[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"vTv Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100541766","phase-3-cadisegliatin-as-adjunctive-therapy-to-insulin-in-participants-with-type-1-diabetes-100541766",false,"NCT06334133","Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes","Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes: A 26-Week Double-Blind, Randomized, Placebo-Controlled Phase 3 Study","CATT1","Inclusion Criteria:\n\n* Individuals ≥18 years\n* Diagnosed T1DM with a minimum of 3 years since diagnosis\n* Has had at least 1 hypoglycemic event of Level 2 (glucose level \\\u003C54 mg\u002FdL or \\\u003C3 mmol\u002FL, \\[CGM or SMBG confirmed\\]) or Level 3 (defined as a severe hypoglycemia with altered mental state and\u002For physical status requiring assistance) in the last 2 months prior to Screening\n* HbA1c value of \\\u003C9.5% at Screening\n* Is currently on CSII (closed-loop systems are prohibited) or is on MDI for at least 6 months prior to the Screening Visit and is willing to stay on same type of insulin treatment and the current mode of insulin administration (CSII or MDI injection treatments) for the duration of the study\n* Must have been on a CGM device for at least 3 months prior to Screening\n\nExclusion Criteria:\n\n* Has T2DM, monogenic diabetes, maturity-onset diabetes of the young, other unusual or rare forms of diabetes mellitus, or diabetes resulting from a secondary disease\n* Has been hospitalized for DKA within 3 months prior to Screening\n* Has uncontrolled hypothyroidism or hyperthyroidism\n* History of eating disorder within the last 2 years such as anorexia, bulimia, diabulimia or neglecting to give insulin to manipulate weight\n* Has an active or untreated malignancy, or has been in remission from malignancy for ≤5 years except well-treated basal cell or squamous cell skin cancer or cervical cancer in situ\n* Has used any of the following medications within the specified time periods - any non-insulin anti-diabetic therapies, e.g., sodium glucose cotransporter-2 (SGLT-2) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, metformin, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, or pramlintide, alpha-glucosidase inhibitors, or glucose-dependent insulinotropic polypeptide agonists) or weight loss medications within 30 days prior to the Screening\n* Has used a hybrid closed-loop system (e.g., Medtronic 670G, Omnipod 5, or Tandem X2 with control IQ) or Do-It-Yourself looping within the last 30 days prior to the Screening Visit, and agrees to not start hybrid closed-loop systems or Do-It-Yourself looping during the study.\n* Has an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2 utilizing the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening\n* Has uncontrolled hypertension prior to Screening","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus.",[27],"Diabetes Mellitus, Type 1","RECRUITING","2026-05-29",{"date":31,"type":32},"2026-06-02","ACTUAL",{"date":34,"type":32},"2024-06-14",{"date":36,"type":21},"2026-10",{"name":38,"class":39},"vTv Therapeutics","INDUSTRY",61,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100637915","phase-2-cadisegliatin-as-adjunctive-therapy-to-insulin-in-participants-with-type-1-diabetes-who-are-using-hybrid-closed-loop-hcl-systems-100637915","NCT07616206","Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems","Hybrid CATT1: Hybrid Closed Loop Insulin Pumps With Cadisegliatin as Adjunctive Treatment in Patients With Type 1 Diabetes A Phase 2a Double Blind Randomized Cross-Over Study","Hybrid CATT1","Key Inclusion Criteria:\n\n* Participants \\>= 18 years of age\n* Fasting plasma C-peptide levels \\\u003C0.6 ng\u002Fml\n* Average TIR \\\u003C 70% at the end of the screening period\n* Currently on a hybrid closed loop device for at least 3 months and willing to stay on the same model of pump device for study duration\n* Willing to wear a study provided CGM for study duration\n* Capable of participating in a 30-minute lasting exercise test\n\nKey Exclusion Criteria:\n\n* Have Type 2 Diabetes Mellitus (DM), monogenic diabetes, maturity-onset diabetes, other unusual or rare forms of DM, or diabetes resulting from a secondary disease.\n* Have been hospitalized for DKA within 3 months\n* Have uncontrolled hypothyroidism or hyperthyroidism\n* Have QTcF interval \\> 450 msec for males or \\> 470 msec for females\n* Have a personal or family history of long QT syndrome, Torsades de pointes, or other complex ventricular arrhythmias\n* Have persistent, uncontrolled hypertension\n* Have clinically significant cardiovascular or cerebrovascular disease\n* Have proliferative retinopathy or maculopathy requiring acute treatment\n* Have a serious concomitant systemic disorder incliuding but not limited to HIV or active Hep B or Hep C\n* Diagnosed and\u002For treated for malignancy within 3 years\n* Have used any of the following medications within the specified time periods: any non-insulin anti-diabetic therapies (e.g.SGLT-2 inhibitors, GLP-1 receptor agonists, metformin, sulfonylureas, DPP-4 inhibitors, pramlintide, a-glucosidase inhibitors, or glucose dependent insulinotropic polypeptide agonists) within 30 days, antipsychotic medications (e.g. olanzapine, risperidone, clozapine, quetiapine, and haloperidol) within 30 days, systemic corticosteroids for ≥7 days for a temporary medical condition within 30 days,",{"count":50,"type":21},40,[52],"PHASE2","TTP399-206 is a Phase 2a multicenter double blind cross over randomized study of cadisegliatin in participants with T1D using hybrid closed loop systems to manager their diabetes. Patients using a hybrid closed loop insulin pump to manage their diabetes will be randomized to either receive blinded cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment or placebo QD along with their insulin treatment. The trial begins with a screening period of up to 2 weeks, followed by a device training and insulin adjustment period of 1-2 weeks leading into the first double-blind treatment period of 6 weeks. There will then be a washout period of 1-2 weeks followed by the second double-blind treatment period of 6 weeks where the patient will cross-over to the treatment arm that they did not receive in the first treatment period.",[55],"Type 1 Diabetes (T1D)",[57],"Hybrid Closed Loop","NOT_YET_RECRUITING","2026-05-22",{"date":61,"type":32},"2026-06-01",{"date":63,"type":21},"2026-07",{"date":65,"type":21},"2027-05",{"name":38,"class":39},1,""]