[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636285":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":11,"centralContacts":44,"locations":50,"responsibleParty":63,"collaborators":11,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":11,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":11,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":91,"whyStopped":11,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Mapi Pharma Ltd.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1 - SG Depot 2 mg","EXPERIMENTAL",null,[13],"Drug: SG Depot 2 mg",{"label":15,"type":10,"description":11,"interventionNames":16},"Cohort 2 - SG Depot 4 mg",[17],"Drug: SG Depot 4 mg",{"label":19,"type":10,"description":11,"interventionNames":20},"Cohort 3 - SG Depot 6 mg",[21],"Drug: SG Depot 6 mg",{"label":23,"type":10,"description":11,"interventionNames":24},"Cohort 4 - SG Depot 8 mg",[25],"Drug: SG Depot 8 mg",[27,32,36,40],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"DRUG","SG Depot 2 mg","2 mg administered subcutaneously (s.c., under the skin) once every 4 weeks",[9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"SG Depot 4 mg","4 mg administered subcutaneously (s.c., under the skin) once every 4 weeks",[15],{"type":28,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"SG Depot 6 mg","6 mg administered subcutaneously (s.c., under the skin) once every 4 weeks",[19],{"type":28,"name":41,"description":42,"armGroupLabels":43,"otherNames":11},"SG Depot 8 mg","8 mg administered subcutaneously (s.c., under the skin) once every 4 weeks",[23],[45],{"name":46,"role":47,"phone":48,"phoneExt":11,"email":49},"Roy Eldor, Professor","CONTACT","972-36974243","roye@tlvmc.gov.il",[51],{"facility":52,"status":11,"city":53,"state":11,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":11},"Mapi pharma Investigational Site ISR001","Tel Aviv","6423906","Israel","IL",{"type":58,"coordinates":59},"Point",[60,61],34.78057,32.08088,{"lat":61,"lon":60},{"type":64,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100636285","phase-1-safety-tolerability-and-efficacy-of-semaglutide-depot-in-subjects-with-type-2-diabetes-mellitus-100636285",false,"NCT07563699","Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus","A Prospective, Multicenter, Open Label, Dose Escalation Phase I\u002FIIa Study to Assess the Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus","Inclusion Criteria:\n\n1. Adults aged 18-64 years with T2DM, BMI 25-35 kg\u002Fm2\n2. On stable Semaglutide 1 mg weekly and for at least 3 months\n3. HbA1c \\\u003C8%, eGFR≥60 ml\u002Fminute\n4. For women: either non-childbearing potential or agreement to use acceptable contraception\n\nExclusion Criteria:\n\n1. Participation in another investigational drug clinical study within 3 months\n2. History of cardiovascular or cerebrovascular disease\n3. Neuropathy or retinopathy or macular edema necessitating medical treatment\n4. Type 1 diabetes\n5. Unstable weight (\\> 5% change in the last 3 months)\n6. Current use of insulin and \u002For sulfonylureas and\u002For glinides\n7. Known contraindications to Semaglutide (per FDA-approved Semaglutide label)\n8. Recent immunosuppressive therapy (within 90 days) or chemotherapy for malignancy within 5 years\n9. Moderate or severe hepatic impairment, (ALT or AST\\> 2 x upper limit of normal (ULN)\n10. Severe hypertriglyceridemia (triglycerides \\>500 mg\u002Fdl)\n11. Pregnant or breast feeding\n12. Any condition that may increase risk or interfere with study participation (per Investigator judgement)","ALL","18 Years","64 Years",{"count":76,"type":77},24,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE1","PHASE2","Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is an approved and well-established therapy for type 2 diabetes mellitus (T2DM), providing both robust glycemic control and weight reduction. Semaglutide Depot, is a long-acting formulation of semaglutide, designed for once every four weeks administration, intended to reduce treatment burden, and improve adherence supporting sustained glycemic control over time.\n\nThis Phase I\u002FIla dose escalation study design to evaluate the safety, tolerability, pharmacokinetics and efficacy of Semaglutide Depot in adults with T2DM.",[84],"Diabete Type 2",[86,87,88,89,90],"Diabetes","Semaglutide Depot","Long-acting semaglutide","SG Depot","semaglutide LAI","NOT_YET_RECRUITING","2026-06-28",{"date":94,"type":95},"2026-06-30","ACTUAL",{"date":97,"type":77},"2026-07",{"date":99,"type":77},"2028-05",{"name":5,"class":6},1]