At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 632 enrolled
Drug / intervention
acoramidis +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects With Symptomatic Transthyretin Amyloid Cardiomyopathy (ATTRibute-CM Trial)
In Brief
A Phase 3 clinical trial evaluating acoramidis and Placebo Oral Tablet for Amyloidosis and 4 related conditions. Completed, enrolled 632 participants across 104 sites in 18 countries.
Detailed Summary
Phase 3 efficacy and safety study to evaluate acoramidis (AG10) HCl 800 mg administered orally twice a day compared to placebo in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyloidosis, Amyloid Cardiomyopathy, Transthyretin Amyloidosis, Cardiomyopathies, Heart Diseases
CountriesAustralia, Belgium, Brazil, Canada, Czechia, Denmark, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, South Korea, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMar 2019
Enrollment StartMar 2019
Primary CompletionMay 2023
TodayJul 2026
First PostedMar 4, 2019
Enrollment StartMar 19, 2019
Primary CompletionMay 11, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.3 years ago
Interventions
acoramidisdrug
TTR stabilizer administered orally twice daily (BID)
Placebo Oral Tabletdrug
Non-active control administered orally twice daily (BID)