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 Transthyretin (TTR) Amyloidosis


About this study

The purpose of this study is test the effectiveness and safety of NNC6019-0001 to determine if it can reduce the symptoms of a heart disease due to TTR (Transthyretin ) amyloidosis, such as heart failure.  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Male or female.

- Age greater than or equal to (≥) 18 to less than (<) 85 years at the time of signing
informed consent.

- Have an established diagnosis of Transthyretin amyloid cardiomyopathy (ATTR CM) with
either wild-type transhyretin (TTR) or hereditary transthyretin (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 greater than or equal to
(≥) 12 millimeters (mm).

- Presently classified as New York Heart Association (NYHA) Class II-III.

- N-terminal-pro brain natriuretic peptide (NT-proBNP) concentration greater than or
equal to (≥) 650 picograms per milliliter (pg/mL) in sinus cardiac rhythm and greater
than (>) 1000 pg/mL in atrial fibrillation at screening.

- Completed greater than or equal to (≥) 150 meters to less than or equal to (≤) 450
meters on the 6-minute walk test (MWT) at screening.

- Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 25
milliliter per minute per 1.73 meter square (mL/min/1.73 m^2) at screening.

Exclusion Criteria:

- Cardiomyopathy not primarily caused by transthyretin amyloid cardiomyopathy
transthyretin amyloid cardiomyopathy (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, insitu carcinomas of the cervix, or in-situ/high grade prostatic
intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before

- Current treatment with calcium channel blockers with conduction system effects
(example [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

- Body weight > 120 kilogram (kg) (264.6 pounds [lb]) at screening.

- History of contrast allergy or adverse reactions to gadolinium-containing agents.

Eligibility last updated 7/14/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Melissa Lyle, M.D.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

Rochester, Minn.

Mayo Clinic principal investigator

Martha Grogan, M.D.

Open for enrollment

Contact information:

Amyloid Research Team

(507) 266-4426


Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Julie Rosenthal, M.D.

Contact us for the latest status

Contact information:

Julieta Williams

(480) 342-1785


More information


Publications are currently not available

Mayo Clinic Footer