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
- Aarhus N, DenmarkSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people who finished the earlier ACT-EARLY study (AG10-501) in the last 60 days with newly diagnosed ATTR-CM, a heart disease caused by transthyretin amyloid. All take acoramidis.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- ATTR-CM diagnosed in the AG10-501 study. People with ATTR-PN only cannot join.
- Earlier treatment
- Must have completed the AG10-501 (ACT-EARLY) study within the past 60 calendar days. Must not be treated for ATTR-CM with any other ATTR-oriented product.
Main reasons for not taking part
- Completed AG10-501 with ATTR-PN only, or stopped study drug before ATTR-CM was diagnosed
- History of light-chain amyloidosis (AL) or another non-TTR amyloid type
- Stage IV or V chronic kidney disease
- Active cancer (except some treated skin or cervical cancers)
- Any organ transplant (except corneal transplant)
Read by machine on 12 November 2026.
Where in Denmark
- Region MidtjyllandAarhus N, DenmarkNot 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.