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Transthyretin Amyloid CardiomyopathyPhase 4ACO-SWITCHNCT07298044

A Study to Learn More About the Change in the Blood Levels of Transthyretin When Participants With Transthyretin Amyloidosis With Cardiomyopathy Switch From Tafamidis to Acoramidis

A Phase 4 study testing Acoramidis in people with Transthyretin Amyloid Cardiomyopathy, run by Bayer at 26 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Transthyretin (TTR) is a protein made by the liver that helps transport thyroid hormone and vitamin A in the blood. In some people, this protein breaks down and forms harmful clumps called amyloid. TTR amyloid gets deposited in the heart wall and stops it from pumping blood properly, which may lead to heart failure. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Transthyretin Amyloid Cardiomyopathy
What is being tested?
Acoramidis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
26 sitesin 5 countries
Study dates
13 Feb 2026to 15 Jul 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must be 18 to 90 years of age inclusive, at the time of signing the informed consent.
  • Diagnosis of ATTR-CM; disease defining examination, i.e., Single Photon Emission Computed Tomography (SPECT) or SPECT/Computed Tomography (CT) or biopsy, within 24 months prior to Visit 1 (V1).
  • Participants must currently be treated with tafamidis and have used tafamidis for at least the previous 3 months prior to V1 and have adhered to tafamidis therapy.
  • New York Heart Association (NYHA) class ≤ II at V1.
  • Estimate glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m^2 at V1.
  • N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) > 300 and ≤ 7000 pg/mL at V1.

Who cannot join

  • Prior liver or heart transplantation or planned within the next 12 months.
  • Current or planned use of ventricular assist device.
  • Active cancer or other disease that decreases the life expectancy to less than one year.
  • Heart failure due to ischemic heart disease.
  • Myocardial infarction, cardiovascular (CV) surgery, or unstable angina within the last 90 days prior to V1.
  • Confirmed diagnosis of light-chain amyloidosis.
Show all 16Show fewer
  • Dialysis or severe renal impairment as reflected by Urinary Albumin Creatinine Ratio (UACR) > 300 mg/g at V1.
  • Major surgery within 90 days prior to V1.
  • Recent initiation of Sodium-Glucose-Cotransporter-2 inhibitors (SGLT2i) within 3 months before V1.
  • Initiation of treatment with a diuretic or increase in diuretic dose within 3 months before V1.
  • Treatment with calcium channel blockers (e.g., verapamil, diltiazem) or digitalis.
  • Recent CV hospitalization within 3 months before V1.
  • Known hypersensitivity to acoramidis or to any of the excipients.
  • A condition that, as judged by the investigator, would preclude compliance with the study protocol, such as a history of substance abuse, alcoholism, or a psychiatric condition.
  • Known or suspected liver disorder and bile secretion/flow (cholestasis, also history of it).
  • Abnormal liver function tests at V1, defined as ALT (GPT) or AST (GOT) ≥ 3 x ULN or total bilirubin ≥ 3 x ULN at V1.

Trial locations and contacts

26 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Bayer Clinical Trials Contact contact

18888422937

clinical-trials-contact@bayer.com

26 sites in 5 countries

Italy10 sites, 10 recruiting

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Cardiologia 1

    Bergamo, Lombardy, 24127

    Recruiting

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola_Cardiologia

    Bologna, Emilia-Romagna, 40138

    Not yet recruiting

  • Careggi University Hospital_cardio intensive care unit

    Florence, Tuscany, 50134

    Recruiting

  • Ospedale Vito Fazzi Lecce_Cardiologia e UTIC

    Lecce, Apulia, 73100

    Not yet recruiting

  • Centro Cardiologico Monzino S.p.A. - Cardiologia Peri-Operatoria e Imaging Cardiovascolare

    Milan, Lombardy, 20138

    Recruiting

  • Azienda Ospedaliera Dei Colli_Monaldi - Malattie Rare e Genetiche Cardiovascolari

    Naples, 80131

    Not yet recruiting

  • Azienda Ospedale-Università di Padova-UOC Cardiologia

    Padova, Veneto, 35128

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo-SC Medicina Generale 2 - Centro Amiloidosi Sistemiche e Malattie ad Alta Complessità

    Pavia, Lombardy, 27100

    Not yet recruiting

  • Fondazione Toscana Gabriele Monasterio_Pisa - Cardiologia e Medicina Cardiovascolare

    Pisa, Tuscany, 56124

    Recruiting

  • Azienda Ospedaliera Universitaria Senese - cardiologia

    Siena, Tuscany, 53100

    Recruiting

Other trials in Italy

Austria7 sites, 5 recruiting

  • Krankenhaus St. Josef Braunau | Innere Medizin I

    Braunau am Inn, Upper Austria, 5280

    Recruiting

  • VIVIT - Landeskrankenhaus Feldkirch - Innere Medizin I, Kardiologie, Angiologie, Endokrinologie, Diabetologie, Intensivmedizin

