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NCT07298044From ClinicalTrials.govRecruiting

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 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 Amyloid Cardiomyopathy

At a glance

Phase
Phase 4
Study type
Interventional
Sponsor
Bayer
Enrolment target
50
Started
13 February 2026
Main results due
15 July 2027
Study sites
26
Registry updated
25 September 2026

Can you take part?

  • Ages 18 years to 90 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

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.

Study sites(26)

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

    Sankt Pölten, Lower Austria, Austria

    Withdrawn

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

    Vienna, State of Vienna, Austria

    Recruiting

  • Klinik Favoriten - 5.Medizinische Abteilung-Kardiologie

    Vienna, State of Vienna, Austria

    Recruiting

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

    Vienna, State of Vienna, Austria

    Not yet recruiting

  • Medizinische Universität Graz- Klinische Abteilung für Kardiologie

    Vienna, Styria, Austria

    Recruiting

  • Krankenhaus St. Josef Braunau | Innere Medizin I

    Braunau am Inn, Upper Austria, Austria

    Recruiting

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

    Feldkirch, Vorarlberg, Austria

    Withdrawn

  • Hôpital Erasme/Erasmus Ziekenhuis

    Brussels, Brussels Capital, Belgium

    Not yet recruiting

  • AZ St-Jan Brugge-Oostende A.V.

    Bruges, West Flanders, Belgium

    Not yet recruiting

  • Universitaetsklinikum Ulm | Klinik fuer Innere Medizin II

    Ulm, Baden-Wurttemberg, Germany

    Withdrawn

  • KVZ Kardiovaskulaeres Zentrum Darmstadt GmbH

    Darmstadt, Hesse, Germany

    Not yet recruiting

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

    Greifswald, Mecklenburg-Vorpommern, Germany

    Withdrawn

  • Universitätsklinikum Bonn - Herzzentrum des Universitätsklinikums Bonn

    Bonn, North Rhine-Westphalia, Germany

    Withdrawn

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

    Berlin, Germany

    Withdrawn

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

    Hamburg, Germany

    Withdrawn

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Cardiologia 1

    Bergamo, Italy

    Recruiting

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola_Cardiologia

    Bologna, Italy

    Not yet recruiting

  • Careggi University Hospital_cardio intensive care unit

    Florence, Italy

    Not yet recruiting

  • Ospedale Vito Fazzi Lecce_Cardiologia e UTIC

    Lecce, Italy

    Not yet recruiting

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

    Milan, Italy

    Recruiting

  • Azienda Ospedaliera Dei Colli_Monaldi - Malattie Rare e Genetiche Cardiovascolari

    Naples, Italy

    Not yet recruiting

  • Azienda Ospedale-Università di Padova-UOC Cardiologia

    Padova, Italy

    Recruiting

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

    Pavia, Italy

    Not yet recruiting

  • Fondazione Toscana Gabriele Monasterio_Pisa - Cardiologia e Medicina Cardiovascolare

    Pisa, Italy

    Recruiting

  • Azienda Ospedaliera Universitaria Senese - cardiologia

    Siena, Italy

    Recruiting

  • Oslo Universitetssykehus HF, Rikshospitalet

    Oslo, Norway

    Not yet recruiting

Showing 26 of 26 sites. 9 of the 26 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07298044. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study to Learn More About the Change in the Blood Levels of Transthyretin When Participants With Transthyret | Trialion