Study on the Effects and Safety of Coramitug for Patients with Transthyretin Amyloid Cardiomyopathy (ATTR CM)

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What is this study about?

This clinical trial is focused on studying a heart condition known as transthyretin amyloid cardiomyopathy (ATTR CM). This condition occurs when a protein called transthyretin misfolds and forms clumps in the heart, leading to heart disease. The study will test a new treatment called NNC6019-0001, also known as coramitug, which is a type of protein designed to target and help manage this condition. Participants in the study will receive either the new treatment or a placebo.

The purpose of the study is to evaluate how effective and safe the new treatment is for people with ATTR CM. The study will last for about a year, during which participants will receive the treatment through an intravenous infusion, meaning it will be administered directly into a vein. The study will monitor changes in participants’ ability to walk over six minutes and measure a heart-related protein called NT-proBNP to assess the treatment’s impact.

Throughout the study, participants will have regular check-ups to monitor their heart health and overall well-being. The study aims to provide valuable information on whether the new treatment can improve symptoms and quality of life for those with ATTR CM. Participants’ safety and any side effects will be closely observed to ensure the treatment is safe for use.

1 initial visit

Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria such as age, diagnosis of transthyretin amyloid cardiomyopathy (ATTR CM), and other health parameters.

A series of tests are conducted, including a 6-minute walk test to measure the distance walked in six minutes, and blood tests to check levels of NT-proBNP, a marker related to heart function.

2 randomization

Participants are randomly assigned to receive either the new medicine NNC6019-0001 or a placebo. This is done to compare the effects of the medicine against no active treatment.

The medicine or placebo is administered as a solution for infusion, which means it is given through a vein (intravenously).

3 treatment phase

The treatment phase lasts for 52 weeks. During this time, the medicine or placebo is administered at regular intervals as specified by the study protocol.

Participants continue to receive their usual cardiovascular medical therapy, which should remain stable throughout the study.

4 regular assessments

Throughout the study, regular assessments are conducted to monitor health and the effects of the treatment. These include repeating the 6-minute walk test and blood tests for NT-proBNP levels.

Additional assessments may include heart imaging tests and questionnaires about health and quality of life.

5 final visit

At the end of the 52-week treatment phase, a final visit is conducted. This includes a comprehensive evaluation similar to the initial visit.

The results from the final assessments are compared to the initial results to determine the effects of the treatment.

6 follow-up

A follow-up period extends to week 64 to monitor any long-term effects or adverse events related to the treatment.

Participants are observed for any changes in health status, including heart-related events or overall mortality.

Who Can Join the Study?

Must be male or female.
Must be between 18 and 84 years old at the time of signing the consent form.
Must have a confirmed diagnosis of ATTR CM (a type of heart condition) with either wild-type or hereditary TTR gene.
Should be on stable doses of heart-related medications for at least 6 weeks before the study starts.
Must have a known heart wall thickness of 12 mm or more.
Should be classified as New York Heart Association (NYHA) Class II-III, which means having mild to moderate heart failure symptoms.
Must have a blood test result showing NT-proBNP concentration of at least 650 pg/mL if in normal heart rhythm, or more than 1000 pg/mL if in atrial fibrillation (a type of irregular heartbeat).
Must be able to walk between 150 meters and 450 meters in a 6-minute walk test during screening.
Must have a kidney function test result showing an estimated glomerular filtration rate (eGFR) of at least 25 mL/min/1.73 m² during screening.

Who Cannot Join the Study?

Patients who do not have a confirmed diagnosis of ATTR cardiomyopathy cannot participate. ATTR cardiomyopathy is a heart condition caused by abnormal protein deposits in the heart.
Patients who are not within the specified age range for the study cannot participate. The study includes adults and older adults.
Patients who are not able to perform a 6-minute walk test cannot participate. This test measures how far you can walk in six minutes and is used to assess heart and lung function.
Patients who have conditions that might interfere with the study results cannot participate. This includes other serious health issues that could affect the heart or overall health.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to follow the study procedures or attend the required visits cannot participate.

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

Other Sites

Site Name	City	Country
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Universitaetsklinikum Wuerzburg AöR	Wuerzburg	Germany
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.	Vila Real	Portugal
Westfaelische Wilhelms Universitaet Muenster	Munster	Germany
Flzzkezqtz Tecltvj Gqqnkxpj Mmpzndsyik	Pisa	Italy
Kkgnlvgt djm Ukixfslnrwjs Mawvptay Akm	Munich	Germany
Uxxflyhonunj Mgtjxmc Cveghnl Gxstpqnxv	Groningen	The Netherlands
Hwbbuhc Hyuja Mzuiwj &langen 1 reu Gomdcka Epknsy	Creteil	France

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	02.08.2022
France	Not recruiting	02.08.2022
Germany	Not recruiting	02.08.2022
Italy	Not recruiting	02.08.2022
Portugal	Not recruiting	02.08.2022
Spain	Not recruiting	02.08.2022
The Netherlands	Not recruiting	02.08.2022

Trial locations

NNC6019-0001 is a medication being studied for its potential to help people with a heart condition called transthyretin amyloid cardiomyopathy, or ATTR CM. This condition affects the heart’s ability to function properly. The medication is being tested to see if it can improve how far patients can walk in six minutes and reduce a specific heart-related protein in the blood, which is a sign of heart stress. The goal is to see if this medication can help improve heart health and overall well-being in people with this condition.

Transthyretin Amyloid Cardiomyopathy – Transthyretin Amyloid Cardiomyopathy (ATTR-CM) is a condition where abnormal protein deposits, known as amyloid, accumulate in the heart tissue. This accumulation leads to the thickening and stiffening of the heart walls, which can impair the heart’s ability to pump blood effectively. Over time, this can result in symptoms such as fatigue, shortness of breath, and swelling in the legs and abdomen. The disease can be hereditary, known as hereditary ATTR (hATTR), or occur without a genetic cause, referred to as wild-type ATTR (wtATTR). As the condition progresses, it can lead to more severe heart-related symptoms and complications. ATTR-CM is considered a rare disease, affecting a small percentage of the population.

Trial ID:

2023-506824-96-00

Protocol code:

NN6019-4940

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects and Safety of Coramitug for Patients with Transthyretin Amyloid Cardiomyopathy (ATTR CM)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?