NIPH Clinical Trials Search

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 ATTR amyloidosis.

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Transthyretin amyloid cardiomyopathy (wild-type and variant)
Date of first enrollment	25/12/2025
Target sample size	50
Countries of recruitment	Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czechia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Italy,Japan,Netherlands,Japan,South Korea,Japan,Spain,Japan,United Kingdom,Japan,United States,Japan
Study type	Interventional
Intervention(s)	- Drug: NNC6019-0001 NNC6019-0001 will be administered IV. - Drug: Placebo (NNC6019-0001) Placebo matched to NNC6019-0001 will be administered IV.

Outcome(s)

Primary Outcome	Number of occurrences of composite endpoint of cardiovascular (CV) deaths and recurrent CV events (CV hospitalisations and urgent heart failure [HF] visits) [Time Frame: From baseline (week 0) to end of study (EOS) (up to approximately 4 years)] - Measured as count of events.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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. 1. 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).
Exclude criteria	- 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).