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

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What is this trial about?

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

This study involves people with transthyretin amyloid cardiomyopathy, a condition where an abnormal protein called transthyretin builds up in the heart muscle and causes the heart to work less effectively. The study will use a medication called acoramidis, which is also known by its code name BAY 3684938 and is marketed as BEYONTTRA. Participants in this study will be switching from another medication called tafamidis, which they have been taking for at least three months before joining the study. The purpose of this study is to measure how the levels of transthyretin protein in the blood change when people switch from tafamidis to acoramidis.

During the study, participants will take acoramidis as film-coated tablets by mouth. The study will last for six months, during which blood samples will be taken at different times to measure the amount of transthyretin protein and other substances in the blood. These measurements will be taken at the beginning of the study, then at week one, two, three, and four, and again at month three and month six. The study will also check how the heart is functioning using an ultrasound examination of the heart called ECHO, and will measure how far participants can walk in six minutes, which is called 6MWD. Other tests will look at kidney function, thyroid function, and various markers in the blood that can show how the heart and body are responding to the medication.

Throughout the study, doctors will monitor participants for any unwanted effects or health problems that may occur. The study will also use questionnaires to assess how participants feel and how the condition affects their daily life, including one called KCCQ-OS that focuses on heart-related quality of life and another called EQ-5D-5L that measures general health and wellbeing. Blood tests will check several markers including NT-proBNP, which indicates heart stress, hs-TnT, which shows heart muscle damage, hs-CRP, which measures inflammation, and RBP4, a protein that works with transthyretin. Additional blood tests will measure kidney function markers such as eGFR, creatinine, cystatin C, and UACR, as well as TSH, which checks thyroid function.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit and treatment switch

    At the start of the study, your current treatment with tafamidis will be stopped. Tafamidis is a medication you have been taking for at least the previous 3 months to treat your condition.

    You will begin taking acoramidis, which is the new medication being studied. Acoramidis is provided as 356 mg film-coated tablets that you will take by mouth.

    Blood samples will be collected to measure the baseline level of transthyretin in your blood. Transthyretin is a protein that your body produces, and its level is important for understanding how the treatment is working.

    Additional blood tests will be performed to measure NT-proBNP, hs-TnT, hs-CRP, and RBP4. These are markers that help assess your heart function and overall health.

    Blood tests will also check your kidney function by measuring eGFR, creatinine, cystatin C, and UACR. Your thyroid function will be assessed by measuring TSH.

    An echocardiogram will be performed. This is an ultrasound examination of your heart that allows doctors to see how your heart is functioning and to detect any structural changes.

    You will complete a 6-minute walk test. This test measures how far you can walk in 6 minutes and helps assess your physical capacity.

    You will be asked to complete two questionnaires: the KCCQ-OS, which assesses how your heart condition affects your daily life, and the EQ-5D-5L, which measures your overall quality of life.

  2. Step 2

    Week 1 visit

    One week after starting acoramidis, you will have a visit where blood samples will be collected to measure your transthyretin level.

    Any side effects or health changes you have experienced since starting the new medication will be recorded.

  3. Step 3

    Week 2 visit

    Two weeks after starting acoramidis, you will have another visit where blood samples will be collected to measure your transthyretin level.

    Any side effects or health changes you have experienced will be recorded.

  4. Step 4

    Week 3 visit

    Three weeks after starting acoramidis, you will have a visit where blood samples will be collected to measure your transthyretin level.

    Any side effects or health changes you have experienced will be recorded.

  5. Step 5

    Week 4 visit

    Four weeks after starting acoramidis, you will have a visit where blood samples will be collected to measure your transthyretin level.

    Any side effects or health changes you have experienced will be recorded.

  6. Step 6

    Month 3 visit

    Three months after starting acoramidis, you will have a visit where blood samples will be collected to measure your transthyretin level.

    Any side effects or health changes you have experienced will be recorded.

  7. Step 7

    Month 6 visit or early discontinuation

    Six months after starting acoramidis, you will have a final visit. If you stop taking the medication earlier than planned, this visit will occur at the time of discontinuation.

    Blood samples will be collected to measure your transthyretin level and compare it to the level measured at the beginning of the study.

    Blood tests will be repeated to measure NT-proBNP, hs-TnT, hs-CRP, and RBP4 to assess any changes from the start of the study.

