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Clinical Trials in Ireland / NCT07207811
Recruiting Phase 3

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

NCT07207811 · tracked via the Priya Life Science Ireland tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2025-10-02
Last updated
2026-08-19

Condition(s) studied

Transthyretin Amyloid Cardiomyopathy (ATTR CM)

Investigational drug(s) / intervention(s)

NNC6019-0001Placebo (NNC6019-0001)

NNC6019-0001: NNC6019-0001 will be administered IV.

Placebo (NNC6019-0001): Placebo matched to NNC6019-0001 will be administered IV.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (295)

FacilityCityRegionStatus
Mayo Clinic Hospital Phoenix Arizona Not Yet Recruiting
University of California San Diego (UCSD) - Sulpizio Cardiovascular Center (SCVC) La Jolla California Recruiting
Keck School of Medicine USC - Healthcare Consultation Center 2 (HCCII) Los Angeles California Not Yet Recruiting
Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute Los Angeles California Not Yet Recruiting
UCI Medical Center Orange California Not Yet Recruiting
Profound Research LLC at Southern California Heart Specialists Pasadena California Recruiting
University of California, San Francisco Medical Center San Francisco California Recruiting
NorthBay Clinical Research Santa Rosa California Recruiting
Lucile Packard Children's Hospital Stanford California Recruiting
Yale University School of Medicine New Haven Connecticut Recruiting
MedStar Heart & Vascular Institute (MHVI) - MedStar Washington Hospital Center Washington D.C. District of Columbia Recruiting
UF Health Heart and Vascular Hospital Gainesville Florida Not Yet Recruiting
Northeast Georgia Heart Center, Pc (Nghc) Gainesville Georgia Recruiting
The Queen's Medical Center Honolulu Hawaii Recruiting
Northwestern University Clinical and Translational Sciences Institute Chicago Illinois Recruiting
The University of Chicago Medicine Chicago Illinois Recruiting
Endeavor Health - Glenbrook Hospital Glenview Illinois Recruiting
Indiana University (IU) Health - Methodist Professional Center II Indianapolis Indiana Recruiting
LCMC - LSU University Medical Center New Orleans LCMC Center New Orleans Louisiana Recruiting
University of Maryland Medical Center (UMMC) - Children's Hospital (UMCH) Baltimore Maryland Recruiting
John Hopkins Medicine Baltimore Maryland Not Yet Recruiting
Tufts Medical Center Boston Massachusetts Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
University of Michigan Health System Ann Arbor Michigan Recruiting
Henry Ford Health Detroit Michigan Recruiting
Profound Research Farmington Hills Michigan Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Cardiology Associates Research, LLc Tupelo Mississippi Completed
Saint Luke's Hospital of Kansas City Kansas City Missouri Recruiting
Saint Louis University St Louis Missouri Not Yet Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
North Shore University Hospital, Northwell Health Manhasset New York Recruiting
NYU Langone Health New York New York Recruiting
Weill Medical College Of Cornell University New York New York Recruiting
Mount Sinai Medical Center New York New York Recruiting
Columbia University Medical Center New York New York Recruiting
Laurelton Heart Specialist, PC Rosedale New York Recruiting
Yeshiva University - Albert Einstein College of Medicine - Montefiore Medical Center (MMC) The Bronx New York Recruiting
Duke University Health System Durham North Carolina Not Yet Recruiting

+ 255 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07207811 on ClinicalTrials.gov ↗ ← All trials in Ireland