[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627088":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":11,"studyPopulation":11,"armGroups":33,"interventions":44,"overallOfficials":11,"centralContacts":53,"locations":11,"responsibleParty":59,"collaborators":11,"id":61,"slug":11,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":11,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":11,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":11,"overallStatus":78,"whyStopped":11,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":11},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline",null,"From baseline to Day 330",[14,17,20],{"measure":15,"description":11,"timeFrame":16},"Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)","Day 90 to Day 360",{"measure":18,"description":11,"timeFrame":19},"Change in concentration of Proprotein Convertase Subtilisin\u002FKexin type 9 (PCSK9) from Baseline","From baseline to Day 360",{"measure":21,"description":11,"timeFrame":19},"Incidence of Treatment-Emergent Adverse Events (TEAEs)",{"allocation":23,"interventionModel":24,"interventionModelDescription":11,"primaryPurpose":25,"observationalModel":11,"timePerspective":11,"maskingInfo":26},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":11,"whoMasked":28},"QUADRUPLE",[29,30,31,32],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[34,39],{"label":35,"type":36,"description":11,"interventionNames":37},"QLC7401","EXPERIMENTAL",[38],"Drug: QLC7401",{"label":40,"type":41,"description":11,"interventionNames":42},"Placebo Group","PLACEBO_COMPARATOR",[43],"Drug: Placebo",[45,49],{"type":46,"name":35,"description":47,"armGroupLabels":48,"otherNames":11},"DRUG","QLC7401 Injection",[35],{"type":46,"name":50,"description":51,"armGroupLabels":52,"otherNames":11},"Placebo","Placebo matching QLC7401 in appearance and administration.",[40],[54],{"name":55,"role":56,"phone":57,"phoneExt":11,"email":58},"Yue Li, PhD","CONTACT","8613945057313","hydy_liyue@163.com",{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":70,"type":71},510,"ESTIMATED","INTERVENTIONAL",[74],"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.",[77],"Primary Hypercholesterolemia or Mixed Hyperlipidemia","NOT_YET_RECRUITING","2026-02-25",{"date":81,"type":82},"2026-03-02","ACTUAL",{"date":84,"type":71},"2026-03-05",{"date":86,"type":71},"2028-02-28",{"name":5,"class":6}]