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RECRUITING

NCT07207811

PHASE3

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

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1280

Start Date

2025-10-02

Completion Date

2029-06-29

Last Updated

2026-10-21

Healthy Volunteers

Conditions

Transthyretin Amyloid Cardiomyopathy (ATTR CM)

Interventions

DRUG

NNC6019-0001

NNC6019-0001 will be administered IV.

DRUG

Placebo (NNC6019-0001)

Placebo matched to NNC6019-0001 will be administered IV.

Inclusion Criteria: 1. Male or female. 2. Age 18 years or above at the time of signing the informed consent. 3. 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. a. 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: * 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. b. Increased LV wall thickness, as assessed by centralised review of echocardiography, showing interventricular septal wall thickness greater than or equal to 12 millimeter (mm). c. 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). 4. 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. 5. Completed more than 50 meters on the 6MWT at screening. Exclusion Criteria: 1. Known or suspected hypersensitivity to study intervention(s) or related products. 2. Current or previous participation (dosing with active treatment) in a study for an investigational ATTR depleting drug or ATTR gene editing therapy. 3. Total bilirubin greater than 3 times the upper limit of normal (ULN) at screening. 4. Current diagnosis or history of amyloid light chain, other non-ATTR amyloidosis, known leptomeningeal amyloidosis, or multiple myeloma. 5. 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). 6. Currently hospitalised or hospitalised within 14 days prior to screening. 7. Currently treated with positive inotropic medication. 8. Uncorrected, severe, haemodynamically significant, left-sided heart valve disease. 9. 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. 10. Prior solid organ transplant or planned solid organ transplant during the study. 11. Left ventricular ejection fraction (LVEF) less than 30 percent as assessed by centralised review of echocardiography. 12. 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. 13. 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).

Locations (299)

Mayo Clinic in Arizona

Phoenix, Arizona, United States

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

La Jolla, California, United States

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

Los Angeles, California, United States

Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, United States

UCI Medical Center

Orange, California, United States

Profound Research LLC at Southern California Heart Specialists

Pasadena, California, United States

University of California, San Francisco Medical Center

San Francisco, California, United States

NorthBay Clinical Research

Santa Rosa, California, United States

Lucile Packard Children's Hospital

Stanford, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

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

Washington D.C., District of Columbia, United States

UF Health Heart and Vascular Hospital

Gainesville, Florida, United States

Northeast Georgia Heart Center, Pc (Nghc)

Gainesville, Georgia, United States

The Queen's Medical Center

Honolulu, Hawaii, United States

Northwestern University Clinical and Translational Sciences Institute

Chicago, Illinois, United States

The University of Chicago Medicine

Chicago, Illinois, United States

Endeavor Health - Glenbrook Hospital

Glenview, Illinois, United States

Indiana University (IU) Health - Methodist Professional Center II

Indianapolis, Indiana, United States

LCMC - LSU University Medical Center New Orleans LCMC Center

New Orleans, Louisiana, United States

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

Baltimore, Maryland, United States

John Hopkins Medicine

Baltimore, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Henry Ford Health

Detroit, Michigan, United States

Profound Research

Farmington Hills, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Cardiology Associates Research, LLc

Tupelo, Mississippi, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Saint Louis University

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

North Shore University Hospital, Northwell Health

Manhasset, New York, United States

NYU Langone Health

New York, New York, United States

Weill Medical College Of Cornell University

New York, New York, United States

Mount Sinai Medical Center

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Laurelton Heart Specialist, PC

Rosedale, New York, United States

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

The Bronx, New York, United States

Duke University Health System

Durham, North Carolina, United States

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

Cincinnati, Ohio, United States

Cleveland Clinic - Taussig Cancer Institute

Cleveland, Ohio, United States

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Jefferson Health

Abington, Pennsylvania, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

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

Hershey, Pennsylvania, United States

The Heart Group of Lancaster General Health

Lancaster, Pennsylvania, United States

Penn Medicine: University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Prisma Health

Greenville, South Carolina, United States

Saint Thomas Health

Nashville, Tennessee, United States

Ascension Texas Cardiovascular Research Institute

Austin, Texas, United States

St. Davids Heart and Vascular

Austin, Texas, United States

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

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Baylor St. Luke Medical Center

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Baylor Scott & White The Heart Hospital

Plano, Texas, United States

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

Murray, Utah, United States

Inova Fairfax Hospital - Inova Heart and Vascular Institute

Falls Church, Virginia, United States

Sentara Cardiovascular Research Institute

Norfolk, Virginia, United States

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, United States

Hospital Italiano de Buenos Aires (HIBA)

Buenos Aires, Argentina

Centro Medico dr Besada

Buenos Aires, Argentina

Nexo salud

Buenos Aires, Argentina

Icba - Instituto Cardiovascular De Buenos Aires

Buenos Aires, Argentina

Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

Caba, Argentina

Instituto de Cardiologia de Corrientes Juana Fca. Cabral

Corrientes, Argentina

Hospital Privado Centro Medico de Cordoba S.A.

Córdoba, Argentina

Dim Clinica Privada

Ramos Mejía, Argentina

Centro de Investigaciones Clinicas del Litoral

Santa Fe, Argentina

ST Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Liverpool Renal Clinical Research Centre

Liverpool, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Metro South Health - Princess Alexandra Hospital (PAH)

Woolloongabba, Queensland, Australia

Central Adelaide Local Health Network - Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Centre

Adelaide, South Australia, Australia

Hobart Hospital-Royal Hobart Hospital

Hobart, Tasmania, Australia

Victorian Heart Hospital

Clayton, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Joondalup Cardiovascular Trials Foundation Inc.

Joondalup, Western Australia, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel

Brussels, Anderlecht, Belgium

Universitair Ziekenhuis Brussel

Jette, Brusselss, Belgium

ZOL Genk, Campus Sint-Jan

Waterschei-Zwartberg, Limburg, Belgium

AZORG Ziekenhuis

Aalst, Oost-Vlaanderen, Belgium

Algemeen Ziekenhuis Sint-Blasius (AZSB)

Sint-Gillis-Dendermonde, Oost-Vlaanderen, Belgium

Az Middelheim

Antwerp, Belgium

Algemeen Ziekenhuis Sint-Jan

Bruges, Belgium

Ziekenhuis Oost-Limburg (ZOL)

Genk, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

Centre Hospitalier Regional CHR de la Citadelle

Liège, Belgium

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

Roeselare, Belgium

Clinique Universitaire de Mont Godinne

Yvoir, Belgium

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

Salvador, Estado de Bahia, Brazil

L2 IP - Instituto de Pesquisas Clinicas LTDA

Brasília, Federal District, Brazil

Cardresearch Cardiologia Assistencial e de Pesquisa Ltda

Belo Horizonte, Minas Gerais, Brazil

NUPEC Cardio

Belo Horizonte, Minas Gerais, Brazil

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

Uberlândia, Minas Gerais, Brazil

And 199 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (299)