CHD) - L'Hopital de la Roche-sur-Yon (CHD Les Oudairies)

    La Roche-sur-Yon, 85925

    Recruiting

  • Centre Hospitalier Universitaire de Grenoble (CHUG) Hopital Nord

    La Tronche, 38043

    Recruiting

  • Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone

    Marseille, 13385

    Recruiting

  • Hospital Center Annecy Genevois-Centre Hospitalier de la Region d'Annecy CHRA

    Metz-Tessy, 74370

    Recruiting

  • Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve

    Montpellier, 34090

    Recruiting

  • CHU De Nantes - Hopital Laennec

    Nantes, 44093

    Recruiting

  • Centre Hospitalier Universitaire de Nice - Hopital Pasteur

    Nice, 06001

    Recruiting

  • Groupement Hospitalier Universitaire Ouest - Hopital Europeen Georges-Pompidou (HEGP)

    Paris, 75015

    Recruiting

  • Hopital Bichat - Claude-Bernard

    Paris, 75018

    Recruiting

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque

    Pessac, 33604

    Recruiting

  • Centre Hospitalier Universitaire de Poitiers la Miletrie

    Poitiers, 86021

    Recruiting

  • Centre Hospitalier Universitaire (CHU) de Rennes

    Rennes, 35000

    Recruiting

  • Centre Hospitalier de Toulon - Hopital Sainte-Musse

    Toulon, 83100

    Recruiting

  • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil

    Toulouse, 31059

    Recruiting

  • Private Hospital Medipole

    Villeurbanne, 69100

    Terminated

Other trials in France

Brazil18 sites, 17 recruiting

  • Cardresearch Cardiologia Assistencial e de Pesquisa Ltda

    Belo Horizonte, Minas Gerais, 30150-274

    Recruiting

  • NUPEC Cardio

    Belo Horizonte, Minas Gerais, 30220

    Not yet recruiting

  • Nucleo de Pesquisa Clinica NUPEC

    Belo Horizonte, 30220

    Recruiting

  • L2 IP - Instituto de Pesquisas Clinicas LTDA

    Brasília, Federal District, 70200-730

    Recruiting

  • Universidade Estadual de Campinas - UNICAMP

    Campinas, São Paulo, 13083-888

    Not yet recruiting

  • Synvia Laboratórios e Toxicologia Ltda - Synvia Clinical

    Campinas, São Paulo, 13087-567

    Recruiting

  • Universidade de Caxias do sul

    Caxias do Sul, Rio Grande do Sul, 95070560

    Recruiting

  • Pontificia Universidade Catolica do Parana (PUCPR) - Centro de Ciencias Biologicas e da Saude (CCBS)

    Curitiba, Paraná, 80230-130

    Recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

    Recruiting

  • Instituto D'Or de Pesquisa e Ensino - Recife

    Recife - PE, Recife - PE, 50070-490

    Not yet recruiting

  • Centro Avancado de Pesquisa-Estudo para-Diagnostico-CAPED

    Ribeirão Preto, São Paulo, 14026-020

    Recruiting

  • Hospital Das Clinicas Da Faculdade De Medicina De Ribeirao Preto da Universidade de Sao Paulo

    Ribeirão Preto, São Paulo, 14049-900

    Recruiting

  • Instituto D'Or de Pesquisa e Ensino - Hospital Cardio Pulmonar (HCP)

    Salvador, Estado de Bahia, 40170-130

    Terminated

  • Instituto D'Or de Pesquisa e Ensino - Hospital Cardio Pulmonar (HCP)

    Salvador, 40170-130

    Recruiting

  • Instituto de Cardiologia Dante Pazzanese

    São Paulo, 04012-180

    Recruiting

  • Pseg Centro De Pesquisa Clinica S.A

    São Paulo, 04038-002

    Recruiting

  • Universidade de Sao Paulo (USP) Hospital das Clinicas da Faculdade de Medicina (HCFMUSP)

    São Paulo, 05403-900

    Recruiting

  • Eurolatino Pesquisas Medicas Ltda - (Eurolatino Medical Research - EMR)

