[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626875":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":11,"studyPopulation":11,"armGroups":34,"interventions":47,"overallOfficials":11,"centralContacts":56,"locations":11,"responsibleParty":62,"collaborators":11,"id":64,"slug":11,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":11,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":11,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":11,"overallStatus":81,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":11},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage changes in Low Density Lipoprotein Cholesterol (LDL-C)",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 Proprotein Convertase Subtilisin\u002FKexin type 9 (PCSK9) from Baseline","From baseline to Day 360",{"measure":21,"description":11,"timeFrame":22},"Incidence of Treatment-Emergent Adverse Events (TEAEs","Throughout the study duration]",{"allocation":24,"interventionModel":25,"interventionModelDescription":11,"primaryPurpose":26,"observationalModel":11,"timePerspective":11,"maskingInfo":27},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":28,"maskingDescription":11,"whoMasked":29},"QUADRUPLE",[30,31,32,33],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"QLC7401 Injection","EXPERIMENTAL","Participants receive QLC7401 at a pre-defined dosage via subcutaneous injection according to the study schedule.",[40],"Drug: QLC7401",{"label":42,"type":43,"description":44,"interventionNames":45},"Placebo","PLACEBO_COMPARATOR","Participants receive placebo via subcutaneous injection according to the study schedule.",[46],"Drug: Placebo",[48,53],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":11},"DRUG","QLC7401","QLC7401 combined with lipid-lowering agents",[36],{"type":49,"name":42,"description":54,"armGroupLabels":55,"otherNames":11},"Placebo combined with lipid-lowering agents",[42],[57],{"name":58,"role":59,"phone":60,"phoneExt":11,"email":61},"Jian an Wang, Doctorate","CONTACT","086-15990086511","wang_jian_an@vip.tom.com",{"type":63,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":73,"type":74},780,"ESTIMATED","INTERVENTIONAL",[77],"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.",[80],"Primary Hypercholesterolemia or Mixed Hyperlipidemia","NOT_YET_RECRUITING","2026-03-02",{"date":84,"type":85},"2026-03-04","ACTUAL",{"date":87,"type":74},"2026-03",{"date":89,"type":74},"2028-03",{"name":5,"class":6}]