[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573750":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":38,"locations":34,"responsibleParty":44,"collaborators":34,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":34,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":34,"enrollmentInfo":55,"targetDuration":34,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":34,"overallStatus":64,"whyStopped":34,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":34},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"QLC7401 100mg","EXPERIMENTAL","QLC7401 100 mg subcutaneous injection",[13],"Drug: QLC7401",{"label":15,"type":10,"description":16,"interventionNames":17},"QLC7401 300mg","QLC7401 300 mg subcutaneous injection",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"QLC7401 500mg","QLC7401 500 mg subcutaneous injection",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"Placebo","PLACEBO_COMPARATOR","Placebo 100\u002F300\u002F500 mg subcutaneous injection",[27],"Drug: Placebo",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","QLC7401","QLC7401 combined with lipid-lowering agents",[9,15,19],null,{"type":30,"name":23,"description":36,"armGroupLabels":37,"otherNames":34},"Placebo combined with lipid-lowering agents",[23],[39],{"name":40,"role":41,"phone":42,"phoneExt":34,"email":43},"Ming Zhao","CONTACT","086+15666662408","ming.zhao@qilu-pharma.com",{"type":45,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100573750","phase-2-study-of-qlc7401-in-the-treatment-of-primary-hypercholesterolemia-or-mixed-hyperlipidemia-with-elevated-ldl-cholesterol-100573750",false,"NCT06750341","Study of QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated LDL Cholesterol","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Different Doses of QLC7401 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia With Poorly Controlled Low-density Lipoprotein Cholesterol (LDL-C) Elevated on Optimized Lipid-lowering Therapy","Inclusion Criteria:\n\n* Male or female participants aged ≥18 years of age.\n* Serum LDL-C ≥1.8mmol\u002FL for ASCVD participants or ≥2.6mmol\u002FL for other participants at screening.\n* Fasting TG \\\u003C400mg\u002FdL (\\\u003C4.5mmol\u002FL) at screening.\n* Stable lipid-lowering therapy for ≥4 weeks at randomization.\n* Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.\n\nExclusion Criteria:\n\n* Having the following diseases or treatment history: (1) cardiac function as defined by the New York Heart Association (NYHA) grade II-IV at screening or randomization or latest detected LVEF\\\u003C30%; (2) CVD events within 3 months; (3) uncontrolled severe hypertension; (4) previous diagnosis of familial hypercholesterolemia; (5) have known allergic reaction to experimental drug, or have severe allergic reaction to other drugs; (6) inadequate organ functions or malignancy history; (7) prior exposure to other RNA inhibitors within 2 years.\n* Any of the laboratory indicators met the following criteria at screening or at randomization: (1) ALT or AST exceeding 2 times the upper limit of normal (ULN), or total bilirubin exceeding 1.5 times ULN; (2) creatine kinase (CK) exceeding 3 times ULN; (3) TSH is less than the lower limit or normal (LLN) or exceeds 1.5 times ULN.\n* General conditions: (1) male or female participants who do not agree to use high-efficiency contraceptives during the trial and for 6 months after the last dosing; (2) women who are pregnant or lactating.\n* The investigator determines that the participants have poor compliance or have any factors that may prevent them from participating in the study.","ALL","18 Years",{"count":56,"type":57},156,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2","To evaluate the efficacy, safety, pharmacodynamics and immunogenicity of QLC7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized lipid-lowering therapy.",[63],"Primary Hypercholesterolemia or Mixed Hyperlipidemia","NOT_YET_RECRUITING","2024-12-19",{"date":67,"type":68},"2024-12-27","ACTUAL",{"date":70,"type":57},"2025-02",{"date":72,"type":57},"2026-09",{"name":5,"class":6}]