[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634575":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":37,"collaborators":7,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":7,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":47,"minAge":7,"maxAge":7,"enrollmentInfo":48,"targetDuration":51,"studyType":52,"phases":7,"briefSummary":53,"conditions":54,"keywords":7,"overallStatus":21,"whyStopped":7,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},{"fullName":5,"class":6},"Madrigal Pharmaceuticals, Inc.","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DRUG","Rezdiffra","Exposure to at least one dose of Resmetirom.",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Madrigal Pharmaceuticals","CONTACT","800-905-0324","MHGSafety@iconplc.com",[20],{"facility":15,"status":21,"city":22,"state":23,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"RECRUITING","West Conshohocken","Pennsylvania","19428","United States","US",{"type":28,"coordinates":29},"Point",[30,31],-75.3163,40.06983,{"lat":31,"lon":30},[34],{"name":35,"role":16,"phone":36,"phoneExt":7,"email":18},"Event Reporting Desk","1-800-905-0324",{"type":38,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100634575","rezdiffra-pregnancy-and-lactation-registry-100634575",false,"NCT07541469","Rezdiffra Pregnancy and Lactation Registry","A Phase 4, Decentralized Observational Registry to Evaluate the Safety in Women With NASH and Their Infants Exposed to REZDIFFRA™ (Resmetirom) During Pregnancy and\u002For Lactation","Inclusion Criteria:\n\n1. Female patients with NASH who have been exposed to at least 1 dose of resmetirom at any time during pregnancy (defined as having received resmetirom within 3 days prior to the date of conception and\u002For during pregnancy) and\u002For during lactation, and their infants (up to 12 months of age).\n2. Patient or parent\u002Flegally authorized representative must be able to understand and provide consent through an Institutional Review Board\u002FIndependent Ethics Committee (IRB\u002FIEC)-approved informed consent or assent form.\n\nExclusion Criteria:\n\nNONE",true,"FEMALE",{"count":49,"type":50},10,"ESTIMATED","21 Months","OBSERVATIONAL","To evaluate pregnancy and clinical outcomes in women with NASH and their infants after exposure to Rezdiffra at any time during pregnancy and\u002For lactation.",[55],"MASH - Metabolic Dysfunction-Associated Steatohepatitis","2026-04-14",{"date":58,"type":59},"2026-04-21","ACTUAL",{"date":61,"type":59},"2026-03-04",{"date":63,"type":50},"2030-04-08",{"name":5,"class":6},1]