[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601377":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":45,"centralContacts":61,"locations":67,"responsibleParty":81,"collaborators":45,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":45,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":45,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":45,"overallStatus":70,"whyStopped":45,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.","INDUSTRY",[8,14,19,23,27,33],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group: HDM1005 1","EXPERIMENTAL","HDM1005 administered subcutaneously (SC)",[13],"Drug: HDM1005 1",{"label":15,"type":10,"description":16,"interventionNames":17},"Experimental group: HDM1005 2","HDM1005 administered SC",[18],"Drug: HDM1005 2",{"label":20,"type":10,"description":16,"interventionNames":21},"Experimental group: HDM1005 3",[22],"Drug: HDM1005 3",{"label":24,"type":10,"description":16,"interventionNames":25},"Experimental group: HDM1005 4",[26],"Drug: HDM1005 4",{"label":28,"type":29,"description":30,"interventionNames":31},"Placebo group","PLACEBO_COMPARATOR","Placebo administered SC",[32],"Drug: Placebo",{"label":34,"type":35,"description":36,"interventionNames":37},"Active Comparator: Dulaglutide","ACTIVE_COMPARATOR","Dulagutide administered SC",[38],"Drug: Dulaglutide 1.5 MG",[40,46,49,52,55,58],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DRUG","HDM1005 1","administered SC, QW, 20 weeks",[9],null,{"type":41,"name":47,"description":43,"armGroupLabels":48,"otherNames":45},"HDM1005 2",[15],{"type":41,"name":50,"description":43,"armGroupLabels":51,"otherNames":45},"HDM1005 3",[20],{"type":41,"name":53,"description":43,"armGroupLabels":54,"otherNames":45},"HDM1005 4",[24],{"type":41,"name":56,"description":43,"armGroupLabels":57,"otherNames":45},"Placebo",[28],{"type":41,"name":59,"description":43,"armGroupLabels":60,"otherNames":45},"Dulaglutide 1.5 MG",[34],[62],{"name":63,"role":64,"phone":65,"phoneExt":45,"email":66},"Lepeng Li","CONTACT","+86 18301051549","lilepeng@eastchinapharm.com",[68],{"facility":69,"status":70,"city":71,"state":72,"zip":45,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":45},"Peking University People's Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":76,"coordinates":77},"Point",[78,79],116.39723,39.9075,{"lat":79,"lon":78},{"type":82,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100601377","phase-2-a-study-of-hdm1005-in-participants-with-t2dm-not-controlled-with-dietexercise-or-metformin-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":94,"type":95},216,"ESTIMATED","INTERVENTIONAL",[98],"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.",[101],"Type 2 Diabetes","2025-08-12",{"date":104,"type":105},"2025-08-17","ACTUAL",{"date":107,"type":105},"2025-04-30",{"date":109,"type":95},"2026-02-28",{"name":5,"class":6},1]