[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100317598":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":28,"locations":33,"responsibleParty":67,"collaborators":28,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":28,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":28,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":28,"overallStatus":88,"whyStopped":28,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Daily dose escalation (click-by-click): Starting at dose 1 in the morning with daily increments to dose 2. During the escalation phase, the dose will only be increased if the patient is feeling fine.",[13],"Drug: SAR425899",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","Weekly dose escalation in 6 escalation steps (7 dose levels): Starting at dose 1 injected in the morning with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3","Weekly dose escalation in 4 escalation steps (5 dose levels): Starting at dose 3 with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","SAR425899","Pharmaceutical form: Solution\n\nRoute of administration: Subcutaneous",[9,15,19],null,[30],{"name":31,"affiliation":5,"role":32},"Clinical Sciences & Operations","STUDY_DIRECTOR",[34,47,57],{"facility":35,"status":28,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":28},"Investigational Site Number 8400002","Saint Paul","Minnesota","55144","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-93.09327,44.94441,{"lat":45,"lon":44},{"facility":48,"status":28,"city":49,"state":50,"zip":51,"country":39,"countryCode":40,"cosmosGeoPoint":52,"geoPoint":56,"contacts":28},"Investigational Site Number 8400003","Knoxville","Tennessee","37920",{"type":42,"coordinates":53},[54,55],-83.92074,35.96064,{"lat":55,"lon":54},{"facility":58,"status":28,"city":59,"state":60,"zip":61,"country":39,"countryCode":40,"cosmosGeoPoint":62,"geoPoint":66,"contacts":28},"Investigational Site Number 8400001","Austin","Texas","78744",{"type":42,"coordinates":63},[64,65],-97.74306,30.26715,{"lat":65,"lon":64},{"type":68,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100317598","phase-1-a-study-on-safety-and-tolerability-of-sar425899-in-overweight-to-obese-subjects-and-type-2-diabetes-mellitus-patients-not-requiring-anti-diabetic-pharmacotherapy-with-an-optional-6-month-safety-extension-period-100317598",false,"NCT03414736","A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy With an Optional 6-month Safety Extension Period","A Randomized, Comparative, Open Label Study to Assess the Safety and Tolerability of 3-arm, Parallel, Repeated Subcutaneous Dose Regimens of SAR425899 in Overweight to Obese Subjects and T2DM Patients Not Requiring Anti-diabetic Pharmacotherapy, With an Optional 6-month Safety Extension Period","Inclusion criteria:\n\n* Male or female overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy.\n* Patients who are motivated to lose weight.\n\nExclusion criteria:\n\n* Type 1 diabetes mellitus.\n* Body mass index \\\u003C27 kg\u002Fm2.\n* Screening hemoglobin A1c (HbA1c; glycosylated hemoglobin) \\>7.0%.\n* Previous treatment with glucose-lowering agent(s) (eg, insulin, thiazolidinediones, metformin, DPP-IV inhibitors (dipeptidylpeptidase 4), SGLT-2 (sodium dependent glucose transporter-2) inhibitors, etc) within the last 6 months.\n* Previous treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within the last 6 months.\n* Uncontrolled hypertension.\n* Laboratory findings at the time of screening: amylase and\u002For lipase \\>2 times the upper limit of the normal laboratory range (ULN), alanine aminotransferase \\>1.5 ULN, total bilirubin \\>1.5 ULN, serum creatinine levels ≥1.5 mg\u002FdL \\[males\\]. ≥1.4 mg\u002FdL \\[females\\], screening calcitonin ≥20 pmol\u002Fm, fasting serum triglycerides \\>400 mg\u002FdL.\n* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC.\n* History of weight loss surgery.\n* History of pancreatitis or pancreatectomy.\n* Pregnant or lactating women.\n* Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and\u002For who are unwilling or unable to be tested for pregnancy.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","ALL","18 Years","75 Years",{"count":80,"type":81},60,"ACTUAL","INTERVENTIONAL",[84],"PHASE1","Primary Objectives:\n\n* Main study: To assess in overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability of 3 different dose escalation regimens of SAR425899 in terms of the relative and absolute frequency and severity of gastrointestinal (GI) adverse events (AEs).\n* Six-month safety extension period: To assess the safety and tolerability of SAR425899 after 6 months treatment at the maximum dose that was individually well tolerated during the main part of the study in terms of the relative and absolute frequency and severity of GI AEs.\n\nSecondary Objectives:\n\nMain study and 6-month study extension period:\n\nTo assess in overweight to obese subjects and T2DM patients not requiring anti-diabetic pharmacotherapy:\n\n* The effect of once-daily dosing of SAR425899 on body weight (BW), fasting plasma glucose (FPG), and hemoglobin A1c (HbA1c).\n* Safety and tolerability.",[87],"Type 2 Diabetes Mellitus","COMPLETED","2022-04-22",{"date":91,"type":81},"2022-04-25",{"date":93,"type":81},"2018-01-19",{"date":95,"type":81},"2018-10-05",{"name":5,"class":6},3]