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ACO-SWITCHAcoramidis Impact on Serum Transthyretin Levels in ATTR-CM Patients Previously Treated with Tafamidis

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Study Aim

This study aims to evaluate the impact of Acoramidis on serum Transthyretin levels in patients previously treated with Tafamidis for ATTR-CM, measuring changes from the start of the study up to the sixth month or premature end of treatment.

What is being tested

Acoramidis

Drug
Who is being recruted

From 18 to 90 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: February 2026
See protocol details

Summary

Principal SponsorBayer
Study ContactBayer Clinical Trials Contact
Last updated: February 12, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 13, 2026

Actual date on which the first participant was enrolled.

This study focuses on a condition called Transthyretin Amyloidosis with Cardiomyopathy (ATTR-CM), where a protein called Transthyretin (TTR) breaks down and forms harmful clumps in the heart, affecting its ability to pump blood effectively. This can be due to aging (wild-type ATTR-CM) or genetics (variant ATTR-CM). The study uses a drug called acoramidis, which helps stabilize the TTR protein to prevent it from breaking down and forming these clumps. The main goal of this research is to understand how switching from another similar drug, tafamidis, to acoramidis affects the levels of TTR in the blood of adults with ATTR-CM who were previously treated with tafamidis. During the study, participants will continue taking tafamidis during the screening period, and then switch to acoramidis, taking two tablets twice daily by mouth for up to 6 months. The change in TTR protein levels in the blood will be measured after 6 months of treatment with acoramidis, or earlier if a participant stops the treatment before reaching that point. Participants will have regular check-ups, including heart function tests, blood and urine samples, and health monitoring. The study involves 9 check-ins, with 2 visits to the study site, 6 home visits by a study nurse, and a final check-in by phone. Each participant may be involved in the study for about 8 months.

Official TitleA 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
Principal SponsorBayer
Study ContactBayer Clinical Trials Contact
Last updated: February 12, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
New York Heart Association (NYHA) class ≤ II at V1.

N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) > 300 and ≤ 7000 pg/mL at V1.

Estimate glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m^2 at V1.

Participants must be 18 to 90 years of age inclusive, at the time of signing the informed consent.

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16 exclusion criteria prevent from participating
Initiation of treatment with a diuretic or increase in diuretic dose within 3 months before V1.

Recent initiation of Sodium-Glucose-Cotransporter-2 inhibitors (SGLT2i) within 3 months before V1.

Major surgery 90 days prior to V1.

Known or suspected liver disorder and bile secretion/flow (cholestasis, also history of it).

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive acoramidis 712 mg orally BID

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

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

Sankt Pölten, AustriaOpen Universitätsklinikum St. Pölten - Lilienfeld - Klinische Abteilung für Innere Medizin 3 in Google Maps
Suspended

Medizinische Universität Graz- Klinische Abteilung für Kardiologie

Vienna, Austria
Suspended

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

Vienna, Austria
Suspended

Klinik Favoriten - 5.Medizinische Abteilung-Kardiologie

Vienna, Austria
Recruiting soon5 Study Centers