[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603670":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":57,"collaborators":34,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":34,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":34,"enrollmentInfo":68,"targetDuration":34,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":34,"overallStatus":77,"whyStopped":34,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Guangdong Raynovent Biotech Co., Ltd","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"3mg RAY1225","EXPERIMENTAL","Participants received 3 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.",[13],"Drug: RAY1225",{"label":15,"type":10,"description":16,"interventionNames":17},"6mg RAY1225","Participants received 6 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"9mg RAY1225","Participants received 9 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"Placebo","PLACEBO_COMPARATOR","Participants received placebo as subcutaneous injection once every two week.",[27],"Drug: placebo",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","RAY1225","Administered SC",[9,15,19],null,{"type":30,"name":36,"description":32,"armGroupLabels":37,"otherNames":34},"placebo",[23],[39],{"name":40,"role":41,"phone":42,"phoneExt":34,"email":43},"JI professor","CONTACT","88326666","iao@pkuph.edu.cn",[45],{"facility":46,"status":34,"city":47,"state":48,"zip":34,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":34},"Peking University People's Hospital","Beijingcun","Hebei","China","CN",{"type":52,"coordinates":53},"Point",[54,55],119.10946,41.26103,{"lat":55,"lon":54},{"type":58,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100603670","phase-3-a-study-of-ray1225-in-participants-with-type-2-diabetes-not-controlled-with-diet-and-exercise-alone-100603670",false,"NCT07139535","A Study of RAY1225 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone","A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of RAY1225 Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone","Inclusion Criteria:\n\n1. Have been diagnosed with type 2 diabetes mellitus (T2DM)\n2. Having received only dietary and exercise therapy and never taken any antihyperglycemic medications before screening; OR Having taken no antihyperglycemic medications within the 12 weeks before screening and, prior to that, having received only oral antihyperglycemic drugs in a regimen of no more than two concomitant agents.\n3. Have a body mass index (BMI) ≥20 kilograms per meter squared (kg\u002Fm²) at screening\n4. Be of stable weight (±5%) for at least 12 weeks before screening\n\nExclusion Criteria:\n\n1. Have type 1 diabetes mellitus\n2. Presence of severe chronic diabetic complications at screening, including but not limited to: proliferative diabetic retinopathy, diabetic macular edema, and severe non-proliferative diabetic retinopathy requiring acute treatment;\n3. History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;\n4. Occurrence of a Grade 3 hypoglycemic event within 12 months prior to screening, or ≥3 Grade 2 hypoglycemic events (venous or capillary blood glucose \\\u003C3.0 mmol\u002FL) within 3 months prior to screening, or presence of hypoglycemia-related symptoms ;\n5. History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;\n6. Receipt of blood transfusion within 12 weeks prior to screening, or blood donation\u002Floss ≥400 mL within 12 weeks prior to screening, or blood donation\u002Floss ≥200 mL within 4 weeks prior to screening, or known hemoglobinopathy (such as thalassemia, hemolytic anemia, sickle cell anemia, etc.);\n7. Any unstable or treatment-requiring endocrine disorders related to glycemic control other than type 2 diabetes mellitus (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.).","ALL","18 Years",{"count":69,"type":70},350,"ESTIMATED","INTERVENTIONAL",[73],"PHASE3","The goal for this study is to evaluate the efficacy and safety of RAY1225 versus placebo in participants with type 2 diabetes not under control with diet and exercise alone.",[76],"T2DM","NOT_YET_RECRUITING","2025-08-17",{"date":80,"type":81},"2025-08-24","ACTUAL",{"date":83,"type":70},"2025-08-31",{"date":85,"type":70},"2026-12-31",{"name":5,"class":6},1]