[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610680":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":11,"centralContacts":33,"locations":39,"responsibleParty":58,"collaborators":11,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":11,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":11,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":11,"overallStatus":42,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Beijing Suncadia Pharmaceuticals Co., Ltd","INDUSTRY",[8,14,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-1918 low dose","EXPERIMENTAL",null,[13],"Drug: SHR-1918",{"label":15,"type":16,"description":11,"interventionNames":17},"SHR-1918 placebo low dose","PLACEBO_COMPARATOR",[18],"Drug: SHR-1918 placebo",{"label":20,"type":10,"description":11,"interventionNames":21},"SHR-1918 high dose",[13],{"label":23,"type":16,"description":11,"interventionNames":24},"SHR-1918 placebo high dose",[18],[26,30],{"type":27,"name":28,"description":28,"armGroupLabels":29,"otherNames":11},"DRUG","SHR-1918",[20,9],{"type":27,"name":31,"description":31,"armGroupLabels":32,"otherNames":11},"SHR-1918 placebo",[23,15],[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Sheng Qi","CONTACT","+86 0518 82342973","Sheng.qi@hengrui.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The Second Affiliated Hospital Zhejiang University School of Medicine","RECRUITING","Hangzhou","Zhejiang","310009","China","CN",{"type":49,"coordinates":50},"Point",[51,52],120.16142,30.29365,{"lat":52,"lon":51},[55],{"name":56,"role":57,"phone":11,"phoneExt":11,"email":11},"Jianan Wang","PRINCIPAL_INVESTIGATOR",{"type":59,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100610680","phase-3-a-trial-to-evaluate-the-efficacy-and-safety-of-shr-1918-in-patients-with-hyperlipidemia-100610680",false,"NCT07230730","A Trial to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia","Inclusion Criteria:\n\n1. the age must be at least 18 years old, and both men and women are eligible;\n2. the patient was receiving a stable dose of statins at the time of screening,, and the fasting LDL-C met: For individuals with extremely high risk of ASCVD, LDL-C≥1.4 mmol\u002FL; for those with very high risk of ASCVD, LDL-C≥1.8 mmol\u002FL; and for those with medium and high risk of ASCVD, ≥2.6 mol\u002FL;\n3. Fasting TG≥ 1.7 mmol\u002FL;\n4. Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person；\n\nExclusion Criteria:\n\n1. poorly controlled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg) at the time of screening or before randomization；\n2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or γ -glutamyl transferase (GGT) \\> 3× upper limit of normal (ULN), or total bilirubin \\> 2×ULN；\n3. Thyroid stimulating hormone (TSH) is lower than the lower limit of normal (LLN) or greater than 1.5×ULN；\n4. The estimated glomerular filtration rate (eGFR) is less than 30 mL\u002Fmin\u002F1.73m2；\n5. Previously suffering from diseases that have a significant impact on blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, etc","ALL","18 Years",{"count":70,"type":71},900,"ESTIMATED","INTERVENTIONAL",[74],"PHASE3","The study is being conducted to evaluate the efficacy, and safety of SHR-1918 in reducing serum low-density lipoprotein cholesterol (LDL-C) and total triglycerides (TG) in patients with hyperlipidemia compared with placebo, and also includes To evaluate the effectiveness of SHR-1918 in reducing other lipid indicators in patients with mixed hyperlipidemia and to assess the safety of SHR-1918 in patients with mixed hyperlipidemia.",[77],"Hyperlipidemia","2026-05-12",{"date":80,"type":81},"2026-05-14","ACTUAL",{"date":83,"type":81},"2026-01-13",{"date":85,"type":71},"2027-10",{"name":5,"class":6},1]