    Blood tests will check your kidney function by measuring eGFR, creatinine, cystatin C, and UACR. Your thyroid function will be assessed by measuring TSH.

    An echocardiogram will be performed to evaluate any changes in your heart structure and function compared to the beginning of the study.

    You will complete another 6-minute walk test to assess any changes in your physical capacity.

    You will be asked to complete the KCCQ-OS and EQ-5D-5L questionnaires again to evaluate any changes in your quality of life.

    Any side effects or health changes you have experienced throughout the study will be recorded.

Who can join the trial?

6 criteria

  • You must be between 18 and 90 years old at the time you sign the consent form to join the study
  • You must have a confirmed diagnosis of ATTR-CM, which is a heart condition caused by abnormal protein deposits in the heart muscle. This diagnosis must have been confirmed by a special imaging scan called SPECT or SPECT/CT, or by a tissue sample called a biopsy, within the past 24 months
  • You must currently be taking a medicine called tafamidis and have been using it regularly for at least the past 3 months
  • Your heart failure symptoms must be mild, classified as NYHA class 2 or lower. This means you may have slight limitations in physical activity, but you feel comfortable at rest
  • Your kidney function must be adequate, with an eGFR of at least 30. The eGFR is a blood test that measures how well your kidneys are filtering waste from your blood
  • Your blood test for a protein called NT-proBNP must be greater than 300 but not more than 7000. This protein helps doctors understand how much strain your heart is under

Who cannot join the trial?

5 criteria

  • The study information does not list specific reasons why patients cannot participate in this clinical trial
  • If you are interested in this study, a doctor will need to review your complete medical history to determine if you are eligible to take part
  • General factors that often prevent participation in heart medication studies may include severe liver disease (when the liver is not working properly), severe kidney disease (when the kidneys cannot filter blood well), pregnancy or breastfeeding, or allergies to the study medications
  • You may not be able to join if you are taking certain other medications that could interact with the study drug
  • You may be excluded if you have other serious medical conditions that could affect your safety during the study
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Investigated drugs

  • Acoramidis

    is a medication being studied for the treatment of a heart condition caused by a buildup of abnormal protein deposits in the heart muscle. This condition is called transthyretin amyloidosis with cardiomyopathy. The study will look at how this medication affects the level of a specific protein in the blood called transthyretin in patients who were previously taking a different medication.

  • Tafamidis

    is a medication that patients in this study were taking before switching to acoramidis. It is used to treat the same heart condition caused by abnormal protein deposits. In this study, it serves as the previous treatment that patients were receiving before being changed to the new medication being tested.

What is already known about the treatment

  • Acoramidis

    Acoramidis is an investigational medication being studied in tablet or capsule form for the treatment of transthyretin amyloid cardiomyopathy, a rare heart condition where abnormal protein deposits damage the heart muscle. This drug works by binding to and stabilizing the transthyretin protein in the blood, preventing it from breaking apart and forming harmful deposits in the heart tissue. It belongs to a class of drugs called transthyretin stabilizers, and is currently being evaluated in clinical trials as an alternative treatment option for patients who were previously taking another similar medication called tafamidis.

  • Tafamidis

    Tafamidis is an approved oral medication available in capsule form used to treat transthyretin amyloid cardiomyopathy, a serious heart disease caused by abnormal protein buildup in the heart. The drug works by attaching to the transthyretin protein molecules in the bloodstream and keeping them stable, which prevents them from breaking down into smaller pieces that can form damaging deposits in heart tissue. As a transthyretin stabilizer, it is currently recognized in medical practice as a standard treatment option for this condition and is widely used to slow disease progression and improve patient outcomes.

Investigated diseases

Transthyretin Amyloid Cardiomyopathy – This is a disease where an abnormal protein called transthyretin builds up in the heart muscle. The protein deposits form clumps called amyloids that stiffen the heart walls and interfere with normal heart function. As the disease progresses, the heart becomes less able to pump blood effectively throughout the body. Patients typically experience increasing shortness of breath, fatigue, and swelling in the legs and ankles. The condition worsens over time as more amyloid protein accumulates in the heart tissue. This buildup can also affect the heart's electrical system, leading to irregular heartbeats.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521831-35-00Protocol code23026Estimated enrolment50 patientsSponsorBayer Consumer Care AG

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