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

StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Nov 2025 to Nov 2026 Eligibility criteria shortened, about 57 words · Study description expanded, about 19 wordsv2 Show 2 more changesShow less
    • Eligibility criteria shortened, about 57 words
    • Study description expanded, about 19 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07116473
Lead Sponsor Eidos Therapeutics, a BridgeBio company
Conditions Amyloidosis in Transthyretin (TTR), Amyloidosis, Familial, Amyloid Cardiomyopathy, Amyloid Cardiomyopathy, Transthyretin-Related, Amyloidogenic Transthyretin (ATTR) Amyloidosis, Heart Disease, Cardiomyopathies, Amyloidosis, Hereditary, Transthyretin-Related +2 more
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov