NCT07116473 · Phase 3 · NOT YET RECRUITING
To Evaluate the Long-term Safety and Tolerability of Acoramidis in Participants With Newly Diagnosed ATTR-CM (ACT-EARLY OLE)
This trial follows people who already finished an earlier study of acoramidis, a drug taken by mouth. It tracks long-term safety and tolerability in people newly diagnosed with transthyretin amyloid cardiomyopathy, a heart condition. It is a Phase 3 open-label extension: everyone gets the drug, and researchers watch for side effects over time.
Eligibility criteria
Key Inclusion Criteria: 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). Key Exclusion Criteria: 1. 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. 2. History of light-chain amyloidosis (AL) or another non-TTR amyloid subtype (eg, ApoA-1, gelsolin). 3. 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. 4. Stage IV or V chronic kidney disease. 5. Active malignancy, except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix that has been successfully treated. 6. History of any organ transplant (with the exception of corneal transplant). 7. Known hypersensitivity to acoramidis or any of its excipients. 8. Major surgery planned during the next 6 months (some exceptions). 9. Treatment of ATTR-CM with any ATTR-oriented on- or off-label or OTC product.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-08-11