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

Sponsor
Eidos Therapeutics, a BridgeBio company
Study ID
NCT07116473
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Nov 30, 2025
Status verified
Aug 2025
Primary completion
Nov 30, 2037
Completion
Dec 31, 2037

Study Design

Enrollment
250 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Acoramidis
    Participants will receive acoramidis 712 mg orally BID (which is equivalent to 800 mg acoramidis HCl BID)

Primary Outcome Measure

To evaluate the long-term safety and tolerability of acoramidis in participants with newly diagnosed ATTR-CM [ Time Frame: The duration of study participation for the participants will be up to 5 years. ]

Central Contacts

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