    Feldkirch, Vorarlberg, 6800

    Withdrawn

  • Universitätsklinikum St. Pölten - Lilienfeld - Klinische Abteilung für Innere Medizin 3

    Sankt Pölten, Lower Austria, 1210

    Withdrawn

  • Medizinische Universität Wien- Universitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie

    Vienna, State of Vienna, 1090

    Recruiting

  • Klinik Favoriten - 5.Medizinische Abteilung-Kardiologie

    Vienna, State of Vienna, 1100

    Recruiting

  • Klinik Ottakring - 3. Medizinische Abteilung mit Kardiologie, internistischer Intensivmedizin und Ambulanz

    Vienna, State of Vienna, 3500

    Not yet recruiting

  • Medizinische Universität Graz- Klinische Abteilung für Kardiologie

    Vienna, Styria, 1030

    Recruiting

Other trials in Austria

Germany6 sites, 1 recruiting

  • Sana Klinikum Lichtenberg - Klinik für Innere Medizin II, Schwerpunkt Kardiologie

    Berlin, 10365

    Withdrawn

  • Universitätsklinikum Bonn - Herzzentrum des Universitätsklinikums Bonn

    Bonn, North Rhine-Westphalia, 53127

    Withdrawn

  • KVZ Kardiovaskulaeres Zentrum Darmstadt GmbH

    Darmstadt, Hesse, 64287

    Not yet recruiting

  • Universitaetsmedizin Greifswald KöR- Klinik und Poliklinik für Innere Medizin B

    Greifswald, Mecklenburg-Vorpommern, 17475

    Withdrawn

  • Universitätsklinikum Hamburg Eppendorf (UKE)-Universitären Herz- und Gefäßzentrum Hamburg, Klinik für Kardiologie

    Hamburg, 20246

    Withdrawn

  • Universitaetsklinikum Ulm | Klinik fuer Innere Medizin II

    Ulm, Baden-Wurttemberg, 89081

    Withdrawn

Other trials in Germany

Belgium2 sites, 2 recruiting

  • AZ St-Jan Brugge-Oostende A.V.

    Bruges, West Flanders, 8000

    Not yet recruiting

  • Hôpital Erasme/Erasmus Ziekenhuis

    Brussels, Brussels Capital, 1070

    Not yet recruiting

Other trials in Belgium

Norway1 site, 1 recruiting

  • Oslo Universitetssykehus HF, Rikshospitalet

    Oslo, 0424

    Not yet recruiting

Other trials in Norway

About this study

Official title: A Prospective, Single-arm, Phase 4 Study to Evaluate the Course of Serum Transthyretin (TTR) Level With Acoramidis in Adult Patients With Variant or Wild-type Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM) Previously Treated With Tafamidis

Transthyretin (TTR) is a protein made by the liver that helps transport thyroid hormone and vitamin A in the blood. In some people, this protein breaks down and forms harmful clumps called amyloid. TTR amyloid gets deposited in the heart wall and stops it from pumping blood properly, which may lead to heart failure. The breakage in TTR protein can be age-related (wild-type ATTR-CM), or genetic (variant ATTR-CM).

The study drug, acoramidis, works by attaching itself to the TTR protein, making TTR more stable and less likely to break down and form amyloid (clumps). This helps to slow down the progression of the disease, improve heart function, and increase the TTR levels in the blood. Acoramidis is an approved treatment for wild-type or variant ATTR-CM in Europe and the United States.

Read more

Tafamidis is another drug that stabilizes TTR and prevents it from breaking down.

In this study, acoramidis will be studied in participants with ATTR--CM who were previously treated with tafamidis. The main purpose of this study is to assess the change in blood TTR levels after participants are switched from tafamidis to acoramidis. This will be studied to understand if acoramidis causes an increase in blood TTR levels beyond the levels achieved with tafamidis.

For this, the researchers will measure the change in the levels of TTR protein in participants' blood after 6 months of the treatment with acoramidis, or earlier if a participant stops the treatment before reaching that six-month mark.

All participants will continue taking tafamidis during the screening period. In the treatment period of the study, participants will take acoramidis as two tablets twice daily by mouth, for up to 6 months.

At the start of this study, the study doctors will review each participant's medical history and check their overall health. The study doctors will perform electrocardiograms (ECG), and measure blood pressure and heart rate. Researchers will also take blood and urine samples from the participants to measure levels of TTr, NT-proBNP, hs-TnT, hs-CRP, RBP4, eGFR, creatinine, cystatin-C, UACR, and TSH at the start of the study, and at various time points thereafter (during the study) to assess heart, kidney and thyroid function.

