Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug may boost protein levels in heart disease patients

NCT ID NCT07298044

Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 5 times

Summary

This study tests whether switching from tafamidis to acoramidis can raise blood levels of transthyretin (TTR) in adults with transthyretin amyloid cardiomyopathy (ATTR-CM). The drug acoramidis stabilizes TTR to prevent harmful amyloid clumps that stiffen the heart. Researchers will measure TTR levels over 6 months in 50 participants who have already been on tafamidis. The goal is to see if acoramidis works better at keeping TTR stable.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
acoramidis (a drug that stabilizes the TTR protein to prevent amyloid buildup)
What this could lead to
If successful, this study could show that acoramidis raises TTR levels more than tafamidis, potentially offering a better option for managing ATTR-CM.
What could go wrong
This is a small, early-phase study with only 50 participants and no placebo group. It measures a lab marker (TTR level), not long-term heart outcomes, so benefits are uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Transthyretin amyloid cardiomyopathy are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

wild type ATTR amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Transthyretin amyloid cardiomyopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ St-Jan Brugge-Oostende A.V.

    NOT_YET_RECRUITING

    Bruges, West Flanders, 8000, Belgium

  • Azienda Ospedale-Università di Padova-UOC Cardiologia

    RECRUITING

    Padova, 35128, Italy

  • Azienda Ospedaliera Dei Colli_Monaldi - Malattie Rare e Genetiche Cardiovascolari

    NOT_YET_RECRUITING

    Naples, 80131, Italy

  • Azienda Ospedaliera Universitaria Senese - cardiologia

    RECRUITING

    Siena, 53100, Italy

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola_Cardiologia

    NOT_YET_RECRUITING

    Bologna, 40138, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Cardiologia 1

    RECRUITING

    Bergamo, 24127, Italy

  • Careggi University Hospital_cardio intensive care unit

    NOT_YET_RECRUITING

    Florence, 50134, Italy

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

    RECRUITING

    Milan, 20138, Italy

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

    NOT_YET_RECRUITING

    Pavia, 27100, Italy

  • Fondazione Toscana Gabriele Monasterio_Pisa - Cardiologia e Medicina Cardiovascolare

    RECRUITING

    Pisa, 56124, Italy

  • Hôpital Erasme/Erasmus Ziekenhuis

    NOT_YET_RECRUITING

    Brussels, Brussels Capital, 1070, Belgium

  • KVZ Kardiovaskulaeres Zentrum Darmstadt GmbH

    NOT_YET_RECRUITING

    Darmstadt, Hesse, 64287, Germany

  • Klinik Favoriten - 5.Medizinische Abteilung-Kardiologie

    RECRUITING

    Vienna, State of Vienna, 1100, Austria

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

    NOT_YET_RECRUITING

    Vienna, State of Vienna, 3500, Austria

  • Krankenhaus St. Josef Braunau | Innere Medizin I

    RECRUITING

    Braunau am Inn, Upper Austria, 5280, Austria

  • Medizinische Universität Graz- Klinische Abteilung für Kardiologie

    RECRUITING

    Vienna, Styria, 1030, Austria

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

    RECRUITING

    Vienna, State of Vienna, 1090, Austria

  • Oslo Universitetssykehus HF, Rikshospitalet

    NOT_YET_RECRUITING

    Oslo, 0424, Norway

  • Ospedale Vito Fazzi Lecce_Cardiologia e UTIC

    NOT_YET_RECRUITING

    Lecce, 73100, Italy

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

    WITHDRAWN

    Berlin, 10365, Germany

  • Universitaetsklinikum Ulm | Klinik fuer Innere Medizin II

    WITHDRAWN

    Ulm, Baden-Wurttemberg, 89081, Germany

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

    WITHDRAWN

    Greifswald, Mecklenburg-Vorpommern, 17475, Germany

  • Universitätsklinikum Bonn - Herzzentrum des Universitätsklinikums Bonn

    WITHDRAWN

    Bonn, North Rhine-Westphalia, 53127, Germany

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

    WITHDRAWN

    Hamburg, 20246, Germany

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

    WITHDRAWN

    Sankt Pölten, Lower Austria, 1210, Austria

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

    WITHDRAWN

    Feldkirch, Vorarlberg, 6800, Austria

More trials for these conditions

Other studies related to the condition(s) this trial covers.