[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573750":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":11,"studyPopulation":11,"armGroups":48,"interventions":69,"overallOfficials":11,"centralContacts":78,"locations":11,"responsibleParty":84,"collaborators":11,"id":86,"slug":11,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":11,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":11,"enrollmentInfo":94,"targetDuration":11,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":11,"overallStatus":103,"whyStopped":11,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"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 LDL-C from baseline to Day 180 and Day 270",null,"80 days and 270 days",[14,17,19,21,23,25,27,29,31,33,35],{"measure":15,"description":11,"timeFrame":16},"Percentage changes in LDL-C from baseline at each subsequent visit to Day 360","360 days",{"measure":18,"description":11,"timeFrame":16},"Value changes in LDL-C from baseline at each subsequent visit to Day 360",{"measure":20,"description":11,"timeFrame":16},"Percentage changes in PCSK9 from baseline at each subsequent visit to Day 360",{"measure":22,"description":11,"timeFrame":16},"Value changes in PCSK9 from baseline at each subsequent visit to Day 360",{"measure":24,"description":11,"timeFrame":16},"Percentage changes in non-HDL-C, Apo B, TC\u002FHDL-C, Apo A1, Apo B\u002FApo A1, Lp (a), and TG from baseline to Day 180, Day 270, and Day 360",{"measure":26,"description":11,"timeFrame":16},"Value changes in non-HDL-C, Apo B, TC\u002FHDL-C, Apo A1, Apo B\u002FApo A1, Lp (a), and TG from baseline to Day 180, Day 270, and Day 360",{"measure":28,"description":11,"timeFrame":16},"Proportion of participants with LDL-C greater than 80% of baseline value at Day 180, Day 210, Day 270, and Day 360",{"measure":30,"description":11,"timeFrame":16},"Duration of treatment for participants to return to 80% of baseline value or greater LDL-C or PCSK9 protein",{"measure":32,"description":11,"timeFrame":16},"Proportion of participants who attained global lipid modification targets for level of ASCVD risk",{"measure":34,"description":11,"timeFrame":16},"Number of participants with adverse events and injection site reactions, with abnormal vital signs, abnormal physical examination, abnormal 12-ECG, abnormal laboratory assessments",{"measure":36,"description":11,"timeFrame":16},"ADA incidence",{"allocation":38,"interventionModel":39,"interventionModelDescription":11,"primaryPurpose":40,"observationalModel":11,"timePerspective":11,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":11,"whoMasked":43},"QUADRUPLE",[44,45,46,47],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[49,55,59,63],{"label":50,"type":51,"description":52,"interventionNames":53},"QLC7401 100mg","EXPERIMENTAL","QLC7401 100 mg subcutaneous injection",[54],"Drug: QLC7401",{"label":56,"type":51,"description":57,"interventionNames":58},"QLC7401 300mg","QLC7401 300 mg subcutaneous injection",[54],{"label":60,"type":51,"description":61,"interventionNames":62},"QLC7401 500mg","QLC7401 500 mg subcutaneous injection",[54],{"label":64,"type":65,"description":66,"interventionNames":67},"Placebo","PLACEBO_COMPARATOR","Placebo 100\u002F300\u002F500 mg subcutaneous injection",[68],"Drug: Placebo",[70,75],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":11},"DRUG","QLC7401","QLC7401 combined with lipid-lowering agents",[50,56,60],{"type":71,"name":64,"description":76,"armGroupLabels":77,"otherNames":11},"Placebo combined with lipid-lowering agents",[64],[79],{"name":80,"role":81,"phone":82,"phoneExt":11,"email":83},"Ming Zhao","CONTACT","086+15666662408","ming.zhao@qilu-pharma.com",{"type":85,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":95,"type":96},156,"ESTIMATED","INTERVENTIONAL",[99],"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.",[102],"Primary Hypercholesterolemia or Mixed Hyperlipidemia","NOT_YET_RECRUITING","2024-12-19",{"date":106,"type":107},"2024-12-27","ACTUAL",{"date":109,"type":96},"2025-02",{"date":111,"type":96},"2026-09",{"name":5,"class":6}]