    Uberlândia, Minas Gerais, 38400-500

    Recruiting

Other trials in Brazil

Canada14 sites, 12 recruiting

  • University of Calgary

    Calgary, Alberta, T2N 1N4

    Not yet recruiting

  • Health Sciences North Research Institute-Advanced Medical Research Institute of Canada

    Greater Sudbury, Ontario, P3E 5J1

    Not yet recruiting

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 3A7

    Recruiting

  • Cardio Health Clinical Trials

    Hamilton, Ontario, L8W 3K5

    Recruiting

  • Cardio Health Clinical Trials

    Kitchener, N2C 1L3

    Not yet recruiting

  • London Health Sciences Centre - University Hospital

    London, Ontario, N6A 5A5

    Recruiting

  • Cardio Health Clinical Trials

    Mississauga, Ontario, L5M 2S6

    Recruiting

  • University of Ottawa - Heart Institute (UOHI) (Institut de Cardiologie de L'Universite d'Ottawa)

    Ottawa, Ontario, K1Y 4W7

    Terminated

  • CIUSSS du Saguenay Lac-Saint-Jean

    Québec, Chicoutimi, G7H 7M4

    Not yet recruiting

  • Hotel Dieu de Quebec

    Québec, G1R 2J6

    Recruiting

  • Centre Hospitalier Regional De Rimouski

    Rimouski, G5L 5T1

    Not yet recruiting

  • Cardio Health Clinical Trials

    Scarborough Village, Ontario, M1B 0A7

    Completed

  • Riverside Cardiology and Diagnostic Imaging

    Toronto, Ontario, M6N 1B5

    Recruiting

  • Vancouver General Hospital

    Vancouver, British Columbia, V6Z 1Y6

    Recruiting

Other trials in Canada

Belgium12 sites, 12 recruiting

  • AZORG Ziekenhuis

    Aalst, Oost-Vlaanderen, 9300

    Recruiting

  • Az Middelheim

    Antwerp, 2020

    Recruiting

  • Algemeen Ziekenhuis Sint-Jan

    Bruges, 8000

    Recruiting

  • Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel

    Brussels, Anderlecht, 1070

    Recruiting

  • Ziekenhuis Oost-Limburg (ZOL)

    Genk, 3600

    Recruiting

  • Universitair Ziekenhuis Brussel

    Jette, Brusselss, 1090

    Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

    Recruiting

  • Centre Hospitalier Regional CHR de la Citadelle

    Liège, 4000

    Recruiting

  • AZ Delta (H.-Hartziekenhuis Roeselare-Menen vzw (HHRM)) - Campus Wilgenstraat Roeselare

    Roeselare, 8800

    Not yet recruiting

  • Algemeen Ziekenhuis Sint-Blasius (AZSB)

    Sint-Gillis-Dendermonde, Oost-Vlaanderen, 9200

    Not yet recruiting

  • ZOL Genk, Campus Sint-Jan

    Waterschei-Zwartberg, Limburg, 3600

    Not yet recruiting

  • Clinique Universitaire de Mont Godinne

    Yvoir, 5530

    Recruiting

Other trials in Belgium

Germany12 sites, 12 recruiting

  • Universitätsklinik Der Ruhr-Universität Bochum

    Bad Oeynhausen, 32545

    Recruiting

  • Charite - Universitaetsmedizin Berlin

    Berlin, 13353

    Recruiting

  • Universitaetsklinikum Koeln

    Cologne, 50937

    Recruiting

  • Universitatsklinikum Carl Gustav Carus

    Dresden, 01307

    Recruiting

  • University Hospital Frankfurt

    Frankfurt am Main, 60590

    Not yet recruiting

  • University Heart Center Freiburg

    Freiburg im Breisgau, 79106

    Recruiting

  • Universitaetsklinikum Jena

    Jena, 07747

    Recruiting

  • Universitaetsklinikum Schleswig-Holstein

    Kiel, 24105

    Recruiting

  • Deutsches Herzzentrum Muenchen

    München, 80636

    Not yet recruiting

  • University of Munich (LMU)-Grosshadern Hospital

    Munich, 81377

    Not yet recruiting

  • Universitaetsklinikum Muenster

    Münster, 48149

    Recruiting

  • University of Wurzburg, Comprehensive Heart Failure Center (CHFC)

    Würzburg, 97078

    Recruiting

Other trials in Germany

Australia11 sites, 11 recruiting

  • Central Adelaide Local Health Network - Royal Adelaide Hospital

    Adelaide, South Australia, 5000

    Recruiting

  • Flinders Medical Centre

    Adelaide, South Australia, 5042

    Recruiting

  • Victorian Heart Hospital

    Clayton, Victoria, 03168

    Recruiting

  • ST Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

    Not yet recruiting

  • Hobart Hospital-Royal Hobart Hospital

    Hobart, Tasmania, 7000

    Recruiting

  • Joondalup Cardiovascular Trials Foundation Inc.

