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A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have heart disease due to TTR amyloidosis.
EU CTIS ID: 2023-506824-96-00
What this study is testing
To compare the effect of two dose levels of NNC6019-0001 (xx and xx) versus placebo on, change in 6-minute walk test and change in NT-proBNP from baseline to week 52 in participants with hereditary ATTR (hATTR) or wild-type ATTR (wtATTR) cardiomyopathy.
- Therapeutic exploratory (Phase II)
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
- Male or female.
- Age ≥ 18 to < 85 years at the time of signing informed consent.
- Have an established diagnosis of ATTR CM with either wild-type TTR or hereditary TTR genotype as per local standards.
- Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the randomisation visit.
- Known end-diastolic interventricular septal wall thickness ≥ 12 mm.
- Presently classified as New York Heart Association (NYHA) Class II-III.
You likely can't join if
- Cardiomyopathy not primarily caused by ATTR CM, for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease
- A prior solid organ transplant.
- Planned solid organ transplant during the study.
- Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before screening.
- Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response.
- Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularization, cardiac valve repair, or major surgery within 3 months of screening.
See the full eligibility criteria
- Male or female.
- Age ≥ 18 to < 85 years at the time of signing informed consent.
- Have an established diagnosis of ATTR CM with either wild-type TTR or hereditary TTR genotype as per local standards.
- Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the randomisation visit.
- Known end-diastolic interventricular septal wall thickness ≥ 12 mm.
- Presently classified as New York Heart Association (NYHA) Class II-III.
- NT-proBNP concentration ≥650 pg/mL in sinus cardiac rhythm and >1000 pg/mL in atrial fibrillation at screening.
- Completed ≥150 meters to ≤450 meters on the 6MWT at screening.
- Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 at screening.
- Cardiomyopathy not primarily caused by ATTR CM, for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease
- A prior solid organ transplant.
- Planned solid organ transplant during the study.
- Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before screening.
- Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response.
- Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularization, cardiac valve repair, or major surgery within 3 months of screening.
- Body weight >120 kg (264.6 lb) at screening.
- History of contrast allergy or adverse reactions to gadolinium-containing agents.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
- 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.