[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645349":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":11,"locations":37,"responsibleParty":49,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":11,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":11,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":11,"overallStatus":69,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Zhejiang Doer Biologics Co., Ltd.","INDUSTRY",[8,15,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group 1: Weekly DR10624 Injection","EXPERIMENTAL",null,[13,14],"Drug: DR10624 Subcutaneous Injection","Drug: Icosapent Ethyl Oral Capsule",{"label":16,"type":10,"description":11,"interventionNames":17},"Experimental Group 2: Weekly DR10624 Injection",[13,14],{"label":19,"type":20,"description":11,"interventionNames":21},"Weekly Matching Placebo Injection","PLACEBO_COMPARATOR",[14,22],"Drug: Matching Placebo Subcutaneous Injection",[24,29,33],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"DRUG","DR10624 Subcutaneous Injection","Weekly self-administered subcutaneous investigational biologic product, administered via autoinjector pen following standardized titration schedule throughout double-blind treatment phase.",[9,16],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"Icosapent Ethyl Oral Capsule","Fixed daily oral omega-3 lipid-lowering background therapy, maintained at consistent stable dose for all participants across all three study arms for full trial duration.",[9,16,19],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"Matching Placebo Subcutaneous Injection","Visually identical placebo autoinjector pen with inactive formulation, administered weekly following the identical titration timeline as active DR10624 groups to preserve double-blind status.",[19],[38],{"facility":39,"status":11,"city":40,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":11},"Peking University First Hospital","Beijing","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100645349","phase-3-a-phase-3-trial-of-dr10624-versus-placebo-in-patients-with-severe-hypertriglyceridemia-100645349",false,"NCT07680829","A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of DR10624 Added to Standard Icosapent Ethyl Therapy in Adults With Severe Hypertriglyceridemia","Inclusion Criteria:\n\n1. Age ≥18 years, male or female; BMI 19.0-45.0 kg\u002Fm², body weight ≥50 kg at screening.\n2. Fasting triglyceride (TG) range 5.65-22.60 mmol\u002FL: single screening lab result meets range, plus average of two separate fasting TG tests (interval \\>1 week) within same range prior to randomization.\n3. Stable lipid-lowering medications per local guidelines if on statin, cholesterol absorption inhibitor or PCSK9 inhibitor (minimum stable dose duration as required by drug class).\n4. Females of childbearing potential agree effective contraception from ICF signing to 2 months post last dose; male participants agree contraception and no sperm donation for 3 months post last dose.\n5. Able to understand study procedures, maintain consistent lifestyle and follow all protocol-specified requirements, and provide written informed consent.\n\nExclusion Criteria:\n\n1. Confirmed hereditary lipid disorders (Fredrickson Type 1\u002F3, Apo C-II deficiency).\n2. Significant weight loss or planned weight reduction during study.\n3. Severe chronic liver, renal or advanced cardiac disease.\n4. Uncontrolled diabetes or hypertension with severe complications.\n5. Pancreatitis history or symptomatic gallbladder disease.\n6. Recent major cardiovascular, bone or thyroid disorders.\n7. Severe psychiatric illness or substance abuse history.\n8. Prior GLP-1\u002FGCGR\u002FFGF21 agonists or other investigational drugs within 3 months.\n9. Abnormal screening lab parameters related to liver, pancreas, kidney or viral infection.\n10. Pregnant, breastfeeding or hypersensitivity to study treatments.\n11. Investigator's judgment of unsuitability for participation.","ALL","18 Years",{"count":61,"type":62},378,"ESTIMATED","INTERVENTIONAL",[65],"PHASE3","This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial for adults with severe hypertriglyceridemia whose lipid levels remain uncontrolled under standard Icosapent Ethyl background treatment plus lifestyle management. Eligible participants complete a screening run-in period, then randomize equally to three treatment groups: two active DR10624 subcutaneous injection groups and one placebo group. All subjects maintain fixed oral background lipid therapy throughout long-term double-blind treatment, followed by a short safety follow-up period. The primary objective is to evaluate the triglyceride-lowering effect of DR10624 versus placebo. Secondary assessments include other lipid indicators, liver fat content, overall safety, and anti-drug antibody status. Independent committees monitor interim data and adjudicate key clinical events to ensure participant safety.",[68],"Severe Hypertriglyceridemia","NOT_YET_RECRUITING","2026-07-01",{"date":72,"type":73},"2026-07-02","ACTUAL",{"date":75,"type":62},"2026-08",{"date":77,"type":62},"2030-10",{"name":5,"class":6},1]