Authorised Therapeutic confirmatory (Phase III) Variant or wild-type transthyretin (TTR) amyloid cardiomyopathy

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

EU CTIS ID: 2024-518899-31-00

What this study is testing

To demonstrate superiority of NNC6019-0001 versus placebo, both added to SoCa, in reducing CV death and morbidity in participants with ATTRwt‑CM or ATTRv‑CM

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

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, (ATTRwt or ATTRv), with cardiac amyloid infiltration, increased left ventricular (LV) wall thickness, and HF. Note: Target ATTRv recruitment is approximately 15% 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 PYP/DPD/HMDP scintigraphy with single-photon emission computed tomography (SPECT/CT) combined with an extracardiac biopsy positive for TTR amyloid, OR, iii. 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: o Non-invasive diagnostic pathway will be confirmed by a centralised expert review. o 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)/99mTc-labeled hydroxymethylene diphosphonate (99mTc-HMDP). b. Increased LV wall thickness, as assessed by centralised review of echocardiography, showing interventricular septal wall thickness ≥12 mm. c. Chronic HF (New York Heart Classification [NYHA] I-IV) requiring ongoing treatment with a loop diuretic with: 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).
4. Expected to be on stable CV medical therapy (defined as no greater than 50% dose adjustment and no categorical changes of medications), with the exception of diuretics, 4 weeks prior to the randomisation visit.
5. NT-proBNP concentration ≥"CCI" pg/mL at screening. Note: Participants with NT-proBNP levels between "CCI" and "CCI" pg/mL may be enrolled until a cap of 35% of the total study population is reached.
6. Completed >50 meters on the 6MWT at screening.

You likely can't join if

1. Known or suspected hypersensitivity to study intervention(s) or related products.
10. Prior solid organ transplant or planned solid organ transplant during the study.
11. Left ventricular ejection fraction (LVEF) <30% 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, or 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) <15 ml/min/1.73m2 at screening, or chronic/intermittent haemodialysis or peritoneal dialysis).
2. Current or previous participation (dosing with active treatment) in a study for an investigational ATTR depleting drug or ATTR gene editing therapy.

See the full eligibility criteria

Who can join

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, (ATTRwt or ATTRv), with cardiac amyloid infiltration, increased left ventricular (LV) wall thickness, and HF. Note: Target ATTRv recruitment is approximately 15% 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 PYP/DPD/HMDP scintigraphy with single-photon emission computed tomography (SPECT/CT) combined with an extracardiac biopsy positive for TTR amyloid, OR, iii. 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: o Non-invasive diagnostic pathway will be confirmed by a centralised expert review. o 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)/99mTc-labeled hydroxymethylene diphosphonate (99mTc-HMDP). b. Increased LV wall thickness, as assessed by centralised review of echocardiography, showing interventricular septal wall thickness ≥12 mm. c. Chronic HF (New York Heart Classification [NYHA] I-IV) requiring ongoing treatment with a loop diuretic with: 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).
4. Expected to be on stable CV medical therapy (defined as no greater than 50% dose adjustment and no categorical changes of medications), with the exception of diuretics, 4 weeks prior to the randomisation visit.
5. NT-proBNP concentration ≥"CCI" pg/mL at screening. Note: Participants with NT-proBNP levels between "CCI" and "CCI" pg/mL may be enrolled until a cap of 35% of the total study population is reached.
6. Completed >50 meters on the 6MWT at screening.

What rules you out

1. Known or suspected hypersensitivity to study intervention(s) or related products.
10. Prior solid organ transplant or planned solid organ transplant during the study.
11. Left ventricular ejection fraction (LVEF) <30% 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, or 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) <15 ml/min/1.73m2 at screening, or chronic/intermittent haemodialysis or peritoneal dialysis).
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 >3 × upper limit of normal (ULN) at screening.
4. Current diagnosis or history of amyloid light chain, other non-ATTR amyloidosis or known leptomeningeal amyloidosis, or multiple myeloma.
5. HF not primarily caused by ATTR-CM, for example, 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. Note: pre existing echocardiogram up to 2 years old may be used.
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.

The study team makes the final eligibility decision.

Where it's taking place

United Kingdom
Brazil
Korea, Republic of
Australia
China
United States
Japan
Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom; Brazil; Korea, Republic of; Australia; China; United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.