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Acoramidis

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.

Table of Contents

Trial overview

This article covers one interventional study of Acoramidis in people with transthyretin amyloid cardiomyopathy, also called ATTR-CM.[1] The study is designed to learn more about the change in blood transthyretin, or TTR, after participants switch from tafamidis to Acoramidis.[1]

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.[1] The brief summary says the study is for patients with ATTR-CM who switched from tafamidis to Acoramidis.[1]

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.[1] The trial data do not list extra participation rules beyond this group in the source provided.[1]

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.[1] Baseline means the starting point before the study treatment effect is measured.[1]

Serum TTR level means the amount of transthyretin measured in the blood.[1] In simple terms, the researchers want to see whether the blood level of this protein changes after the switch to Acoramidis.[1]

Study design and phase

This is a Phase 3 study.[1] Phase 3 trials usually test a treatment in a larger group of patients and help researchers understand its effects in real-world clinical use.[1]

The study type is interventional, which means participants receive the study treatment and researchers observe what happens.[1] The intervention listed in the source is BEYONTTRA 356 mg film-coated tablets, given by mouth.[1]

Trial status and size

The trial status is Authorised, meaning it has been approved to proceed according to the source data.[1] The planned enrollment is 68 participants.[1]

Because only one trial is provided in the source data, this article focuses on that single study rather than comparing multiple trials.[1]

Trial ID Phase Condition studied Status Enrollment
2025-521831-35-00 Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Authorised 68

FAQ

  • What is being studied in Acoramidis clinical trials? The trial is studying changes in blood transthyretin, also called TTR, after patients switch from tafamidis to Acoramidis. The main goal is to see how treatment affects serum TTR levels over time.
  • Who can take part in the trial? The study is for participants with transthyretin amyloidosis with cardiomyopathy, also called ATTR-CM. It focuses on people who were taking tafamidis and then switched to Acoramidis.
  • What phase is the Acoramidis trial? This study is a Phase 3 trial. Phase 3 trials usually involve larger groups of people and help researchers learn more about how a treatment performs in real patients.
  • What condition is the trial focused on? The trial focuses on transthyretin amyloid cardiomyopathy, or ATTR-CM. This is a heart condition linked to transthyretin amyloidosis.
  • What is the main result the researchers want to measure? The main result is the change in serum TTR level from the start of the study to month 6, or until treatment stops early. This helps show how the body responds to Acoramidis.

Ongoing Clinical Trials on Acoramidis

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

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Germany Italy

Glossary

  • Acoramidis: The study drug being tested in this clinical trial.
  • ATTR-CM: Short for transthyretin amyloid cardiomyopathy. This is a heart disease caused by amyloid buildup linked to transthyretin.
  • Transthyretin (TTR): A protein found in the blood. In this trial, researchers measure its serum level to see how treatment changes it.
  • Serum TTR level: The amount of transthyretin measured in the blood. Serum means the liquid part of blood.
  • Baseline: The starting point before treatment changes are measured.
  • Month 6: A follow-up time point six months after the start of treatment.
  • Premature discontinuation: When treatment stops earlier than planned.
  • Phase 3: A later stage of clinical research that tests a treatment in a larger group of patients.
  • Interventional study: A study where participants receive a treatment so researchers can measure its effects.
  • Authorised: The study has approval to start or continue.

References

  1. https://clinicaltrials.gov/study/2025-521831-35-00