At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 49 enrolled
Drug / intervention
AG10 +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 2, Randomized, Placebo-controlled, Dose-ranging Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AG10 in Patients With Symptomatic Transthyretin Amyloid Cardiomyopathy
In Brief
A Phase 2 clinical trial evaluating AG10 and Placebo Oral Tablet for Familial ATTR-CM (ATTRm-CM, or FAC) and Wild-type ATTR-CM (ATTRwt-CM). Completed, enrolled 49 participants across 13 sites.
Detailed Summary
This prospective, randomized, multicenter, double-blind, parallel group, placebo-controlled, dose-ranging study will evaluate the safety, tolerability, PK (Pharmacokinetic) and PD (Pharmacodynamic) of AG10 compared to placebo administered on a background of stable heart failure therapy. Screening and randomization will be followed by a 28-day blinded, placebo-controlled treatment period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMar 2018
Enrollment StartApr 2018
Primary CompletionOct 2018
TodayJul 2026
First PostedMar 8, 2018
Enrollment StartApr 27, 2018
Primary CompletionOct 5, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.3 years ago
Interventions
AG10drug
TTR stabilizer
Placebo Oral Tabletdrug
Nonactive control