[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626875":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":26,"responsibleParty":36,"collaborators":26,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":26,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":26,"enrollmentInfo":47,"targetDuration":26,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":26,"overallStatus":56,"whyStopped":26,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":26},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"QLC7401 Injection","EXPERIMENTAL","Participants receive QLC7401 at a pre-defined dosage via subcutaneous injection according to the study schedule.",[13],"Drug: QLC7401",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants receive placebo via subcutaneous injection according to the study schedule.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","QLC7401","QLC7401 combined with lipid-lowering agents",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Placebo combined with lipid-lowering agents",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Jian an Wang, Doctorate","CONTACT","086-15990086511","wang_jian_an@vip.tom.com",{"type":37,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100626875","phase-3-qlc7401-in-the-treatment-of-primary-hypercholesterolemia-or-mixed-hyperlipidemia-with-elevated-low-density-lipoprotein-cholesterol-ldl-c-100626875",false,"NCT07441317","QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated Low Density Lipoprotein Cholesterol (LDL-C)","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety 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\n1. Male or female participants aged ≥18 years of age.\n2. Serum low density lipoprotein cholesterol (LDL-C) ≥1.8mmol\u002FL for participants with atherosclerotic cardiovascular disease (ASCVD) or ≥2.6mmol\u002FL for other participants at screening.\n3. Fasting Total Cholesterol (TG) ≤400mg\u002FdL (≤4.5mmol\u002FL) at screening.\n4. Stable lipid-lowering therapy for ≥4 weeks at randomization.\n5. Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.\n\nExclusion Criteria:\n\n1. Having the following diseases or treatment history: (1) cardiac function as defined by the New York Heart Association (NYHA) grade III-IV at screening or randomization ; (2) Cardiovascular diseases 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.\n2. Any of the laboratory indicators met the following criteria at screening or at randomization: (1) ALT or AST exceeding 3 times the upper limit of normal (ULN), or total bilirubin exceeding 2 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.\n3. 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.\n4. 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":48,"type":49},780,"ESTIMATED","INTERVENTIONAL",[52],"PHASE3","To evaluate the efficacy, safety and immunogenicity of QCL7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized lipid-lowering therapy.",[55],"Primary Hypercholesterolemia or Mixed Hyperlipidemia","NOT_YET_RECRUITING","2026-03-02",{"date":59,"type":60},"2026-03-04","ACTUAL",{"date":62,"type":49},"2026-03",{"date":64,"type":49},"2028-03",{"name":5,"class":6}]