[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627088":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":11,"responsibleParty":34,"collaborators":11,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":11,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":11,"enrollmentInfo":45,"targetDuration":11,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":11,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":11},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"QLC7401","EXPERIMENTAL",null,[13],"Drug: QLC7401",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo Group","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","QLC7401 Injection",[9],{"type":21,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Placebo","Placebo matching QLC7401 in appearance and administration.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Yue Li, PhD","CONTACT","8613945057313","hydy_liyue@163.com",{"type":35,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100627088","phase-3-qlc7401-monotherapy-in-non-familial-hypercholesterolemia-or-mixed-dyslipidemia-100627088",false,"NCT07444086","QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia","Evaluation of Efficacy and Safety of QLC7401 Monotherapy in Participants With Non-familial Primary Hypercholesterolemia or Mixed Dyslipidemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study","Inclusion Criteria:\n\n* Aged ≥18 years.\n* Fasting low density lipoprotein cholesterol (LDL-C) ≥2.6 mmol\u002FL and \\\u003C4.9 mmol\u002FL at screening.\n* Atherosclerotic cardiovascular disease (ASCVD) risk stratification as low or intermediate risk per Chinese guidelines.\n* Not currently on lipid-lowering therapy.\n* estimated Glomerular Filtration Rate (eGFR) \\>30 mL\u002Fmin\u002F1.73 m².\n* Willing to provide informed consent.\n\nExclusion Criteria:\n\n* History of AAtherosclerotic cardiovascular disease (ASCVD)(e.g., myocardial infarction, stroke).\n* Familial hypercholesterolemia.\n* Uncontrolled hypertension (Systolic Blood Pressure ≥160 mmHg or (Diastolic Blood Pressure ≥100 mmHg).\n* Poorly controlled type 2 diabetes (Glycated Haemoglobin A1c \\>8.0%).\n* Use of prohibited lipid-lowering drugs within specified washout periods.\n* Significant liver or kidney disease.\n* Pregnancy or lactation.\n* Other conditions deemed unsuitable by investigator.","ALL","18 Years",{"count":46,"type":47},510,"ESTIMATED","INTERVENTIONAL",[50],"PHASE3","This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 monotherapy in adults with non-familial primary hypercholesterolemia or mixed dyslipidemia who are not receiving lipid-lowering therapy. Participants will be randomly assigned to receive subcutaneous injections of either QLC7401 or a placebo according to the study schedule.",[53],"Primary Hypercholesterolemia or Mixed Hyperlipidemia","NOT_YET_RECRUITING","2026-02-25",{"date":57,"type":58},"2026-03-02","ACTUAL",{"date":60,"type":47},"2026-03-05",{"date":62,"type":47},"2028-02-28",{"name":5,"class":6}]