[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07695701":3,"trial-entities:NCT07695701":102,"trial-summary:NCT07695701":106},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":42,"secondary_outcomes":47,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":14,"eligibility_criteria":65,"std_ages":80,"locations":83,"central_contacts":93,"overall_officials":99,"references":100,"see_also_links":101},"NCT07695701","AG10-404","Cardiac Magnetic Resonance and Echocardiography Study With Acoramidis","An Open-Label Study to Investigate the Long-Term Effects of Acoramidis on Cardiac Function, Structure and Cardiac Amyloid Burden in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)","RECRUITING","2030-11","2026-07","2026-07-29","Eidos Therapeutics, a BridgeBio company","INDUSTRY",false,"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.\n\nUp 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.",[18,19,20,21],"Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)","Amyloidosis","Amyloid Cardiomyopathy","Transthyretin Amyloidosis",[23,24,25,26,27],"amyloidosis","cardiomyopathy","ATTR-CM","Amyloid","TTR","INTERVENTIONAL","TREATMENT",[31],"PHASE4",{"count":33,"type":34},150,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40},"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.",[41],"Acoramidis (AG10)",[43],{"measure":44,"description":45,"timeFrame":46},"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.","Month 36",[48,51,53,56,59],{"measure":49,"description":50,"timeFrame":46},"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",{"measure":52,"description":50,"timeFrame":46},"To assess the effect of acoramidis on cardiac function stabilization by CMR in participants with ATTR-CM.",{"measure":54,"description":55,"timeFrame":46},"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",{"measure":57,"description":58,"timeFrame":46},"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",{"measure":60,"description":61,"timeFrame":46},"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","ALL","18 Years","80 Years",{"inclusion":66,"exclusion":71,"raw_text":79},[67,68,69,70],"Participants aged 18 to 80","Confirmed diagnosis of ATTR-CM requiring targeted therapy","At screening: New York Heart Association (NYHA) Class I\u002FII; estimated glomerular filtration rate (eGFR) ≥40 mL\u002Fmin\u002F1.73m2; 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.",[72,73,74,75,76,77,78],"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\u002FIV; National Amyloidosis Center (NAC) Stage 3.","Prior or current treatment with acoramidis.","Key Inclusion Criteria:\n\n* Participants aged 18 to 80\n* Confirmed diagnosis of ATTR-CM requiring targeted therapy\n* At screening: New York Heart Association (NYHA) Class I\u002FII; estimated glomerular filtration rate (eGFR) ≥40 mL\u002Fmin\u002F1.73m2; left ventricular ejection fraction (LVEF) \\>35%; left ventricular (LV) wall thickness ≥12 mm.\n* Heart failure condition has been clinically stable for at least 6 weeks prior to screening.\n\nKey Exclusion Criteria:\n\n* Current or planned implantation of a cardiac implantable electronic device (eg, pacemaker, implantable cardiac defibrillator).\n* Acute myocardial infarction, acute coronary syndrome or coronary revascularization, or experienced stroke or transient ischemic attack within 90 days prior to screening.\n* Hemodynamic instability.\n* Likely to undergo heart transplantation within 12 months from screening.\n* Confirmed diagnosis of AL amyloidosis at screening.\n* At screening: NYHA Class III\u002FIV; National Amyloidosis Center (NAC) Stage 3.\n* Prior or current treatment with acoramidis.",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":85,"status":8,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"Washington University in St. Louis","St Louis","Missouri","63110","United States",{"lat":91,"lon":92},38.62727,-90.19789,[94],{"name":95,"role":96,"phone":97,"email":98},"Medical Information","CONTACT","1-844-550-2246","medinfo@bridgebio.com",[],[],[],{"nct_id":4,"conditions":103,"biomarkers":105},[104],"Transthyretin related familial amyloid cardiomyopathy",[],{"nct_id":4,"found":107,"summary":108,"prompt_version":118},true,{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"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.","completed","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.","You will be followed for 30 days (+7 days) after your last dose of acoramidis.",109,"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.","Not stated in the trial record.",[],"v2"]