[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601377":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":28,"studyPopulation":28,"armGroups":38,"interventions":70,"overallOfficials":28,"centralContacts":91,"locations":97,"responsibleParty":111,"collaborators":28,"id":113,"slug":28,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":28,"eligibilityCriteria":118,"healthyVolunteers":114,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":28,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":28,"overallStatus":100,"whyStopped":28,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in Hemoglobin A1c (HbA1c)","HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.","Baseline, Week 20",[14,18,21,25],{"measure":15,"description":16,"timeFrame":17},"Change from baseline in HbA1c","HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.","Baseline, Week 12",{"measure":19,"description":16,"timeFrame":20},"The percentage of patients reaching the HbA1c target of ≤6.5% and of ≤7.0%","Week 20",{"measure":22,"description":23,"timeFrame":24},"Change frome baseline in fasting plasma glucose (FPG)","FPG is a test to determine sugar levels in serum sample after an overnight fast.","Baseline, Week 12 and Week 20",{"measure":26,"description":27,"timeFrame":24},"Change from baseline in body weight","Change from baseline in body weight is calculated by subtracting the baseline weight measurement from the post-treatment weight measurement at a specified time point.",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":34,"maskingDescription":28,"whoMasked":35},"DOUBLE",[36,37],"PARTICIPANT","INVESTIGATOR",[39,45,50,54,58,64],{"label":40,"type":41,"description":42,"interventionNames":43},"Experimental group: HDM1005 1","EXPERIMENTAL","HDM1005 administered subcutaneously (SC)",[44],"Drug: HDM1005 1",{"label":46,"type":41,"description":47,"interventionNames":48},"Experimental group: HDM1005 2","HDM1005 administered SC",[49],"Drug: HDM1005 2",{"label":51,"type":41,"description":47,"interventionNames":52},"Experimental group: HDM1005 3",[53],"Drug: HDM1005 3",{"label":55,"type":41,"description":47,"interventionNames":56},"Experimental group: HDM1005 4",[57],"Drug: HDM1005 4",{"label":59,"type":60,"description":61,"interventionNames":62},"Placebo group","PLACEBO_COMPARATOR","Placebo administered SC",[63],"Drug: Placebo",{"label":65,"type":66,"description":67,"interventionNames":68},"Active Comparator: Dulaglutide","ACTIVE_COMPARATOR","Dulagutide administered SC",[69],"Drug: Dulaglutide 1.5 MG",[71,76,79,82,85,88],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":28},"DRUG","HDM1005 1","administered SC, QW, 20 weeks",[40],{"type":72,"name":77,"description":74,"armGroupLabels":78,"otherNames":28},"HDM1005 2",[46],{"type":72,"name":80,"description":74,"armGroupLabels":81,"otherNames":28},"HDM1005 3",[51],{"type":72,"name":83,"description":74,"armGroupLabels":84,"otherNames":28},"HDM1005 4",[55],{"type":72,"name":86,"description":74,"armGroupLabels":87,"otherNames":28},"Placebo",[59],{"type":72,"name":89,"description":74,"armGroupLabels":90,"otherNames":28},"Dulaglutide 1.5 MG",[65],[92],{"name":93,"role":94,"phone":95,"phoneExt":28,"email":96},"Lepeng Li","CONTACT","+86 18301051549","lilepeng@eastchinapharm.com",[98],{"facility":99,"status":100,"city":101,"state":102,"zip":28,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":28},"Peking University People's Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":106,"coordinates":107},"Point",[108,109],116.39723,39.9075,{"lat":109,"lon":108},{"type":112,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100601377",false,"NCT07109700","A Study of HDM1005 in Participants With T2DM Not Controlled With Diet\u002FExercise or Metformin","A Randomized, Double-blind, Placebo and Active Comparator-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HDM1005 in Subjects With T2DM With Inadequate Glycemic Control After Diet\u002FExercise or Metformin Therapy","Inclusion Criteria:\n\n* Confirmed as Type 2 Diabetes Mellitus (T2DM) for at least 24 weeks;\n* Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5%\n* Body Mass Index (BMI within the range of 22.5 \\~ 40.0 kg\u002Fm2\n\nExclusion Criteria:\n\n* Other types of diabetes besides T2DM\n* Acute complications of diabetes (such as diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketotic coma) occurred within 24 weeks prior to signing the Informed Consent Form (ICF)\n* History of a level 3 hypoglycemic episode or a history of asymptomatic hyp oglycemic episodes within 24 weeks prior to signing the ICF\n* History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2)\n* History of acute or chronic pancreatitis; or presence of risk factors for pancreatitis; or history of symptomatic gallbladder disease within 24 weeks prior to signing the ICF\n* Investigator determines that the subject has a condition or disease affecting gastric emptying or gastrointestinal nutrient absorption, such as weight-loss surgery or other gastric resections, irritable bowel syndrome, dyspepsia, or gastroparesis\n* Use of antidiabetic medications within 12 weeks prior to signing the ICF\n* Hemoglobin (Hb) \\\u003C100 g\u002FL (female) or \\\u003C110 g\u002FL (male)\n* FPG ≥13.9 mmol\u002FL\n* Aspartate aminotransferase (AST) \\>2.5× upper limit of normal (ULN) and\u002For alanine aminotransferase (ALT) \\>2.5× ULN\n* Total bilirubin \\>1.5× ULN\n* Fasting triglyceride (TG) \\>5.6 mmol\u002FL (500 mg\u002FdL)","ALL","18 Years","65 Years",{"count":123,"type":124},216,"ESTIMATED","INTERVENTIONAL",[127],"PHASE2","This study is a multicenter, randomized, double-blind (with open-label dose levels and active comparator), parallel-group, placebo- and active-controlled Phase 2 clinical trial aimed at evaluating the efficacy, safety, immunogenicity, and pharmacokinetic (PK) characteristics of HDM1005 in subjects with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control after diet\u002Fexercise or metformin therapy.\n\nA total of 216 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or \\>8.5%) and prior metformin use, then randomized 1:1:1:1:1:1 to: Group 1 (HDM1005 0.5 mg), Group 2 (HDM1005 1.0 mg), Group 3 (HDM1005 2.0 mg), Group 4 (HDM1005 3.0 mg), Group 5 (Placebo), and Group 6 (open-lable dulaglutide 1.5 mg, active comparator), with 36 subjects in each treatment group. Within each dose cohort (0.5\u002F1.0\u002F2.0\u002F3.0mg), there will be \\~45 total subjects (36 HDM1005 + 9 placebo). The 1.0mg, 2.0mg, and 3.0mg cohorts will implement dose titration.\n\nThe study consists of: 2-week screening, 20-week treatment, and 4-week safety follow-up. The end-of-study visit will be conducted 28 days after the last administration cycle.",[130],"Type 2 Diabetes","2025-08-12",{"date":133,"type":134},"2025-08-17","ACTUAL",{"date":136,"type":134},"2025-04-30",{"date":138,"type":124},"2026-02-28",{"name":5,"class":6},1]