[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658360":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":11,"studyPopulation":11,"armGroups":53,"interventions":72,"overallOfficials":11,"centralContacts":80,"locations":86,"responsibleParty":109,"collaborators":11,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":11,"eligibilityCriteria":117,"healthyVolunteers":113,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":11,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":11,"overallStatus":130,"whyStopped":11,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Zhejiang Doer Biologics Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage change from baseline in fasting serum triglyceride concentration at Week 26",null,"Baseline up to Week 26 of double-blind treatment period",[14,17,20,23,26,29,32,36,39],{"measure":15,"description":15,"timeFrame":16},"Percentage change in fasting TG from baseline","From first study drug injection through the end of treatment (up to 64 weeks)",{"measure":18,"description":19,"timeFrame":16},"Percentage change in lipid profile from baseline","The change from baseline in the following lipid parameters will be assessed: total cholesterol (TC), non-high-density lipoprotein cholesterol (non-HDL-C), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), small dense low-density lipoprotein cholesterol (sdLDL-C), very low-density lipoprotein cholesterol (VLDL-C), triglyceride-rich lipoprotein cholesterol (TRL-C), and free fatty acids (FFA).",{"measure":21,"description":22,"timeFrame":16},"Change in urine albumin-to-creatinine ratio (UACR) from baseline","Percentage change in urine albumin-to-creatinine ratio (UACR) from baseline",{"measure":24,"description":25,"timeFrame":16},"Change in eGFR from baseline","The absolute change and percentage change in estimated glomerular filtration rate from baseline",{"measure":27,"description":28,"timeFrame":16},"Change in Liver Fat Content (LFC) Measured by MRI-PDFF","The absolute change and percentage change in LFC from baseline measured by MRI-PDFF",{"measure":27,"description":30,"timeFrame":31},"The percentage of participants with ≥30% relative reduction in liver fat content (LFC) from baseline, ≥50% relative reduction in LFC from baseline, or absolute LFC \\\u003C 5%,","From baseline to Week 26",{"measure":33,"description":34,"timeFrame":35},"Proportion of participants with treatment-emergent adverse events (TEAEs) throughout the study","All adverse events emerging from the first study drug injection until 4 weeks after the last injection are captured, coded by MedDRA and graded per pre-defined severity criteria. The percentage of participants experiencing any TEAE and the distribution of maximum TEAE severity will be summarized for the full safety observation window.","First study drug injection through 4-week post-treatment safety follow-up",{"measure":37,"description":38,"timeFrame":35},"Serum concentration of DR10624","Pharmacokinetic assessment: serum DR10624 concentration at scheduled sampling time points",{"measure":40,"description":41,"timeFrame":35},"Positive rate of anti-drug antibody (ADA) against DR10624","Positive rate of ADA against DR10624",{"allocation":43,"interventionModel":44,"interventionModelDescription":11,"primaryPurpose":45,"observationalModel":11,"timePerspective":11,"maskingInfo":46},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":47,"maskingDescription":11,"whoMasked":48},"QUADRUPLE",[49,50,51,52],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[54,60,63,66],{"label":55,"type":56,"description":57,"interventionNames":58},"Dose 1 DR10624 Group","EXPERIMENTAL","Subcutaneous injection of DR10624 once weekly",[59],"Drug: DR10624 Injection",{"label":61,"type":56,"description":57,"interventionNames":62},"Dose 2 DR10624 Group",[59],{"label":64,"type":56,"description":57,"interventionNames":65},"Dose 3 DR10624 Group",[59],{"label":67,"type":68,"description":69,"interventionNames":70},"Placebo Group","PLACEBO_COMPARATOR","Subcutaneous injection of placebo once weekly",[71],"Drug: Placebo",[73,77],{"type":74,"name":75,"description":75,"armGroupLabels":76,"otherNames":11},"DRUG","DR10624 Injection",[55,61,64],{"type":74,"name":78,"description":78,"armGroupLabels":79,"otherNames":11},"Placebo",[67],[81],{"name":82,"role":83,"phone":84,"phoneExt":11,"email":85},"Yongliang Fang","CONTACT","+86 