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Clinical Trials in the USA / NCT07695701
Recruiting Phase 4

Cardiac Magnetic Resonance and Echocardiography Study With Acoramidis

NCT07695701 · tracked via the Priya Life Science USA tracker
Sponsor
Eidos Therapeutics, a BridgeBio company
Phase
Phase 4
Started
2026-07
Last updated
2026-07-29

Condition(s) studied

Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)AmyloidosisAmyloid CardiomyopathyTransthyretin Amyloidosis

Investigational drug(s) / intervention(s)

Acoramidis (AG10) oral tablet

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Key Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Washington University in St. Louis St Louis Missouri Recruiting

More Eidos Therapeutics, a BridgeBio company trials in the USA

Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants Active, not recruiting
Acoramidis Transthyretin Amyloidosis Prevention Trial in the Young (ACT-EARLY) Study in Asymptomatic Carriers of a Pathogenic TTR Variant Recruiting

Other trials for the same condition

A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis Active, not recruiting
Non-interventional Study of Patients With Transthyretin (ATTR) Amyloidosis Recruiting
A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloidosis. Recruiting
A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis Recruiting
Acoramidis Transthyretin Amyloidosis Prevention Trial in the Young (ACT-EARLY) Study in Asymptomatic Carriers of a Pathogenic TTR Variant Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07695701 on ClinicalTrials.gov ↗ ← All trials in the USA