Advancing research
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An investigational medication for ATTR amyloidosis is being developed. Now we need the most important part of research: YOU
Introducing the TRITON‑CM study
TRITON-CM is a clinical research study for individuals who have ATTR amyloidosis with cardiomyopathy.
TRITON‑CM is a phase 3 study to:
The study team will give nucresiran twice a year to people with ATTR amyloidosis with cardiomyopathy. They want to see how it works when compared to a placebo. A placebo is a substance that looks just like the investigational medication but has no active ingredients.
What is the purpose of this study?
This study is being done to find out how effective nucresiran is at reducing heart‑related events like hospitalizations or urgent visits for heart failure in people with ATTR amyloidosis with cardiomyopathy.
Researchers also want to see how nucresiran affects the quality of life of people living with this condition.
Can I be in the TRITON-CM study?
You could be eligible for this study if you:
- Are 18 to 85 years old
- Have ATTR amyloidosis with cardiomyopathy
Study timeline
Screening Period
Up to 45 days
- Assessments and procedures to see if you can be in the study
Double-Blind Treatment Period
2-5 years
- Assessments and procedures to learn about nucresiran
- Monthly check-in contact
- Study visits every 3 months
Open-Label Extension Period
2 years
- Assessments and procedures to learn about nucresiran
- Check-in contact every 6 months
- Study visits every 6 months
Follow-up Period
1-2 years
- Assessments and procedures to monitor your health after you finish taking nucresiran (or placebo)
- Study visits every 6 months
What to expect in TRITON-CM
The TRITON-CM study happens in 4 parts.
- In the Screening Period, we'll determine if you're eligible for the study
- In the Double-Blind Treatment Period, you'll receive either nucresiran or placebo. You'll have a 2 out of 3 chance of receiving nucresiran, and a 1 out of 3 chance of receiving placebo
- In the Open-Label Extension Period, you'll receive nucresiran
- In the Follow-up Period, our study team will keep an eye on your health
TRITON‑CM is an event‑driven study
“Event-driven” means that the ending of the study depends on specific events that happen during the study.
In this case, instead of running the study for a set amount of time, we’ll keep going until we’ve seen a certain number of heart-related events happen.
These events include:
- Urgent heart-failure visits
- Hospitalizations for heart problems
An urgent heart-failure visit is when you seek immediate medical attention, such as at a doctor's office, urgent care clinic, or hospital emergency room, to manage symptoms of worsening heart failure. This could include swelling in the legs or ankles, dizziness, sudden or severe shortness of breath, and/or chest pain. You may have other symptoms not listed here. It is important to seek medical attention if you have any symptoms that you believe could be due to heart failure.
If you have a heart-related event, it’s important to let the study team know right away. The study will end when a certain number of heart-related events are seen. This could take anywhere between 5 and 8 years.
These assessments will help our study team look after the health of your heart.
The study doctor will:
Check your vital signs
(your blood pressure, heart rate, breathing rate, and temperature)
Perform physical exams
Take blood and urine samples
Measure the electrical activity of your heart
(electrocardiogram)
Check your vital signs
(your blood pressure, heart rate, breathing rate, and temperature)
Ask you to complete questionnaires