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
Recruiting · NCT07207811 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
NNC6019-0001Placebo (NNC6019-0001)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- 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).
- 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.
Exclusion criteria
- 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.
- 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).
Where it is running
60 locations listed across 28 US states.
- Mayo Clinic Hospital - 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
- 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
Showing 60 of 295 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →