[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597589":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":11,"centralContacts":34,"locations":40,"responsibleParty":59,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":11,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":11,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Fujian Shengdi Pharmaceutical Co., Ltd.","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group A: HRS9531-low dose","EXPERIMENTAL",null,[13],"Drug: HRS9531",{"label":15,"type":10,"description":11,"interventionNames":16},"Treatment group B: HRS9531-high dose",[13],{"label":18,"type":19,"description":11,"interventionNames":20},"Treatment group C","PLACEBO_COMPARATOR",[21],"Drug: Placebo",[23,28,31],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"DRUG","HRS9531","HRS9531-low dose",[9],{"type":24,"name":25,"description":29,"armGroupLabels":30,"otherNames":11},"HRS9531-high dose",[15],{"type":24,"name":32,"description":32,"armGroupLabels":33,"otherNames":11},"Placebo",[18],[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Hong Chen","CONTACT","+86-0518-82342973","hong.chen@hengrui.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Perking University Peoples' Hospital","RECRUITING","Beijing","Beijing Municipality","100044","China","CN",{"type":50,"coordinates":51},"Point",[52,53],116.39723,39.9075,{"lat":53,"lon":52},[56],{"name":57,"role":58,"phone":11,"phoneExt":11,"email":11},"Linong JI","PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100597589","phase-3-efficacy-and-safety-of-hrs9531-in-participants-with-type-2-diabetes-treated-with-basal-insulin-100597589",false,"NCT07060456","Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin","A Phase III, Multicenter, Randomized, Double Blinded, Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin.","Inclusion Criteria:\n\n1. Male or female, able and willing to provide a written informed consent\n2. Diagnosed with type 2 diabetes ≥ 90 days；\n3. On stable once-daily dose of basal insulin alone or in combination with metformin and\u002For SGLT2 inhibitor ≥ 90 days;\n4. HbA1c was 7.5%\\~11.0% (both inclusive);\n5. Body Mass Index (BMI) ≥22 kg\u002Fm2 at screening.\n\nExclusion Criteria:\n\n1. A history of type 1 diabetes, specific diabetes, or secondary diabetes;\n2. Have a history of severe hypoglycemia within t180 days prior to screening;\n3. History of acute cardiovascular and cerebrovascular diseases within 180 days prior to screening；\n4. Have a history of malignancy within 5 years;\n5. Known or suspected allergy or intolerance to the investigational medicinal products or related products;\n6. Participation in any clinical trial of an approved or non-approved investigational product\u002Ftreatment within the last 90 days;\n7. Any conditions that the Investigator judges might not be suitable to participate in the trial.","ALL","18 Years",{"count":71,"type":72},300,"ESTIMATED","INTERVENTIONAL",[75],"PHASE3","The study is being conducted to evaluate the efficacy and safety of HRS9531 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and\u002For sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.",[78],"Type 2 Diabetes","2025-12-28",{"date":81,"type":82},"2026-01-02","ACTUAL",{"date":84,"type":82},"2025-07-25",{"date":86,"type":72},"2027-03",{"name":5,"class":6},1]