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.
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
- Conditions the study is for
- Transthyretin Amyloid Cardiomyopathy (ATTR CM)
- 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
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.
299 sites in 20 countries
United States63 sites, 62 recruiting
- 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
- Not yet recruiting
Penn State Milton S.Hershey Medical Center - Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033
- 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
- Not yet recruiting
Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048
- 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
- Not yet recruiting
Saint Louis University
St Louis, Missouri, 63110
- 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
- Completed
Cardiology Associates Research, LLc
Tupelo, Mississippi, 38801
- Recruiting
MedStar Heart & Vascular Institute (MHVI) - MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010-3017
China33 sites, 32 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
- Not yet recruiting
FuWai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, 100037
- 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
- Not yet recruiting
Xiangya Hospital
Changsha, Hunan, 410008
- 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
- Not yet recruiting
Southern Medical University
Guangzhou, Guangdong, 510000
- 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
- Not yet recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
- 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
- Not yet recruiting
Shengjing University Of China Medical University
Liaoning, Liaoning, 110004
- Recruiting
The Second Affiliated Hospital Of Nanchang University
Nanchang, 330000
- Recruiting
Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital)
Nanjing, Jiangsu, 210029
- Terminated
Renji Hospital
Shanghai, Shanghai Municipality, 200127
- Not yet recruiting
Shanghai Jiao Tong University (SJTU) - Shanghai Chest Hospital (SCH)
Shanghaishi, Shanghai Municipality, 200025
- 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
- Not yet recruiting
Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital
Wuhan, Hubei, 430030
- Recruiting
Wuhan University - Renmin Hospital (Hubei General Hospital)
Wuhan, Hubei, 430060
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Italy25 sites, 24 recruiting
- Not yet recruiting
Azienda Ospedaliero Universitaria delle Marche
Ancona - Torrette, 60126
- Recruiting
Policlinico S.Orsola Malpighi, Universita di Bologna
Bologna, 40138
- Not yet recruiting
Azienda Sanitaria del Sudtirol-Ospedale di Bolzano
Bolzano, 39100
- 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
- Not yet recruiting
Azienda Ospedaliera dei Colli - Ospedale Monaldi
Naples, 80131
- Recruiting
University of Naples Federico II
Naples, 80131
- Not yet recruiting
Ospedale S. Luigi Gonzaga
Orbassano, 10043
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127
- Terminated
Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo
Pavia, 27100
- Recruiting
Universita degli Studi di Perugia
Perugia, 06121
- Recruiting
Fondazione Toscana Gabriele Monasterio Per La Ricerca Medica E Di Sanita Pubblica (Ftgm)
Pisa, 56126
- Not yet recruiting
Policlinico Umberto I
Roma, 161
- 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
Japan25 sites, 25 recruiting
- 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
Spain22 sites, 22 recruiting
- 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
- Not yet recruiting
Hospital Universitario Doctor Negrin
Las Palmas de Gran Canaria, 35010
- 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
France20 sites, 19 recruiting
- Recruiting
Centre Hospitalier Universitaire d'Amiens-Picardie - Site Sud
Amiens, 80054
- Not yet recruiting
Hospices Civils de Lyon (HCL) - Hopital Louis Pradel
Bron, 69677
- 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
- Terminated
Private Hospital Medipole
Villeurbanne, 69100
Brazil18 sites, 17 recruiting
- Recruiting
Cardresearch Cardiologia Assistencial e de Pesquisa Ltda
Belo Horizonte, Minas Gerais, 30150-274
- Not yet recruiting
NUPEC Cardio
Belo Horizonte, Minas Gerais, 30220
- Recruiting
Nucleo de Pesquisa Clinica NUPEC
Belo Horizonte, 30220
- Recruiting
L2 IP - Instituto de Pesquisas Clinicas LTDA
Brasília, Federal District, 70200-730
- Not yet recruiting
Universidade Estadual de Campinas - UNICAMP
Campinas, São Paulo, 13083-888
- 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
- Not yet recruiting
Instituto D'Or de Pesquisa e Ensino - Recife
Recife - PE, Recife - PE, 50070-490
- 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
- Terminated
Instituto D'Or de Pesquisa e Ensino - Hospital Cardio Pulmonar (HCP)
Salvador, Estado de Bahia, 40170-130
- Recruiting
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
Canada14 sites, 12 recruiting
- Not yet 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
- Recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 3A7
- Recruiting
Cardio Health Clinical Trials
Hamilton, Ontario, L8W 3K5
- Not yet recruiting
Cardio Health Clinical Trials
Kitchener, N2C 1L3
- Recruiting
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5
- Recruiting
Cardio Health Clinical Trials
Mississauga, Ontario, L5M 2S6
- Terminated
University of Ottawa - Heart Institute (UOHI) (Institut de Cardiologie de L'Universite d'Ottawa)
