[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643631":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":39,"studyPopulation":11,"armGroups":40,"interventions":59,"overallOfficials":11,"centralContacts":70,"locations":11,"responsibleParty":76,"collaborators":11,"id":78,"slug":11,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":11,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":11,"enrollmentInfo":86,"targetDuration":11,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":11,"overallStatus":95,"whyStopped":11,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":11},{"fullName":5,"class":6},"CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage change in Lp(a) from baseline to Day 60~180",null,"Day 60~180",[14,17,19,21,23,26,28],{"measure":15,"description":11,"timeFrame":16},"Percentage change in Lp(a) from baseline to Day 30~540","Day 30~540",{"measure":18,"description":11,"timeFrame":16},"The percentage of participants achieving Lp(a) \u003C 125 nmol\u002FL and \u003C75 nmol\u002FL.",{"measure":20,"description":11,"timeFrame":16},"Changes of LDL-C from baseline to Day 30~540",{"measure":22,"description":11,"timeFrame":16},"Changes of ApoB from baseline to Day 30~540",{"measure":24,"description":11,"timeFrame":25},"Incidence of TEAEs during the treatment","During treatment",{"measure":27,"description":11,"timeFrame":25},"ADA incidence",{"measure":29,"description":11,"timeFrame":25},"The plasma concentration of SYH2068.",{"allocation":31,"interventionModel":32,"interventionModelDescription":11,"primaryPurpose":33,"observationalModel":11,"timePerspective":11,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":11,"whoMasked":36},"DOUBLE",[37,38],"PARTICIPANT","INVESTIGATOR","This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase II clinical trial aimed at evaluating the efficacy, safety, immunogenicity, and pharmacokinetic characteristics of SYH2068 injection in adult participants with elevated lipoprotein(a). The study consists of a screening period and a treatment period.",[41,46,50,54],{"label":42,"type":43,"description":11,"interventionNames":44},"SYH2068 Dose 1","EXPERIMENTAL",[45],"Drug: SYH2068 Dose 1",{"label":47,"type":43,"description":11,"interventionNames":48},"SYH2068 Dose 2",[49],"Drug: SYH2068 Dose 2",{"label":51,"type":43,"description":11,"interventionNames":52},"SYH2068 Dose 3",[53],"Drug: SYH2068 Dose 3",{"label":55,"type":56,"description":11,"interventionNames":57},"Placebo","PLACEBO_COMPARATOR",[58],"Drug: Placebo",[60,64,66,68],{"type":61,"name":42,"description":62,"armGroupLabels":63,"otherNames":11},"DRUG","Administered by subcutaneous injection.",[42],{"type":61,"name":47,"description":62,"armGroupLabels":65,"otherNames":11},[47],{"type":61,"name":51,"description":62,"armGroupLabels":67,"otherNames":11},[51],{"type":61,"name":55,"description":62,"armGroupLabels":69,"otherNames":11},[55],[71],{"name":72,"role":73,"phone":74,"phoneExt":11,"email":75},"Clinical Trials Information Group officer","CONTACT","0311-69085587","ctr-contact@cspc.cn",{"type":77,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100643631",false,"NCT07640217","A Phase II Clinical Study of SYH2068 Injection in Adults With Elevated Lipoprotein(a)","A Phase II Randomized, Double-Blind, Parallel-group, Placebo-Controlled Trial of SYH2068 Injection in Adults With Elevated Lipoprotein(a)","Inclusion Criteria:\n\n1. Male or female participants ≥18 years of age;\n2. Elevated Lp(a);\n3. Participants who have used lipid-lowering drugs continue to use a stable dose, and those who have not used do not start new lipid-lowering drugs;\n4. Presence of ASCVD or ASCVD risk stratification assessed as moderate or high risk;\n5. Participants are able to understand and cooperate to complete this study, voluntarily participate in this study, and sign the ICF.\n\nExclusion Criteria:\n\n1. Diseases that significantly affect Lp(a) during screening period,\n2. Major or unstable cardiovascular events occurring from 3 months before signing the ICF to randomization;\n3. Undergoing or expected to undergo peripheral arterial, coronary, or cerebrovascular revascularization surgery or other major surgery within 3 months prior to signing the ICF until randomization or during the study period;\n4. NYHA class III-IV at the time of signing the ICF or LVEF \\\u003C40% during the screening period;\n5. Type 1 diabetes or hereditary hemorrhagic disorder at screening;\n6. History of malignant tumor or suspected malignancy within 5 years prior to screening;\n7. Use of drugs affecting Lp(a) within the specified period before screening or expected to use during the study period;\n8. Allergy to oligonucleotide drugs;\n9. Received any other clinical study treatment within 3 months prior to screening or within 5 half-lives of the investigational drug;\n10. Female participants who are pregnant or breastfeeding at screening, or female \u002F male participants who plan to conceive during the study and within 1 year after the last dose.","ALL","18 Years",{"count":87,"type":88},120,"ESTIMATED","INTERVENTIONAL",[91],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of SYH2068 injection in patients with elevated lipoprotein(a).",[94],"Adult Participants With Elevated Lipoprotein(a)","NOT_YET_RECRUITING","2026-06-05",{"date":98,"type":99},"2026-06-10","ACTUAL",{"date":101,"type":88},"2026-07-30",{"date":103,"type":88},"2028-09-30",{"name":5,"class":6}]