A Phase 4 interventional study of Acoramidis (AG10) oral tablet in Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM), Amyloidosis and Amyloid Cardiomyopathy, sponsored by Eidos Therapeutics, a BridgeBio company. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Eidos Therapeutics, a BridgeBio company (part of BridgeBio) · Phase 4, Interventional, and Treatment
The study aims to evaluate the effect of acoramidis on cardiac functional and structural improvement in participants with ATTR-CM.
Study AG10-404 is an open-label study to investigate the long-term effects of acoramidis on cardiac functional and structural improvement, and the effects on cardiac amyloid burden in participants with ATTR-CM using two types of imaging, cardiac MRI and echocardiograms to track changes in heart structure and amyloid buildup over time.
Up to approximately 150 participants (ages 18-80) will be enrolled. Participants will receive study drug (712 mg equivalent to 800 mg of acoramidis hydrochloride) orally twice daily from Day 1 through Month 36. The study duration for an individual participant is approximately 38 months, including up to 45 days for screening, 36 months for open-label treatment and 1 month follow-up after the last dose of study drug. In-clinic visits will occur at Day 1, Day 28, Month 6, and every 6 months up to Month 36. Phone visits will occur at Month 3 and every 6 months thereafter up to Month 33. Participants will be followed throughout their participation in this study and for 30 days (+7 days) after the last dose of study drug.
82 studies on the registry are indexed under Amyloidosis, Hereditary, Transthyretin-Related; 28 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 36 interventional studies indexed under Amyloidosis, Hereditary, Transthyretin-Related.
Browse Amyloidosis, Hereditary, Transthyretin-Related studies →Eidos Therapeutics, a BridgeBio company is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
First submitted after Eidos Therapeutics became part of BridgeBio.
Compared within Amyloidosis, Hereditary, Transthyretin-Related, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Amyloidosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Open-label study where all participants will receive acoramidis (AG10) during the study
Drug: Acoramidis (AG10) oral tablet
Study drug is defined as acoramidis 712 mg (equivalent to 800 mg acoramidis hydrochloride) taken orally twice daily for 36 months of open label treatment.
To assess the effect of acoramidis on cardiac function improvement by CMR in participants with ATTR-CM.
Change from baseline in left ventricular ejection fraction (LVEF) or left ventricular stroke volume index (LVSVi) at Month 36.
Time frame: Month 36
To assess the effect of acoramidis on cardiac function improvement or stabilization by CMR in participants with ATTR-CM.
Change from baseline in LVEF and LVSVi at Month 36
Time frame: Month 36
To assess the effect of acoramidis on cardiac function stabilization by CMR in participants with ATTR-CM.
Change from baseline in LVEF and LVSVi at Month 36
Time frame: Month 36
To evaluate the effect of treatment with acoramidis on individual parameters of left ventricular systolic function by CMR in participants with ATTR-CM
Mean change from baseline in LVEF, LVSVi, left ventricular global longitudinal strain (LVGLS) at Month 36
Time frame: Month 36
To evaluate the effect of acoramidis on cardiac structure by CMR in participants with ATTR-CM
Mean change from baseline in left ventricular mass index (LVMi) at Month 36
Time frame: Month 36
To evaluate the effect of treatment with acoramidis on cardiac amyloid burden by CMR in participants with ATTR-CM
Mean change from baseline in extracellular volume (ECV) at Month 36
Time frame: Month 36
Exploratory Outcome Measure
To evaluate the effect of acoramidis on various biomarkers and cardiac transthoracic echocardiogram
Time frame: At Month 12, 24 and 36
Plan to share: Undecided
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Studies of the drug tested here: Acoramidis
Amyloidosis, Hereditary, Transthyretin-Related →
Eidos Therapeutics, a BridgeBio company →