[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628716":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":11,"responsibleParty":35,"collaborators":11,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":11,"eligibilityCriteria":43,"healthyVolunteers":44,"sex":45,"minAge":46,"maxAge":11,"enrollmentInfo":47,"targetDuration":11,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":11,"overallStatus":56,"whyStopped":11,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":11},{"fullName":5,"class":6},"CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SYH2053","EXPERIMENTAL",null,[13],"Drug: SYH2053 Injection",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo Injection",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","SYH2053 Injection","Administered by subcutaneous injection.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Placebo Injection","Administered by subcutaneous injection. The placebo is identical to SYH2053 Injection in appearance.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Clinical Trials Information Group officer","CONTACT","0311-69085587","ctr-contact@cspc.cn",{"type":36,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100628716","phase-3-a-study-to-evaluate-the-syh2053-injection-in-patients-with-heterozygous-familial-hypercholesterolemia-hefh-100628716",false,"NCT07465263","A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)","A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Trial","Inclusion Criteria:\n\n1. Male or female participants ≥18 years of age.\n2. HeFH.\n3. Stable moderate-to-high intensity statin therapy (± cholesterol absorption inhibitors) .\n4. Maintained a low-fat diet for ≥4 weeks before signing the ICF.\n5. Fasting LDL-C at screening ≥ 2.6 mmol\u002FL or ≥ 1.4 mmol\u002FL without ASCVD or with ASCVD.\n6. Fasting TG ≤5.6 mmol\u002FL at screening.\n\nExclusion Criteria:\n\n1. HoFH or suspected HoFH.\n2. Use of medications that significantly affect LDL-C levels.\n3. Hypersensitivity or suspected allergy to oligonucleotide drugs or excipients of the investigational product.\n4. Major adverse cardiovascular events (MACE) within 180 days before signing the ICF; history of hemorrhagic stroke; or extreme-risk ASCVD at screening.\n5. Uncontrolled (by medication\u002Fablation) or severe arrhythmias within 180 days before signing the ICF.\n6. NYHA Class III-IV heart failure or LVEF \\\u003C40% within 1 year before signing ICF or at screening.\n7. Type 1 diabetes.\n8. Uncontrolled severe illness or conditions that may interfere with study results\u002Fincrease risk at screening, according to investigator's judgment.\n9. History of malignancy or underlying malignancy within 5 years before signing ICF or at screening.\n10. Major surgery within 180 days before signing ICF or planned during the study.\n11. History of drug\u002Falcohol abuse within 5 years before signing ICF.\n12. Participation in another clinical trial within 90 days or 5 half-lives (whichever is longer) before signing ICF, or planned during the study.\n13. Any of the following at screening:\n\n1）SBP ≥160 mmHg or DBP ≥100 mmHg. 2）ALT\u002FAST \\>3× ULN, or total bilirubin \\>1.5× ULN. 3）CK \\>2.5× ULN. 4）QTcF interval: \\>450 ms for male, \\>470 ms for female. 5）eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m². 6）HBsAg positive with HBV DNA positive; or HCV\u002Fsyphilis\u002FHIV antibody positive. 7）TSH\\\u003CLLN, or TSH\\>ULN. 8）HbA1c \\>8.5%. 14.Pregnancy\u002Flactation or planned parenthood, and\u002For without effective contraception for female and male participants of childbearing potential from the study to 3 months after the end of treatment.\n\n\\-",true,"ALL","18 Years",{"count":48,"type":49},135,"ESTIMATED","INTERVENTIONAL",[52],"PHASE3","Heterozygous Familial Hypercholesterolemia (HeFH) is an autosomal dominant disorder characterized by markedly elevated low-density lipoprotein cholesterol (LDL-C) and increased risk of atherosclerotic cardiovascular disease (ASCVD). This trial aims to evaluate the SYH2053 Injection in patients with HeFH.",[55],"Heterozygous Familial Hypercholesterolemia (HeFH)","NOT_YET_RECRUITING","2026-03-17",{"date":59,"type":60},"2026-03-19","ACTUAL",{"date":62,"type":49},"2026-03-31",{"date":64,"type":49},"2028-05-31",{"name":5,"class":6}]