057128256206","yf@dorebio.com",[87,101],{"facility":88,"status":11,"city":89,"state":11,"zip":11,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Peking University First Hospital","Beijing","China","CN",{"type":93,"coordinates":94},"Point",[95,96],116.39723,39.9075,{"lat":96,"lon":95},[99],{"name":100,"role":83,"phone":11,"phoneExt":11,"email":11},"Minghui Zhao",{"facility":102,"status":11,"city":89,"state":11,"zip":11,"country":90,"countryCode":91,"cosmosGeoPoint":103,"geoPoint":105,"contacts":106},"Peking University Third Hospital",{"type":93,"coordinates":104},[95,96],{"lat":96,"lon":95},[107],{"name":108,"role":83,"phone":11,"phoneExt":11,"email":11},"Yida Tang",{"type":110,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100658360","phase-2-a-phase-2-study-to-evaluate-the-efficacy-and-safety-of-dr10624-in-subjects-with-moderate-hypertriglyceridemia-and-diabetic-kidney-disease-100658360",false,"NCT07848880","A Phase 2 Study to Evaluate the Efficacy and Safety of DR10624 in Subjects With Moderate Hypertriglyceridemia and Diabetic Kidney Disease","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate the Efficacy and Safety of Multiple Doses of DR10624 in Subjects With Moderate Hypertriglyceridemia and Diabetic Kidney Disease","Inclusion Criteria:\n\n1. Male or female participants, aged 18 to 75 years at screening.\n2. BMI 19.0-45.0 kg\u002Fm², body weight ≥50.0 kg.\n3. At least two triglyceride measurements of ≥2.3 mmol\u002FL and \\\u003C5.7 mmol\u002FL during the screening period, with an interval of more than 1 week between the two measurements.\n4. Diagnosis of type 2 diabetes mellitus for ≥12 weeks, with stable doses of glucose-lowering medication(s) for ≥8 weeks.\n5. Meets the diagnostic criteria for diabetic kidney disease as defined in relevant guidelines.\n6. eGFR and UACR meet the thresholds specified in the protocol.\n7. On stable doses of renoprotective medication for ≥4 weeks.\n8. Able to understand study procedures, maintain consistent lifestyle and follow all protocol-specified requirements, and provide written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosed with non-diabetic kidney disease ，history of or planned kidney transplantation，solitary kidney ；or recent dialysis due to acute renal insufficiency.\n2. History of NYHA Class III-IV heart failure, obstructive valvular heart disease, or hypertrophic cardiomyopathy; uncontrolled hypertension or severe arrhythmia.\n3. Recent acute coronary syndrome or cardiac surgery，severe diabetic events or ocular complications or bone disorders.\n4. Unqualified laboratory results at screening: abnormal liver or pancreatic function indexes, elevated HbA1c, elevated calcitonin, or positive HIV\u002FHBV\u002FHCV serology.\n5. Prior exposure to GLP-1R, GCGR, or FGF21R agonists; use of relevant investigational drugs or participation in other interventional trials within 3 months; or use of DPP-4 inhibitors within 4 weeks.\n6. History of acute pancreatitis, chronic pancreatitis or symptomatic gallbladder disease.\n7. Severe psychiatric disorders, substance abuse, family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)or malignancy within the past 5 years.\n8. Lipid-lowering medications or medications that may exacerbate hypertriglyceridemia have not been at a stable dose for a sufficient duration.\n9. Pregnancy or lactation; refusal to use contraception; known hypersensitivity to the study drug; or any condition that, in the investigator's judgment, makes the participant unsuitable for the study.","ALL","18 Years","75 Years",{"count":122,"type":123},315,"ESTIMATED","INTERVENTIONAL",[126],"PHASE2","This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial in adults with moderate hypertriglyceridemia and diabetic kidney disease. Eligible participants complete a screening period and then randomized to four treatment groups: three active-dose groups of subcutaneous DR10624 and one placebo group. All groups receive weekly subcutaneous injections for a total of 64 weeks of double-blind treatment, followed by a 4-week post-treatment safety follow-up. The primary objective is to evaluate the triglyceride-lowering effect of DR10624 versus placebo. Secondary assessments include other lipid parameters, renal parameters, hepatic fat fraction, overall safety, and anti-drug antibody status.",[129],"Hypertriglyceridemia","NOT_YET_RECRUITING","2026-09-24",{"date":133,"type":134},"2026-09-30","ACTUAL",{"date":136,"type":123},"2026-10",{"date":138,"type":123},"2029-03",{"name":5,"class":6},2]