Cardiac Magnetic Resonance and Echocardiography Study With Acoramidis

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEidos Therapeutics, a BridgeBio company

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Acoramidis (AG10) oral tablet

Treatment groups

150 Participants
are divided into 1 treatment group