    Joondalup, Western Australia, 6027

    Recruiting

  • Liverpool Renal Clinical Research Centre

    Liverpool, New South Wales, 2170

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, 3004

    Recruiting

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

    Recruiting

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Recruiting

  • Metro South Health - Princess Alexandra Hospital (PAH)

    Woolloongabba, Queensland, 4102

    Recruiting

Other trials in Australia

Argentina9 sites, 9 recruiting

  • Hospital Italiano de Buenos Aires (HIBA)

    Buenos Aires, 1199ABB

    Not yet recruiting

  • Centro Medico dr Besada

    Buenos Aires, 1426

    Not yet recruiting

  • Nexo salud

    Buenos Aires, C1025ABI

    Not yet recruiting

  • Icba - Instituto Cardiovascular De Buenos Aires

    Buenos Aires, C1428ART

    Not yet recruiting

  • Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

    Caba, 1425

    Not yet recruiting

  • Hospital Privado Centro Medico de Cordoba S.A.

    Córdoba, 5016

    Not yet recruiting

  • Instituto de Cardiologia de Corrientes Juana Fca. Cabral

    Corrientes, W3400AMZ

    Not yet recruiting

  • Dim Clinica Privada

    Ramos Mejía, B1704ETD

    Not yet recruiting

  • Centro de Investigaciones Clinicas del Litoral

    Santa Fe, S3000FWO

    Not yet recruiting

Other trials in Argentina

Czechia7 sites, 7 recruiting

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 602 00

    Not yet recruiting

  • Edumed s.r.o.

    Broumov, Hradec Králové Region, 55101

    Recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

    Recruiting

  • Fakultni Nemocnice Ostrava

    Ostrava-Poruba, 708 52

    Not yet recruiting

  • Interni klinika kardiologie a angiologie 1. Lekarske fakulty a Vseobecne fakultni nemocnice v Praze

    Prague, 12808

    Not yet recruiting

  • IKEM, Kardiologicka klinika

    Prague, 140 21

    Recruiting

  • Clinical Trials Service s.r.o.

    Uherské Hradiště, 686 01

    Recruiting

Other trials in Czechia

United Kingdom7 sites, 6 recruiting

  • Synexus Scotland Clinical Research Centre

    Bellshill, Lanarkshire, ML4 3NJ

    Recruiting

  • Synexus Midlands Clinical Research Centre

    Birmingham, West Midlands, B15 2SQ

    Recruiting

  • Synexus Wales Clinical Research Centre

    Cardiff, CF15 9SS

    Recruiting

  • Synexus Merseyside Clinical Research Centre

    Liverpool, L22 0LG

    Terminated

  • The Royal Free Hospital - Royal Free London NHS Foundation Trust

    London, Greater London, NW3 2QG

    Recruiting

  • Richmond Pharmacology - MHRA Phase 1 Unit

    London, SE1 1YR

    Recruiting

  • Synexus Manchester Clinical Research Centre

    Manchester, Greater Manchester, M15 6SE

    Recruiting

Other trials in United Kingdom

South Korea6 sites, 6 recruiting

  • Inje University Haeundae Paik Hospital

    Busan, 48108

    Recruiting

  • Seoul National University Bundang Hospital (SNUBH)

    Seongnam-si, Gyeonggi-do, 13620

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

    Recruiting

Other trials in South Korea

Netherlands4 sites, 4 recruiting

  • University Medical Center Groningen

    Groningen, 9713 GZ

    Recruiting

  • Maastricht University Medical Center (MUMC)

