[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627572":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":11,"responsibleParty":33,"collaborators":11,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":11,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"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 Injection","EXPERIMENTAL",null,[13],"Drug: QLC7401 Injection",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","QLC7401 is a small interfering RNA (siRNA) targeting PCSK9. Administered as subcutaneous injection at a specified dose level.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Placebo matching QLC7401 in appearance and administration.",[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Jie Lin, PhD","CONTACT","86 135 2183 6273","Linjie1998@126.com",{"type":34,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100627572","phase-3-qlc7401-in-participants-with-heterozygous-familial-hypercholesterolemia-hefh-100627572",false,"NCT07450378","QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)","Evaluation of Efficacy and Safety of QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia on a Stable Lipid-lowering Therapy: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study","Inclusion Criteria:\n\n* Aged 18-80 years (inclusive)\n* Participants diagnosed with heterozygous familial hypercholesterolemia by Dutch Lipid Clinic\n* Network criteria or genetic testing;\n* Serum low density lipoprotein cholesterol ≥2.6 millimoles (mmol)\u002Fliter (L) at screening.\n* Fasting triglyceride \\\u003C4.5 mmol\u002FL at screening.\n* Participants on lipid-lowering therapies should be on a stable dose for ≥4 weeks before screening with no planned medication or dose change during study participation.\n* Estimated glomerular filtration Rate (eGFR) \\>30 mL\u002Fmin\u002F1.73 m².\n* Willing to provide informed consent.\n\nExclusion Criteria:\n\n* New York Heart Association (NYHA) class III or IV heart failure.\n* Uncontrolled cardiac arrhythmia.\n* Cardiovascular Diseases within 3 months.\n* Uncontrolled hypertension.\n* Poorly controlled type 2 diabetes.\n* Significant liver or kidney disease.\n* Pregnancy or lactation.\n* Other conditions deemed unsuitable by investigator.","ALL","18 Years","80 Years",{"count":46,"type":47},120,"ESTIMATED","INTERVENTIONAL",[50],"PHASE3","This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 Treatment in adults with Heterozygous Familial Hypercholesterolemia on a stable lipid-lowering therapy. Participants will be randomly assigned to receive subcutaneous injections of either QLC7401 or a placebo according to the study schedule.",[53],"Heterozygous Familial Hypercholesterolemia (HeFH)","NOT_YET_RECRUITING","2026-02-27",{"date":57,"type":58},"2026-03-04","ACTUAL",{"date":60,"type":47},"2026-05",{"date":62,"type":47},"2028-07",{"name":5,"class":6}]