In short
Acoramidis is being studied in clinical trials for transthyretin amyloid cardiomyopathy, a heart condition linked to abnormal transthyretin protein. These trials look at how well it works and how safe it is in specific patient groups, especially people switching from tafamidis.
Key points
- Acoramidis is being studied in a Phase 3 clinical trial in people with transthyretin amyloid cardiomyopathy, also called ATTR-CM. The study looks at patients who switched from tafamidis to Acoramidis. Researchers want to measure the change in serum transthyretin, or TTR, from the start of treatment to month 6, or until treatment stops early. The trial is interventional, which means participants receive the study treatment so its effects can be measured. The planned enrollment is 68 participants. The study status is authorised.
Trial overview
This article covers one interventional study of Acoramidis in people with transthyretin amyloid cardiomyopathy, also called ATTR-CM. The study is designed to learn more about the change in blood transthyretin, or TTR, after participants switch from tafamidis to Acoramidis.
Who is being studied
The trial focuses on participants with transthyretin amyloidosis with cardiomyopathy, which is a heart condition linked to amyloid buildup from transthyretin. The brief summary says the study is for patients with ATTR-CM who switched from tafamidis to Acoramidis.
This means the target population is not a broad group of all heart patients, but a more specific group already living with ATTR-CM and changing treatment. The trial data do not list extra participation rules beyond this group in the source provided.
What the trial is measuring
The main endpoint is the change in serum TTR level from baseline to month 6, or until premature discontinuation of treatment. Baseline means the starting point before the study treatment effect is measured.
Serum TTR level means the amount of transthyretin measured in the blood. In simple terms, the researchers want to see whether the blood level of this protein changes after the switch to Acoramidis.
Study design and phase
This is a Phase 3 study. Phase 3 trials usually test a treatment in a larger group of patients and help researchers understand its effects in real-world clinical use.
The study type is interventional, which means participants receive the study treatment and researchers observe what happens. The intervention listed in the source is BEYONTTRA 356 mg film-coated tablets, given by mouth.
Trial status and size
The trial status is Authorised, meaning it has been approved to proceed according to the source data. The planned enrollment is 68 participants.
Because only one trial is provided in the source data, this article focuses on that single study rather than comparing multiple trials.