[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-hypercholesterolemia-or-mixed-hyperlipidemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-hypercholesterolemia-or-mixed-hyperlipidemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,58],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"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":19,"type":20},780,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Primary Hypercholesterolemia or Mixed Hyperlipidemia","NOT_YET_RECRUITING","2026-03-02",{"date":30,"type":31},"2026-03-04","ACTUAL",{"date":33,"type":20},"2026-03",{"date":35,"type":20},"2028-03",{"name":37,"class":38},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":4},"100627088","phase-3-qlc7401-monotherapy-in-non-familial-hypercholesterolemia-or-mixed-dyslipidemia-100627088","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.",{"count":47,"type":20},510,[23],"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.",[26],"2026-02-25",{"date":28,"type":31},{"date":54,"type":20},"2026-03-05",{"date":56,"type":20},"2028-02-28",{"name":37,"class":38},{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":21,"phases":67,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100573750","phase-2-study-of-qlc7401-in-the-treatment-of-primary-hypercholesterolemia-or-mixed-hyperlipidemia-with-elevated-ldl-cholesterol-100573750","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.",{"count":66,"type":20},156,[68],"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.",[26],"2024-12-19",{"date":73,"type":31},"2024-12-27",{"date":75,"type":20},"2025-02",{"date":77,"type":20},"2026-09",{"name":37,"class":38}]