There will be a total of 9 study check-ins. Participants will visit the study site twice: at screening and at the end of treatment period. A study nurse will visit the participant's home 6 times, at the start of treatment, Weeks 1, 2, 3 and 4, then again at 3 months. The final check-in will be done by phone.

The study doctors will monitor the health of the participants regularly for any medical problems during follow-up visits. Participants will know the treatment they will receive during the study. Each participant could be in the study for about 8 months.

Being tested
Acoramidis
Keywords
ATTR-CM

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcoramidisDrug

    Also called BAY3684938, BEYONTTRA

    356 mg film-coated tablets.

    The recommended dose of acoramidis is 712 mg (two tablets, 356 mg) orally, twice daily, corresponding to a total daily dose of 1424 mg.

Study groups in NCT07298044
Study groupRoleWhat they receive
AcoramidisExperimentalParticipants will receive acoramidis 712 mg orally BID
Receives: Drug: Acoramidis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in serum TTR level from baseline to month 6 or premature discontinuation of treatment

    TTR = Transthyretin

    Measured: From baseline to month 6 or premature discontinuation of treatment

Secondary outcomes (14)

  1. Change in serum TTR level from baseline to week 1, 2, 3, 4 and at month 3.

    TTR = Transthyretin

    Measured: At baseline, week 1, 2, 3, 4 and at month 3

  2. Number of participants with TEAEs and serious TEAEs

    Measured: From the first administration of study drug until 30 days after the last dose of study drug or end of study, whatever occurs first

  3. Change from baseline to month 6 of NT-proBNP

    NT-proBNP = N-terminal pro-B-type Natriuretic Peptide

    Measured: From baseline to month 6

  4. Change from baseline to month 6 of hs-TnT

    hs-TNT = high-sensitivity Troponin T

    Measured: From baseline to month 6

  5. Change from baseline to month 6 of RBP4

    RBP4 = Retinol Binding Protein 4

    Measured: From baseline to month 6

  6. Signs of cardiac remodeling from baseline to month 6

    These signs will be measured by echocardiogram

    Measured: From baseline to month 6

  7. Change from baseline to month 6 in 6MWD

    The 6-Minute Walk distance (6MWD) measures the total distance that a participant could walk in 6 minutes.

    Measured: From baseline to month 6

  8. Change from baseline to month 6 in the eGFR

    eGFR = estimated glomerular filtration rate

    Measured: From baseline to month 6

  9. Change from baseline to month 6 in Creatinine

    Measured: From baseline to month 6

  10. Change from baseline to month 6 in Cystatin C

    Measured: From baseline to month 6

  11. Change from baseline to month 6 in UACR

    UACR = Urinary Albumin Creatinine Ratio

    Measured: From baseline to month 6

  12. Change from baseline to month 6 in TSH

    TSH = Thyroid Stimulating Hormone

    Measured: From baseline to month 6

  13. Change from baseline to month 6 in KCCQ-OS score

    The Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS) is 23-item questionnaire developed to measure health status and health-related quality of life (QoL) in individuals with heart failure. Items include heart failure symptoms, impact on physical and social functions, and how heart failure impacts QoL.

    Measured: From baseline to month 6

  14. Change from baseline to month 6 of EQ-5D-5L index score

    The EuroQol-5-Dimension-5-Level (EQ-5D-5L) includes two parts. In the first part, participants are asked to rate their current health state on 5 dimensions (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having five levels of function (1-no problem, 2-slight problem, 3-moderate problem, 4-severe problem, and 5-extreme problem). The second part is a self-rating of current health status on a Visual Analogue Scale (EQ VAS) with endpoints labeled "best imaginable health state" (score of 100) and "worst imaginable health state" (score of 0). The scores from the 5 dimensions are used to calculate the index score.

    Measured: From baseline to month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2025
  2. Study start13 Feb 2026
  3. Primary completion15 Jul 2027 (estimated)
  4. Study completion15 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07298044
Sponsor's protocol ID
23026
Other IDs
2025-521831-35-00, 2025
Acronym
ACO-SWITCH
Status last verified
24 Sep 2026
First submitted
11 Dec 2025
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.

Publications

  • Pfister R, Michel L, Schulze M, Vogtlander K, Ciaccia A, Merz M, Hengstenberg C. ACO-SWITCH: Rationale and Design of a Phase 4 Study Evaluating Serum Transthyretin in ATTR-CM After Switching from Tafamidis to Acoramidis. Cardiol Ther. 2026 Aug 20. doi: 10.1007/s40119-026-00466-4. Online ahead of print.

    PubMed 42622768

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Acoramidis in people with Transthyretin Amyloid Cardiomyopathy, run by Bayer at 26 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Italy, Austria, Germany, Belgium, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bayer Clinical Trials Contact (18888422937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum TTR level from baseline to month 6 or premature discontinuation of treatment (time frame: From baseline to month 6 or premature discontinuation of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07298044, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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