Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

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

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

14 criteria

  • 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
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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).

What is already known about the treatment

NNC6019-0001 - An investigational therapeutic agent being studied for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), a rare and serious heart condition. This medication is currently undergoing clinical trials to evaluate its long-term safety and efficacy in patients with both hereditary and wild-type ATTR cardiomyopathy. While the specific mechanism of action and administration route are not publicly disclosed in the current trial data, the drug is being investigated as a potential treatment option for managing cardiac complications associated with protein misfolding in ATTR-CM patients, with the study duration extending up to 156 weeks to assess its long-term effects and safety profile.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502605-15-00Protocol codeNN6019-7565Estimated enrolment89 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.