[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mapi Pharma Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28],"Diabete Type 2",[30,31,32,33,34],"Diabetes","Semaglutide Depot","Long-acting semaglutide","SG Depot","semaglutide LAI","NOT_YET_RECRUITING","2026-06-28",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":21},"2026-07",{"date":43,"type":21},"2028-05",{"name":45,"class":46},"Mapi Pharma Ltd.","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100607227","phase-1-pharmacokinetics-safety-tolerability-and-efficacy-of-a-subcutaneous-long-acting-injection-of-cariprazine-cariprazine-depot-in-subjects-eligible-for-treatment-with-oral-cariprazine-100607227","NCT07185815","Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine","A Prospective, Dose Escalating, Open Label, Multi-center, Phase I\u002FIIa Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine.","Key Inclusion Criteria:\n\n* Subjects who meet DSM-5-TR diagnostic criteria for schizophrenia, bipolar I disorder or major depressive disorder (this inclusion criterion relates to cohorts 1 and 2 only).\n* Clinically stable subjects (with no evidence of deterioration and on a stable dose of oral antipsychotic or antidepressant medication(s) other than Cariprazine for at least 4 weeks, prior to screening), receiving antipsychotic\u002Fs or antidepressant\u002Fs other than oral Cariprazine and eligible for treatment with Cariprazine 3 mg\u002Fday, with CGI-S score of 1-4.\n* Men and women aged 18-64 years (inclusive).\n* Body mass index (BMI) 18.5-35.\n* Able to sign an informed consent form.\n* Adult subjects with a current diagnosis of schizophrenia, who meet DSM-5-TR diagnostic criteria for schizophrenia, naïve to or treated with antipsychotics (this inclusion criterion relates to cohort 3 only).\n\nKey Exclusion Criteria:\n\n* Subjects with schizophrenia with PANSS item scores of \\> 4 on any of the following: P4 Excitement\u002FHyperactivity; P6 Suspiciousness\u002Fpersecution; P7 Hostility; G8 Uncooperativeness; G14 Poor impulse control.\n* Subjects with schizoaffective disorder, delirium, dementia, amnestic, or other cognitive disorders or severe personality disorders.\n* Use of an investigational drug, and\u002For participation in clinical studies with an investigational product within 3 months prior to screening.\n* History or current cardiovascular or cerebrovascular disease.\n* History of seizures or conditions that lower the seizure threshold.\n* Use of concomitant administration of strong or moderate CYP3A4 inhibitors.\n* Use of concomitant medication of strong or moderate CYP3A4 inducers is contraindicated.\n* Subjects with Suicidal Thoughts and Behaviors or has a history of suicidal ideation in the past year, or made a suicide attempt in the past 5 years.\n* Subjects with a history of orthostatic hypotension and\u002For syncope.\n* Subjects clinically stable on any dose of oral Cariprazine or add-on treatment (cohorts 1-2 only).\n* Subjects with CGI-S score of 5-7.\n* Subjects previously treated with partial D2 agonists, aripiprazole and brexipiprazole, and suffered from clinically relevant akathisia.\n* For cohort 3 only: Subjects treated with oral Clozapine.",{"count":20,"type":21},[24,25],"The purpose of this study is to assess the PK, Safety, Tolerability (all cohorts) and Efficacy (cohort 3), of once-a-month long-acting SC injection of dose escalating Cariprazine Depot in subjects eligible for treatment with oral Cariprazine.",[59,60,61],"Schizophrenia","Bipolar I Disorder","Major Depressive Disorder",[63,64,65,66,67,68],"Long acting injection","LAI","Subcutaneous","SC","Cariprazine","Cariprazine Depot","RECRUITING","2026-04-27",{"date":72,"type":39},"2026-05-01",{"date":74,"type":39},"2025-08-01",{"date":76,"type":21},"2027-06-03",{"name":45,"class":46},6,""]