Long-term study of acoramidis in people newly diagnosed with ATTR heart disease
Tests acoramidis over the long term in adults newly diagnosed with transthyretin amyloid heart disease.
Plain-language title generated from the registry record
Registry title: To Evaluate the Long-term Safety and Tolerability of Acoramidis in Participants With Newly Diagnosed ATTR-CM (ACT-EARLY OLE)
Key facts
- Where
- Leuven, BelgiumSee the site
- Phase
- Phase 3
Where in Belgium
- UZ LeuvenLeuven, BelgiumNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eidos Therapeutics, a BridgeBio company
- Trial code
- NCT07116473EU 2024-513676-18-00
- Record updated
- 11 August 2026
- Original description
The AG10-504 study is an open-label extension study of acoramidis in participants with newly diagnosed transthyretin amyloid cardiomyopathy (ATTR-CM) or both ATTR-CM and transthyretin amyloid polyneuropathy (ATTR-PN).Read full original descriptionShow less
A Phase 3, Open-Label, Multicenter, Extension Study of Acoramidis in Patients With Newly Diagnosed Variant Transthyretin Amyloid Cardiomyopathy (ACT-EARLY OLE)
The AG10-504 study is an open-label extension study of acoramidis in participants with newly diagnosed transthyretin amyloid cardiomyopathy (ATTR-CM) or both ATTR-CM and transthyretin amyloid polyneuropathy (ATTR-PN).
Inclusion: Participants must have completed the AG10-501 study (ACT-EARLY study) within the past 60 calendar days with a diagnosis of ATTR-CM (based on the AG10-501 protocol definition of ATTR-CM).
Exclusion: Participants who completed the AG10-501 study with a diagnosis of ATTR-PN only or who permanently discontinued study drug prior to diagnosis of ATTR-CM in AG10-501; Major surgery planned during the next 6 months (some exceptions); History of light-chain amyloidosis (AL) or another non-TTR amyloid subtype (eg, ApoA-1, gelsolin); Stage IV or V chronic kidney disease; Active malignancy, except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix that has been successfully treated; History of any organ transplant (with the exception of corneal transplant); Known hypersensitivity to acoramidis or any of its excipients; History of a monoclonal paraprotein or abnormal light chains in serum or urine (ie, monoclonal gammopathy of undetermined significance, MGUS) in which AL has not been ruled out; Treatment of ATTR-CM with any ATTR-oriented on- or off-label or OTC product.