Acoramidis Study for Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

This study is looking at how a drug called acoramidis affects people with Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM), a condition where abnormal protein buildup affects the heart. Researchers want to see if acoramidis can improve heart function. You might be able to join if you are 18-80 years old, have a confirmed ATTR-CM diagnosis requiring targeted therapy, and meet certain heart health criteria, including a specific heart pumping ability (left ventricular ejection fraction or LVEF >35%). The study will measure changes in your heart function using imaging tests like cardiac MRI over 36 months. This study is currently unclear on its recruitment status and plans to enroll about 150 participants.

Study design
This is an open-label study, meaning both you and the study team will know you are receiving acoramidis. It aims to enroll about 150 participants.
What's involved
You would take acoramidis orally twice daily for 36 months. You'll have in-clinic visits at Day 1, Day 28, Month 6, and every 6 months up to Month 36, plus phone visits at Month 3 and every 6 months up to Month 33.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 30 days (+7 days) after your last dose of acoramidis.

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NCT07695701

Cardiac Magnetic Resonance and Echocardiography Study With Acoramidis

Recruiting
PHASE4Ages 18–80InterventionalTreatment
Eidos Therapeutics, a BridgeBio company
~150 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Acoramidis (AG10) oral tablet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the effect of acoramidis on cardiac function improvement by CMR in participants with ATTR-CM.
Measured over Month 36
Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
Amyloidosis
Amyloid Cardiomyopathy
Transthyretin Amyloidosis
1 sites across 1 states
Missouri1

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Eligibility criteria

Inclusion

Participants aged 18 to 80
Confirmed diagnosis of ATTR-CM requiring targeted therapy
At screening: New York Heart Association (NYHA) Class I/II; estimated glomerular filtration rate (eGFR) ≥40 mL/min/1.73m2; left ventricular ejection fraction (LVEF) \>35%; left ventricular (LV) wall thickness ≥12 mm.
Heart failure condition has been clinically stable for at least 6 weeks prior to screening.

Exclusion

Current or planned implantation of a cardiac implantable electronic device (eg, pacemaker, implantable cardiac defibrillator).
Acute myocardial infarction, acute coronary syndrome or coronary revascularization, or experienced stroke or transient ischemic attack within 90 days prior to screening.
Hemodynamic instability.
Likely to undergo heart transplantation within 12 months from screening.
Confirmed diagnosis of AL amyloidosis at screening.
At screening: NYHA Class III/IV; National Amyloidosis Center (NAC) Stage 3.
Prior or current treatment with acoramidis.
  • To assess the effect of acoramidis on cardiac function improvement by CMR in participants with ATTR-CM.Month 36

    Change from baseline in left ventricular ejection fraction (LVEF) or left ventricular stroke volume index (LVSVi) at Month 36.