[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"LIB Therapeutics LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100652673","phase-3-open-label-phase-3b-study-to-evaluate-the-long-term-efficacy-and-safety-of-lerodalcibep-in-children-and-adolescents-6-to-17-years-of-age-with-heterozygous-familial-hypercholesterolemia-on-stable-diet-and-oral-lipid-lowering-therapy-100652673",false,"NCT07775339","Open Label Phase 3b Study to Evaluate the Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents, 6 to 17 Years of Age, With Heterozygous Familial Hypercholesterolemia on Stable Diet and Oral Lipid-Lowering Therapy","Open Label Phase 3b Study to Evaluate the Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents, 6 to 17 Years of Age, With Heterozygous Familial Hypercholesterolemia on Stable Diet and Oral Lipid-Lowering Therapy (LIBerate-Kids OLE)","Inclusion Criteria:\n\nChildren and Adolescents, 6 to 17 Years of Age, with Heterozygous Familial Hypercholesterolemia who completed the LIB00-008 study\n\nExclusion Criteria:\n\nSubjects not completing the LIB00-008 study","ALL","6 Years","17 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal is to assess the long term efficacy (LDL cholesterol reduction) and safety over 3 years of lerodalcibep (Lerochol) SC 300 mg QM administered by auto-injector (AI)\u002Fpre-filled pen (PFP) in male and female pediatric patients 6 to 17 years of age, with inherited high cholesterol (HeFH) on a stable diet and maximally tolerated oral LDL C lowering drug therapy such as statins who completed the 24 week placebo controlled base trial.\n\nThe main question\\[s\\] it aims to answer are:\n\nHow effective is Lerochol in maintaining LDL cholesterol reductions over years? How well is it tolerated and are there any safety concerns?\n\nParticipants will visit the clinic every month for 3 months and then home dosed with clinic visits every 3 months. They will undergo periodic physical exams, height and weight measurements, answer questions, have blood drawn from a vein in their arm, have blood pressure measurements, EKC heart tests, and receive monthly injections lasting about 5 seconds in their arms or abdomen with an autoinjector.",[27],"Heterozygous Familial Hypercholesterolemia (HeFH)",[29,30,31,32,33],"PCSK9 inhibitor","LDL-C","HeFH","lerodalcibep","pediatric","NOT_YET_RECRUITING","2026-08-16",{"date":37,"type":38},"2026-08-20","ACTUAL",{"date":40,"type":21},"2027-01-20",{"date":42,"type":21},"2031-12-31",{"name":44,"class":45},"LIB Therapeutics LLC","INDUSTRY",5,""]