To Evaluate the Long-term Safety and Tolerability of Acoramidis in Participants With Newly Diagnosed ATTR-CM (ACT-EARLY OLE)

ConditionsAmyloidosis in Transthyretin (TTR)Amyloidosis, Familial Amyloid Cardiomyopathy Amyloid Cardiomyopathy, Transthyretin-Related Amyloidogenic Transthyretin (ATTR) Amyloidosis Heart Disease Cardiomyopathies Amyloidosis, Hereditary, Transthyretin-Related Polyneuropathies Amyloidosis

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorEidos Therapeutics, a BridgeBio company

About this trial

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).

Eligibility criteria

Qualifiers

None

Disqualifiers

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.

History of AL or another non-TTR amyloid subtype (eg, ApoA-1, gelsolin).

History of a monoclonal paraprotein or abnormal light chains in serum or urine (i.e., MGUS) in which AL has not been ruled out.

Stage IV or V chronic kidney disease (corresponding to an eGFR ≤ 29 mL/min/1.73 m2), or undergoing renal dialysis, or recipient of a kidney transplant.

Trial design

Treatments tested in this trial

Acoramidis (AG10)

Treatment groups

250 Participants

are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Eidos Therapeutics, a BridgeBio company

Lead sponsor

Source ClinicalTrials.gov