[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiomyopathy-secondary\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiomyopathy-secondary":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":5},"100648332","phase-2-study-of-lx2006-gene-therapy-in-friedreich-ataxia-cardiomyopathy-100648332",false,"NCT07721025","Study of LX2006 Gene Therapy in Friedreich Ataxia Cardiomyopathy","A Phase 2, Multicenter, Open-label, Randomized, Controlled Study of LX2006 Gene Therapy in Participants With Friedreich Ataxia Cardiomyopathy (SUNRISE-FA 2)","SUNRISE-FA 2","Inclusion Criteria:\n\n* Male or female, age at least 6 years at the time of signing the informed consent (and assent, if applicable).\n* Diagnosis of FA, based on clinical phenotype and genotype (GAA expansion on the frataxin gene)\n* Onset of FA on or before 25 years of age\n* Confirmed left ventricular hypertrophy and abnormal left ventricular mass index\n* Left ventricular ejection fraction at least 30%\n* Anti-AAVrh.10 total antibody titer less than the protocol-specified maximum level\n\nExclusion Criteria:\n\n* Presence of other forms of cardiomyopathy that contribute to heart failure\n* Current use of inotrope infusion or presence of a ventricular assist device\n* Contraindication to cardiac MRI\n* Prior organ transplant\n* Previous gene transfer or cell therapy\n* Poorly controlled diabetes (hemoglobin A1c ≥8%)\n* Active hematologic or solid organ cancer\n\nOther inclusion\u002Fexclusion criteria to be applied as per protocol.","ALL","6 Years",{"count":20,"type":21},26,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of Study LX2006-03, a multicenter, Phase 2, open-label, randomized, controlled study, is to evaluate the efficacy and safety of LX2006 gene therapy in participants with Friedreich ataxia (FA) cardiomyopathy (CM).",[27,28],"Friedreich Ataxia","Cardiomyopathy, Secondary",[30,31,27,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,15,47,48],"Friedreich Ataxia Cardiomyopathy","FA-CM","Friedreich's Ataxia","FA","FRDA","Cardiomyopathy","Genetic Cardiomyopathy","Mitochondrial Cardiomyopathy","Cardiac Disease","Left Ventricular Hypertrophy","Hypertrophic Cardiomyopathy (Non-Obstructive)","HCM","Gene Therapy","FXN Gene","FXN","Frataxin Gene","LX2006","SUNRISE-FA","CLARITY","RECRUITING","2026-07-20",{"date":52,"type":53},"2026-07-22","ACTUAL",{"date":55,"type":53},"2026-06-25",{"date":57,"type":21},"2032-06",{"name":59,"class":60},"Lexeo Therapeutics","INDUSTRY"]