[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471832":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":45,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":31,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":31,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":47,"whyStopped":31,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Virginia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Semaglutide","EXPERIMENTAL","Semaglutide administered subcutaneously (under the skin) once weekly. There will be a 20 week lead in period of dose escalation before reaching the target dose of 2.4mg weekly. Semaglutide will then be administered at the maximum tolerated dose for 52 weeks.",[13],"Drug: Semaglutide Pen Injector",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo administered subcutaneously (under the skin) once weekly.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Semaglutide Pen Injector","Starting dose of 0.24 mg injected weekly and increased every 4 weeks to a potential maximum dose of 2.4 mg weekly at 20 weeks followed by 52 weeks of weekly injections at the maximum tolerable dose",[9],[27],"Wegovy",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Placebo solution injected weekly for 72 weeks",[15],null,[33],{"name":34,"affiliation":35,"role":36},"Mohammad S Siddiqui, MD","Virginia Commonwealth University","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":31,"email":42},"Sherry Boyett, RN","CONTACT","804-828-5434","sherry.boyett@vcuhealth.org",{"name":34,"role":40,"phone":31,"phoneExt":31,"email":44},"mohammad.siddiqui@vcuhealth.org",[46],{"facility":35,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":31},"RECRUITING","Richmond","Virginia","23298","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-77.46026,37.55376,{"lat":57,"lon":56},{"type":36,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Mohammad Siddiqui","Professor of Medicine",[63],{"name":64,"class":65},"Novo Nordisk A\u002FS","INDUSTRY","100471832","phase-2-randomized-double-blinded-placebo-controlled-wsemaglutide-to-prevent-weight-gain-after-liver-transplant-100471832",false,"NCT05424003","Randomized Double Blinded Placebo-Controlled w\u002FSemaglutide to Prevent Weight Gain After Liver Transplant","A Randomized Double Blinded Placebo-Controlled Trial of Semaglutide to Prevent Weight Gain Following Liver Transplantation","Inclusion Criteria:\n\n* Male or female age 18-75 years who received LT for any indication (i.e. NASH, hepatitis C, alcohol-induced cirrhosis, autoimmune hepatitis, etc.)\n* Liver transplant surgery within 8-24 weeks prior to randomization\n* Fasting glucose \\> 125 mg\u002FdL or presence of diabetes (HbA1c≥6.5% or use of diabetes medications) or pre-diabetes (HbA1c \\>5.7%)\n* Ability to provide informed consent\n* Discharged from the hospital following LT surgery\n* Tolerating diet\n* Normal graft function\\* (determined by treating hepatologist\u002Fsurgeon based on clinical status and hepatic panel)\n* Stable immunosuppression according the VCU (Virginia Commonwealth University) post-LT protocols \\*\\* (i.e. calcineurin inhibitors + mycophenolate)\n* Eligible female patients will be (1) non-pregnant, evidenced by a negative urine pregnancy test, (2) non-lactating, (3)surgically sterile or post-menopausal, or they will agree to continue to use an accepted method of birth control during the study\n\nExclusion Criteria:\n\n* BMI≤ 27kg\u002Fm2\n* GFR (Glomerular Filtration Rate) ≤ 25 ml\u002Fmin\u002F1.73m2\n* Type 1 autoimmune diabetes (by anti-GAD (glutamic acid decarboxylase) or history of ketoacidosis)\n* History of gastroparesis\n* Familial or personal history of medullary thyroid cancer or MEN (Multiple Endocrine Neoplasia) 2\n* History of pancreatitis\n* History of active malignancy post- LT with the exception of non-melanoma skin cancers\n* History of uncontrolled or unstable diabetic retinopathy or maculopathy\n* Acute cellular rejection\n* Hepatic artery thrombosis\n* Medical non-compliance\n* Active treatment with GLP (glucagon-like peptide)-1RA (receptor agonist) or SGLT (sodium-glucose cotransporter)-2 inhibitors at time of screening\n* History of hypersensitivity to semaglutide or its excipients\n* Women who are nursing, pregnant, or planning to become pregnant during the study, or are not using adequate contraceptive measures","ALL","18 Years","75 Years",{"count":77,"type":78},50,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","In this study, semaglutide will be compared to placebo (a look-alike inactive substance, a \"sugar pill\") to determine if its use will prevent weight gain after liver transplantation (LT). In addition, researchers will be testing to determine if semaglutide prevents the development of Non-Alcoholic Fatty Liver Disease (NAFLD) after transplant through Magnetic Resonance Imaging (MRI) and laboratory results.",[84],"NAFLD",[86],"Liver Transplant","2026-06-02",{"date":89,"type":90},"2026-06-04","ACTUAL",{"date":92,"type":90},"2024-02-22",{"date":94,"type":78},"2026-08-01",{"name":5,"class":6},1]