Status:
RECRUITING
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
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Transthyretin Amyloid Cardiomyopathy (ATTR CM)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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:
- Cardiac biopsy positive for TTR amyloid, OR
- Grade 2 or 3 cardiac uptake at pyrophosphate (PYP)/diphosphono-1,2-propanodicarboxylic acid (DPD)/ hydroxymethylene diphosphonate (HMDP) scintigraphy with single-photon emission computed tomography (SPECT/CT) combined with an extracardiac biopsy positive for TTR amyloid, OR
- Grade 2 or 3 cardiac uptake at PYP/DPD/HMDP scintigraphy with SPECT/CT combined with normal serum free light chain ratio, and negative serum and urine protein electrophoresis with immunofixation (SPIE \& UPIE).
- Notes:
- Non-invasive diagnostic pathway will be confirmed by a centralised expert review.
- Bone tracer scintigraphy 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).
- 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) requiring ongoing treatment with a loop diuretic with:
- At least 1 documented hospitalisation for HF, OR
- 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).
- 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
- 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.
- Note: Pre-existing echocardiogram up to 2 years old may be used.
- 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).
Key Trial Info
Start Date :
October 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 29 2029
Estimated Enrollment :
1280 Patients enrolled
Trial Details
Trial ID
NCT07207811
Start Date
October 2 2025
End Date
June 29 2029
Last Update
January 9 2026
Active Locations (276)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
University of California San Diego (UCSD) - Sulpizio Cardiovascular Center (SCVC)
La Jolla, California, United States, 92037
3
Keck School of Medicine USC - Healthcare Consultation Center 2 (HCCII)
Los Angeles, California, United States, 90033
4
UCI Medical Center
Orange, California, United States, 92868