Cardiac Magnetic Resonance and Echocardiography Study With Acoramidis

Recruiting · NCT07695701 · Interventional (participants receive a specific treatment) · Lead sponsor: Eidos Therapeutics, a BridgeBio company

Interventions studied

Acoramidis (AG10) oral tablet

The study aims to evaluate the effect of acoramidis on cardiac functional and structural improvement in participants with ATTR-CM.

Age range

18 Years to 80 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 4

Study type

Interventional (participants receive a specific treatment)

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.
Key

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.

1 location listed across 1 US state.