[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646134":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":35,"centralContacts":40,"locations":46,"responsibleParty":60,"collaborators":29,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":29,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":29,"enrollmentInfo":71,"targetDuration":29,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":96,"whyStopped":29,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Zhejiang Doer Biologics Co., Ltd.","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose 1 DR10624 Group","EXPERIMENTAL","Subcutaneous injection of DR10624 once weekly.",[13],"Biological: DR10624 Injection",{"label":15,"type":10,"description":11,"interventionNames":16},"Dose 2 DR10624 Group",[13],{"label":18,"type":19,"description":20,"interventionNames":21},"Placebo Group","PLACEBO_COMPARATOR","Subcutaneous injection of placebo once weekly.",[22],"Other: Matching Placebo for DR10624",[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BIOLOGICAL","DR10624 Injection","Novel investigational biologic agent for severe hypertriglyceridemia, administered via weekly subcutaneous injection with two titrated dose regimens (low-dose and high-dose) for 64 weeks double-blind treatment period.",[9,15],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"OTHER","Matching Placebo for DR10624","Volume-matched inert subcutaneous injection placebo, visually identical to DR10624 to maintain double-blind masking for all study participants.",[18],[36],{"name":37,"affiliation":38,"role":39},"Junbo Ge","Shanghai Zhongshan Hospital","STUDY_CHAIR",[41],{"name":42,"role":43,"phone":44,"phoneExt":29,"email":45},"Yongliang Fang","CONTACT","+86 057128256206","yf@dorebio.com",[47],{"facility":48,"status":29,"city":49,"state":29,"zip":29,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Zhongshan Hospital","Shanghai","China","CN",{"type":53,"coordinates":54},"Point",[55,56],121.45806,31.22222,{"lat":56,"lon":55},[59],{"name":37,"role":43,"phone":29,"phoneExt":29,"email":29},{"type":61,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100646134","phase-3-a-phase-iii-study-to-evaluate-the-efficacy-and-safety-of-of-dr10624-in-subjects-with-severe-hypertriglyceridemia-100646134",false,"NCT07693777","A Phase III Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy and Safety of DR10624 in Subjects With Severe Hypertriglyceridemia Receiving Stable Lipid-Modifying Therapy","Inclusion Criteria:\n\n1. Male or female aged ≥18 years at screening.\n2. BMI 19.0-45.0 kg\u002Fm², body weight ≥50.0 kg.\n3. Fasting triglyceride meets protocol-specified threshold at local lab and average of two separate central lab fasting samples collected ≥1 week apart.\n4. On stable guideline lipid-lowering therapy ≥4 weeks.\n5. Able to follow protocol and maintain stable lifestyle; sign voluntary written informed consent.\n\nExclusion Criteria:\n\n1. Confirmed\u002Fsuspected familial severe hypertriglyceridemia subtypes (Fredrickson Type 1\u002F3, ApoC-II deficiency).\n2. Unstable body weight, severe liver\u002Fkidney disease, uncontrolled diabetes or hypertension, NYHA III-IV heart failure, Cushing syndrome.\n3. History of acute pancreatitis within 6 months, chronic pancreatitis or symptomatic gallbladder disease.\n4. Recent major cardiovascular events, bone disorders, abnormal thyroid function or active malignancy within 5 years.\n5. Severe psychiatric disorders, substance abuse\u002Fexcessive alcohol intake, or MTC\u002FMEN2 family\u002Fpersonal history.\n6. Prior exposure to GLP-1R\u002FGCGR\u002FFGF21R agonists, relevant investigational drugs or other interventional trials within 3 months.\n7. Unqualified lab results at screening: abnormal liver\u002Fpancreas\u002Frenal indexes, elevated HbA1c, positive HIV\u002FHBV\u002FHCV, severe arrhythmia.\n8. Pregnancy\u002Flactation, contraception refusal, hypersensitivity to study drug, blood donation ≥400mL recently, or any conditions judged by investigator to affect trial safety\u002Fefficacy.","ALL","18 Years",{"count":72,"type":73},480,"ESTIMATED","INTERVENTIONAL",[76],"PHASE3","This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial to assess the efficacy and safety of weekly subcutaneous DR10624 injection in adult patients with severe hypertriglyceridemia (sHTG). Eligible participants have persistently elevated fasting triglycerides despite stable background lipid-lowering therapy. Subjects will be randomized at a 2:2:1 ratio to three treatment arms: DR10624 low dose, DR10624 high dose, or matching placebo, receiving weekly subcutaneous injections for a total of 64 weeks double-blind treatment, followed by a 4-week post-treatment safety follow-up. The primary goal is to evaluate the percentage reduction in fasting triglycerides at Week 26. Secondary assessments include changes in ApoC3, remnant cholesterol, liver fat content measured by MRI-PDFF, incidence of adjudicated acute pancreatitis, and overall safety profile including treatment-emergent adverse events and immunogenicity.",[79,80],"Severe Hypertriglyceridemia (sHTG)","Hypertriglyceridemia",[82,83,84,85,86,87,88,89,90,91,92,93,94,95],"Severe hypertriglyceridemia","hypertriglyceridemia","triglyceride","Apolipoprotein C3","remnant cholesterol","nonalcoholic fatty liver disease","MRI-PDFF","acute pancreatitis","DR10624","subcutaneous injection","lipid lowering therapy","phase 3 clinical trial","investigational new drug","hyperlipidemia","NOT_YET_RECRUITING","2026-07-08",{"date":99,"type":100},"2026-07-10","ACTUAL",{"date":102,"type":73},"2026-08-17",{"date":104,"type":73},"2029-12-05",{"name":5,"class":6},1]