Long-term safety study of NNC6019-0001 for patients with transthyretin amyloid cardiomyopathy (ATTR-CM)

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What is this study about?

This study focuses on people with transthyretin amyloid cardiomyopathy (ATTR-CM), a condition where abnormal protein deposits build up in the heart muscle, leading to heart failure. The main treatment being studied is coramitug (also known as NNC6019-0001), which is given through an intravenous infusion. This medication is designed to target and remove the harmful protein deposits in the heart.

The purpose of this research is to evaluate how safe and effective long-term treatment with coramitug is for patients with ATTR-CM. During the study, participants will also receive standard medications for heart problems. The study will use various supportive medications including gadoteric acid as a contrast agent for imaging, paracetamol with codeine for pain relief, cetirizine for allergic reactions, and electrolyte solutions containing sodium chloride and other salts.

The study will last for 156 weeks (about 3 years). Throughout this time, participants will have regular check-ups to monitor their heart function and overall health. These check-ups will include various tests to measure heart performance and assess how well the treatment is working. The study will track any side effects that occur during the treatment period.

1 Initial enrollment

Upon joining the study, you must have completed the previous study (NN6019-4940) within the last 12 weeks

Your heart medication doses must have been stable for at least 6 weeks before enrollment

2 Treatment period

The study treatment (NNC6019-0001) will be administered for up to 156 weeks (3 years)

During treatment, you will receive the following medications:

Gadoteric acid through intravenous injection

Paracetamol taken by mouth

Sodium chloride through intravenous injection

Cetirizine taken by mouth

Coramitug through intravenous injection

3 Monitoring and tests

Throughout the study, several tests will be conducted to monitor your health:

6-minute walk test to measure your walking ability

– Blood tests to check levels of substances called NT-proBNP and troponin I

– Heart imaging to measure myocardial extracellular volume

– Quality of life questionnaire (Kansas City Cardiomyopathy Questionnaire)

– Heart ultrasound to measure global longitudinal strain

These tests will be performed regularly up to week 104 (2 years)

4 Safety monitoring

Your health will be monitored for any side effects throughout the entire study period

The total duration of the study is from September 2024 to May 2028

Who Can Join the Study?

  • Must be able to provide informed consent before participating in any study procedures
  • Must have completed previous study treatment (NN6019-4940) and attended the final visit (week 64) within the last 12 weeks
  • Must not have permanently stopped the treatment in the previous study
  • Must be on stable cardiovascular medications (heart and blood vessel medications) for at least 6 weeks before joining the study
  • Must be an adult (18 years or older)
  • Can be either male or female
  • Must have transthyretin amyloid cardiomyopathy (a condition where abnormal proteins build up in the heart muscle)

Who Cannot Join the Study?

  • Age below 18 years or above 80 years
  • Pregnant or breastfeeding women
  • History of heart transplant or currently on waiting list for heart transplant
  • Severe liver or kidney disease (creatinine clearance below 30 mL/min)
  • Active cancer or cancer treatment within the past 2 years
  • Participation in other clinical trials within 30 days before starting this study
  • Known allergic reactions to similar medications
  • Uncontrolled high blood pressure (systolic blood pressure above 180 mmHg or diastolic blood pressure above 100 mmHg)
  • Severe heart failure symptoms that limit daily activities
  • Major surgery planned during the study period
  • Significant heart rhythm problems not controlled by medication
  • Unable to provide informed consent
  • History of substance abuse within the past year
  • Medical conditions that could interfere with study participation or evaluation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Fondazione Toscana Gabriele Monasterio Pisa Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Hopital Beaujon Clichy France
Urmtlmkfadbr Makphhn Cjunrum Geafigdit Groningen The Netherlands
Ucxznbnepfatpnisgipmz Mwbrovjp Aot Munster Germany
Kqpgkvjj doy Uaenucqjvjvi Mjszszdm Apr Munich Germany
Ubgtjrxrvjywkzghusejx Wzufdszrx Aaf Wuerzburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
18.09.2024
France France
Not recruiting
18.09.2024
Germany Germany
Not recruiting
18.09.2024
Italy Italy
Not recruiting
18.09.2024
Portugal Portugal
Not recruiting
18.09.2024
Spain Spain
Not recruiting
18.09.2024
The Netherlands The Netherlands
Not recruiting
18.09.2024

Trial locations

NNC6019-0001 is an investigational medication being studied for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), a condition where abnormal proteins build up in the heart muscle. This medication is being tested to see if it can help patients with both hereditary and wild-type forms of ATTR-CM. The study aims to evaluate how safe and effective this medication is when used over a long period of time (up to 156 weeks).

Transthyretin Amyloid Cardiomyopathy (ATTR-CM) – A rare condition where abnormal proteins called transthyretin build up in the heart muscle tissue. This protein accumulation causes the heart walls to become stiff and thick, making it harder for the heart to function properly. The disease can occur in two forms: hereditary (hATTR), which is passed down through families, or wild-type (wtATTR), which develops with age. The condition progressively affects the heart’s ability to pump blood effectively throughout the body. As the disease advances, it typically leads to symptoms such as shortness of breath, fatigue, and reduced exercise tolerance. The protein deposits can also affect other organs besides the heart.

Trial ID:
2022-502605-15-00
Protocol code:
NN6019-7565
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A Study of Acoramidis in Adult Patients with Transthyretin Amyloidosis with Cardiomyopathy Who Previously Received Tafamidis

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  • A study of coramitug compared to placebo for people with heart failure caused by transthyretin amyloid cardiomyopathy

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