    Maastricht, 6229 HX

    Not yet recruiting

  • Erasmus Medisch Centrum 1

    Rotterdam, South Holland, 3015 GD

    Recruiting

  • Universitair Medisch Centrum Utrecht (UMC Utrecht)

    Utrecht, 3584 CX

    Recruiting

Other trials in Netherlands

Denmark3 sites, 3 recruiting

  • Aarhus Universitetshospital Skejby

    Aarhus, Central Jutland, 8200

    Recruiting

  • Hjertecentret (The Heart Center)-Copenhagen University Hospital/Rigshosptalet

    Copenhagen, Capital Region, 2100

    Recruiting

  • Odense Universitetshospital

    Odense C, 5000

    Recruiting

Other trials in Denmark

Ireland3 sites, 3 recruiting

  • Portiuncula Hospital

    Ballinasloe, H53 T971

    Not yet recruiting

  • Trinity College Dublin (TCD) - St. James's Hospital (SJH)

    Dublin, D08 F2H7

    Not yet recruiting

  • Letterkenny University Hospital

    Letterkenny, F92 AE81

    Not yet recruiting

Other trials in Ireland

Poland3 sites, 3 recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

    Not yet recruiting

  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego

    Poznan, 61-848

    Not yet recruiting

  • Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego

    Warsaw, 04-628

    Not yet recruiting

Other trials in Poland

Sweden2 sites, 2 recruiting

  • Karolinska Universitetssjukhuset (Karolinska University Hospital)

    Huddinge, 141 86

    Not yet recruiting

  • Umea University Hospital

    Umeå, 90185

    Not yet recruiting

Other trials in Sweden

About this study

Official title: CLEOPATTRA: Effects of NNC6019-0001 Versus Placebo on Cardiovascular Outcomes in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.

Being tested
NNC6019-0001, Placebo (NNC6019-0001)

What participants receive

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

  • NNC6019-0001Drug

    NNC6019-0001 will be administered IV.

  • Placebo (NNC6019-0001)Drug

    Placebo matched to NNC6019-0001 will be administered IV.

Study groups in NCT07207811
Study groupRoleWhat they receive
NNC6019-0001ExperimentalParticipants will receive NNC6019-0001 intravenously (IV). Participants will also have the option to continue any Standard of care (SoC) treatments as recommended by their medical health professional.
Receives: Drug: NNC6019-0001
PlaceboPlacebo comparatorParticipants will receive placebo matched to NNC6019-0001 IV. Participants will also have the option to continue any SoC treatments as recommended by their medical health professional.
Receives: Drug: Placebo (NNC6019-0001)

What is being measured

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

  1. Composite Outcome of cardiovascular (CV) deaths and recurrent CV events (CV hospitalisations and urgent heart failure [HF] visits)

    Measured as count of events.

    Measured: From baseline (week 0) to end of study (EOS) (up to approximately 4 years)

Secondary outcomes (21)

  1. Change in Kansas city cardiomyopathy questionnaire- clinical summary score (KCCQ-CSS)

    Measured as score on a scale. KCCQ-CSS is a score derived from a 23-item patient-reported outcome (PRO) measure assessing health status in individuals with HF. The score ranges from 0 to 100, with higher scores indicating better health status.

    Measured: From baseline (week 0) to approximately 2 years

  2. Change in Kansas city cardiomyopathy questionnaire- overall summary score (KCCQ-OSS)

    Measured as score on a scale. KCCQ-OSS is a score derived from a 23-item PRO measure assessing health status in individuals with HF. The score ranges from 0 to 100, with higher scores indicating better health status.

    Measured: From baseline (week 0) to approximately 2 years

  3. Change in 6-minute walk distance (6MWD)

    Measured in meters.

    Measured: From baseline (week 0) to approximately 2 years

  4. Number of occurrences of CV events (CV hospitalisation and urgent HF visits)

    Measured as count of events.

    Measured: From baseline (week 0) to EOS (up to approximately 4 years)

  5. Time to occurrence of CV death

    Measured in months.

    Measured: From baseline (week 0) to EOS (up to approximately 4 years)

  6. Time to occurrence of all-cause death

    Measured in months.

