[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572322":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":44,"centralContacts":48,"locations":59,"responsibleParty":77,"collaborators":53,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":53,"eligibilityCriteria":84,"healthyVolunteers":81,"sex":85,"minAge":86,"maxAge":53,"enrollmentInfo":87,"targetDuration":53,"studyType":90,"phases":91,"briefSummary":94,"conditions":95,"keywords":53,"overallStatus":61,"whyStopped":53,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"UConn Health","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Levothyroxine alone","ACTIVE_COMPARATOR","Patients in this arm will be administered Levothyroxine\u002FPlacebo",[13],"Drug: Levothyroxine",{"label":15,"type":16,"description":17,"interventionNames":18},"Combination therapy liothyronine once daily","EXPERIMENTAL","Patients in the arm will be administered Levothyroxine\u002FLiothyronine with Liothyronine administered once daily plus placebo",[13,19],"Drug: Levothyroxine\u002FLiothyronine once daily",{"label":21,"type":16,"description":22,"interventionNames":23},"Combination therapy liothyronine twice daily","Patients in this arm will be administered Levothyroxine\u002FLiothyronine with Liothyronine administered twice daily.",[13,24],"Drug: Levothyroxine\u002FLiothyronine twice daily",[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Levothyroxine","Patients will receive Levothyroxine\u002FPlacebo\n\nLevothyroxine\u002FLiothyronine with Liothyronine administered twice daily.",[15,21,9],[32],"LT4",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Levothyroxine\u002FLiothyronine once daily","Patients will receive Levothyroxine\u002FLiothyronine with Liothyronine administered once daily;",[15],[38],"LT4\u002FLT3",{"type":27,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Levothyroxine\u002FLiothyronine twice daily","Patients will receive Levothyroxine\u002FLiothyronine with Liothyronine administered twice daily;",[21],[38],[45],{"name":46,"affiliation":5,"role":47},"Francesco Celi","PRINCIPAL_INVESTIGATOR",[49,55],{"name":50,"role":51,"phone":52,"phoneExt":53,"email":54},"Francesco S Celi, MD, MHSc.","CONTACT","(860) 679-2715",null,"celi@uchc.edu",{"name":56,"role":51,"phone":57,"phoneExt":53,"email":58},"Nicole Glidden","(860) 679-4647","DOMClinicalResearch@uchc.edu",[60],{"facility":5,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"RECRUITING","Farmington","Connecticut","06030","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-72.83204,41.71982,{"lat":71,"lon":70},[74,75],{"name":56,"role":51,"phone":57,"phoneExt":53,"email":58},{"name":76,"role":51,"phone":57,"phoneExt":53,"email":58},"Jenny Derouen",{"type":47,"investigatorFullName":46,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Professor","100572322","phase-2-novel-approaches-to-the-treatment-of-hypothyroidism-100572322",false,"NCT06731764","Novel Approaches to the Treatment of Hypothyroidism","Inclusion Criteria:\n\nHistory of hypothyroidism Treatment with levothyroxine Levothyroxine dose \\>1.2 mcg\u002Fkg\n\nExclusion Criteria:\n\nBody weight \\\u003C50 or \\>100 Kg.\n\nIndication for TSH suppression (high risk follicular-derived thyroid cancer).\n\nSecondary (pituitary) hypothyroidism (ICD-10 E23.0); Pregnancy; breastfeeding; uncontrolled diabetes (HbA1c \\>8.5% at screening); use of oral Semaglutide (Rybelsus); Uncontrolled Hypertension (BP \\> 140\u002F90 at screening); current use of T3-containing therapies (Liothyronine, desiccated thyroid extracts).\n\nPatients receiving lipid-lowering therapies must maintain the same dose throughout the participation in the study. Changes in lipid lowering therapy\u002Fdose will result in termination from the study.\n\nPatients receiving anti-acid (H2 blockers, proton pump inhibitors) therapies must maintain the same dose throughout the participation in the study. Changes in anti-acid therapy\u002Fdose will result in termination from the study. Use of other medications known to interfere with the absorption of thyroid hormone, or affecting the thyroid hormone axis (Burch 2019) will be considered exclusion criteria.\n\nBariatric surgery, initiation of GLP-1 agonist therapy (irrespective of the indication), enrollment in structured weight loss programs will result in dismissal from the study.\n\nCurrent pregnancy, pregnancy planned within the next 6 months, and lack of contraception in women of reproductive age will be exclusionary. We will verify that the participant is not pregnant through a urine pregnancy test at the time of the first study visit and at each of the follow-up visits. Any participants who become pregnant will terminate the study.","ALL","18 Years",{"count":88,"type":89},90,"ESTIMATED","INTERVENTIONAL",[92,93],"PHASE2","PHASE3","Hypothyroidism is a common condition, more frequent in females, associated with excess of cardiovascular risk and poor quality of life not completely abrogated by treatment with levothyroxine.\n\nThere is an unmet need to define a safe, effective, and feasible regimen to be applied in large trials aimed at assessing levothyroxine\u002Fliothyronine combination therapy in patients living with hypothyroidism.\n\nTo address this knowledge gap we propose a randomized, three-arm, double-blind, controlled, escalating dose parallel pilot study whose results will lay the foundation of large multicenter trial(s) able to demonstrate the effectiveness (or lack thereof) of levothyroxine\u002Fliothyronine combination therapy.",[96],"Hypothyroidism","2026-03-17",{"date":99,"type":100},"2026-03-19","ACTUAL",{"date":102,"type":100},"2024-12-10",{"date":104,"type":89},"2028-06-30",{"name":5,"class":6},1]