Ottawa, Ontario, K1Y 4W7
- Not yet recruiting
CIUSSS du Saguenay Lac-Saint-Jean
Québec, Chicoutimi, G7H 7M4
- Recruiting
Hotel Dieu de Quebec
Québec, G1R 2J6
- Not yet recruiting
Centre Hospitalier Regional De Rimouski
Rimouski, G5L 5T1
- Completed
Cardio Health Clinical Trials
Scarborough Village, Ontario, M1B 0A7
- Recruiting
Riverside Cardiology and Diagnostic Imaging
Toronto, Ontario, M6N 1B5
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V6Z 1Y6
Belgium12 sites, 12 recruiting
- 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
- Not yet 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
- Recruiting
Clinique Universitaire de Mont Godinne
Yvoir, 5530
Germany12 sites, 12 recruiting
- 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
- Not yet recruiting
University Hospital Frankfurt
Frankfurt am Main, 60590
- Recruiting
University Heart Center Freiburg
Freiburg im Breisgau, 79106
- Recruiting
Universitaetsklinikum Jena
Jena, 07747
- Recruiting
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105
- Not yet recruiting
Deutsches Herzzentrum Muenchen
München, 80636
- Not yet recruiting
University of Munich (LMU)-Grosshadern Hospital
Munich, 81377
- Recruiting
Universitaetsklinikum Muenster
Münster, 48149
- Recruiting
University of Wurzburg, Comprehensive Heart Failure Center (CHFC)
Würzburg, 97078
Australia11 sites, 11 recruiting
- 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
- Not yet recruiting
ST Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
- 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
Argentina9 sites, 9 recruiting
- Not yet 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
Czechia7 sites, 7 recruiting
- Not yet recruiting
Fakultni nemocnice u sv. Anny v Brne
Brno, 602 00
- Recruiting
Edumed s.r.o.
Broumov, Hradec Králové Region, 55101
- Recruiting
Fakultni nemocnice Olomouc
Olomouc, 779 00
- Not yet 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
- Recruiting
IKEM, Kardiologicka klinika
Prague, 140 21
- Recruiting
Clinical Trials Service s.r.o.
Uherské Hradiště, 686 01
United Kingdom7 sites, 6 recruiting
- 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
- Terminated
Synexus Merseyside Clinical Research Centre
Liverpool, L22 0LG
- Recruiting
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
South Korea6 sites, 6 recruiting
- 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
Netherlands4 sites, 4 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
- Not yet recruiting
Maastricht University Medical Center (MUMC)
Maastricht, 6229 HX
- Recruiting
Erasmus Medisch Centrum 1
Rotterdam, South Holland, 3015 GD
- Recruiting
Universitair Medisch Centrum Utrecht (UMC Utrecht)
Utrecht, 3584 CX
Denmark3 sites, 3 recruiting
- 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
Ireland3 sites, 3 recruiting
- Not yet 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
Poland3 sites, 3 recruiting
- Not yet 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
Sweden2 sites, 2 recruiting
- Not yet recruiting
Karolinska Universitetssjukhuset (Karolinska University Hospital)
Huddinge, 141 86
- Not yet recruiting
Umea University Hospital
Umeå, 90185
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 group | Role | What they receive |
|---|---|---|
| NNC6019-0001 | Experimental | Participants 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 |
| Placebo | Placebo comparator | Participants 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.
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)
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
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
Change in 6-minute walk distance (6MWD)
Measured in meters.
Measured: From baseline (week 0) to approximately 2 years
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)
Time to occurrence of CV death
Measured in months.
Measured: From baseline (week 0) to EOS (up to approximately 4 years)
Time to occurrence of all-cause death
Measured in months.
Measured: From baseline (week 0) to EOS (up to approximately 4 years)
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)
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)
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)
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)
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
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
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
Change in stroke volume (SV)
Measured in milliliter (mL).
Measured: From baseline (week 0) to week 52
Change in N-terminal pro B-type natriuretic peptide (NT-proBNP)
Measured as ratio to baseline.
Measured: From baseline (week 0) to week 52
Change in high-sensitivity (hs) troponin I
Measured in nanograms per milliliter (ng/mL).
Measured: From baseline (week 0) to week 52
Change in troponin T
Measured in ng/mL.
Measured: From baseline (week 0) to week 52
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
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
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
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.
- First posted6 Oct 2025
- Study start2 Oct 2025
- Primary completion29 Jun 2029 (estimated)
- Study completion29 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin Amyloid Cardiomyopathy (ATTR CM)Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
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