    Measured: From baseline (week 0) to EOS (up to approximately 4 years)

  7. Time to first occurrence of composite CKD endpoint: CV death, onset of a persistent decline in eGFR of ≥30% from baseline, onset of a persistent eGFR <15 mL/min/1.73 m^2, or initiation of chronic KRT, including dialysis or kidney transplantation

    Measured in months. Composite chronic kidney disease (CKD) endpoint comprised of (1) CV death, (2) onset of a persistent decline in estimated glomerular filtration rate (eGFR) of greater than or equal to 30 percent (%) from baseline, (3) onset of a persistent eGFR less than or equal to 15 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2), or (4) initiation of chronic kidney replacement therapy (KRT), including dialysis or kidney transplantation.

    Measured: From baseline (week 0) to EOS (up to approximately 4 years)

  8. Time to hospitalisation due to HF or urgent HF visit

    Measured in months.

    Measured: From baseline (week 0) to EOS (up to approximately 4 years)

  9. Time to CV events (CV hospitalisation and urgent HF visit)

    Measured in months.

    Measured: From baseline (week 0) to EOS (up to approximately 4 years)

  10. Number of occurrences of composite endpoint of CV deaths and recurrent CV events (CV hospitalisation, urgent HF visits, and outpatient HF visits)

    Measured as count of events.

    Measured: From baseline (week 0) to EOS (up to approximately 4 years)

  11. Participant achieving threshold for clinically meaningful within-patient change from the participant's perspective in KCCQ-CSS

    Measured as count of participants.

    Measured: From baseline (week 0) to approximately 2 years

  12. Participant achieving threshold for clinically meaningful within-patient change from the participant's perspective in KCCQ-OSS

    Measured as count of participants.

    Measured: From baseline (week 0) to approximately 2 years

  13. Participant achieving threshold for clinically meaningful within-patient change from the participant's perspective in 6-minute walk test (6MWT)

    Measured as count of participants.

    Measured: From baseline (week 0) to approximately 2 years

  14. Change in stroke volume (SV)

    Measured in milliliter (mL).

    Measured: From baseline (week 0) to week 52

  15. Change in N-terminal pro B-type natriuretic peptide (NT-proBNP)

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to week 52

  16. Change in high-sensitivity (hs) troponin I

    Measured in nanograms per milliliter (ng/mL).

    Measured: From baseline (week 0) to week 52

  17. Change in troponin T

    Measured in ng/mL.

    Measured: From baseline (week 0) to week 52

  18. Hierarchical composite of time to all-cause death as assessed by the win ratio

    Measured as total wins for each treatment group.

    Measured: From baseline (week 0) up to approximately 2 years

  19. Hierarchical composite of number of CV events (CV hospitalisations or urgent HF visits) as assessed by the win ratio

    Measured as total wins for each treatment group.

    Measured: From baseline (week 0) up to approximately 2 years

  20. Hierarchical composite of difference > 15, > 10 and > 5 points in KCCQ-OSS as assessed by the win ratio

    Measured as total wins for each treatment group.

    Measured: From baseline (Week 0) to approximately 2 years

  21. Hierarchical composite of difference > 70 and > 30 meters in 6-minute walk test (6MWT) as assessed by the win ratio

    Measured as total wins for each treatment group.

    Measured: From baseline (Week 0) to approximately 2 years

Timeline

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

  1. First posted6 Oct 2025
  2. Study start2 Oct 2025
  3. Primary completion29 Jun 2029 (estimated)
  4. Study completion29 Jun 2029 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07207811
Sponsor's protocol ID
NN6019-4958
Other IDs
U1111-1315-5366, 2024-518899-31
Acronym
CLEOPATTRA
Status last verified
Oct 2026
First submitted
23 Sep 2025
Last updated
21 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 3 study testing NNC6019-0001 in people with Transthyretin Amyloid Cardiomyopathy (ATTR CM), run by Novo Nordisk A/S at 299 sites in 20 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 15 inclusion and 13 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 21 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 299 sites in United States, China, Italy, Japan, Spain and 15 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Composite Outcome of cardiovascular (CV) deaths and recurrent CV events (CV hospitalisations and urgent heart failure [HF] visits) (time frame: From baseline (week 0) to end of study (EOS) (up to approximately 4 years)). 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 NCT07207811.

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 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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