[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633001":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":53,"responsibleParty":257,"collaborators":259,"id":263,"slug":31,"hasResults":264,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":264,"sex":270,"minAge":271,"maxAge":272,"enrollmentInfo":273,"targetDuration":31,"studyType":276,"phases":277,"briefSummary":279,"conditions":280,"keywords":283,"overallStatus":286,"whyStopped":31,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":296},{"fullName":5,"class":6},"Beijing Inno Medicine Co., Ltd.","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose 1 YN001\u002FPlacebo 40mg","EXPERIMENTAL","Dose 1 YN001\u002FPlacobo 40mg will be administrated intravenously weekly",[13],"Drug: YN001\u002FPlacebo 40mg",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose 2 YN001\u002FPlacebo 20mg","Dose 2 YN001\u002FPlacebo 20mg will be administrated intravenously weekly",[18],"Drug: YN001\u002FPlacebo 20mg",{"label":20,"type":21,"description":22,"interventionNames":23},"Dose 3 YN001\u002FPlacebo 0mg","PLACEBO_COMPARATOR","Dose 3 YN001\u002FPlacebo 0mg will be administrated intravenously weekly",[24],"Drug: YN001\u002FPlacebo 0mg",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","YN001\u002FPlacebo 40mg","Dose 1 YN001\u002FPlacebo 40mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"YN001\u002FPlacebo 20mg","YN001\u002FPlacebo 20mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"YN001\u002FPlacebo 0mg","YN001\u002FPlacebo 0mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.",[20],[41],{"name":42,"affiliation":5,"role":43},"Ying Chen, PhD","STUDY_DIRECTOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},"Jingmei Zhang, Master","CONTACT","0086 010 82599080","zhangjingmei@innovmedicine.com",{"name":51,"role":47,"phone":48,"phoneExt":31,"email":52},"Kaiqi Zong, Master","zongkaiqi@innovmedicine.com",[54,77,93,107,125,143,159,175,191,207,213,229,245],{"facility":55,"status":31,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Anhui Provincial Hospital","Hefei","Anhui","230001","China","CN",{"type":62,"coordinates":63},"Point",[64,65],117.28083,31.86389,{"lat":65,"lon":64},[68,72,74],{"name":69,"role":47,"phone":70,"phoneExt":31,"email":71},"Kangyu Chen, MD","0086 18056005099","ustccky@126.com",{"name":69,"role":73,"phone":31,"phoneExt":31,"email":31},"PRINCIPAL_INVESTIGATOR",{"name":75,"role":76,"phone":31,"phoneExt":31,"email":31},"Chao Gao, MD","SUB_INVESTIGATOR",{"facility":78,"status":31,"city":79,"state":80,"zip":81,"country":59,"countryCode":60,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Anzhen Hospital","Beijing","Beijing Municipality","100029",{"type":62,"coordinates":83},[84,85],116.39723,39.9075,{"lat":85,"lon":84},[88,92],{"name":89,"role":47,"phone":90,"phoneExt":31,"email":91},"Yuyang Liu, MD","0086 010-64456488","liuyy803803@163.com",{"name":89,"role":73,"phone":31,"phoneExt":31,"email":31},{"facility":94,"status":31,"city":79,"state":80,"zip":95,"country":59,"countryCode":60,"cosmosGeoPoint":96,"geoPoint":98,"contacts":99},"Beijing Jishuitan Hospital","100035",{"type":62,"coordinates":97},[84,85],{"lat":85,"lon":84},[100,104,105],{"name":101,"role":47,"phone":102,"phoneExt":31,"email":103},"Qingwei Ji, MD","0086 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University","Harbin","Heilongjiang","150001",{"type":62,"coordinates":131},[132,133],126.65,45.75,{"lat":133,"lon":132},[136,140,141],{"name":137,"role":47,"phone":138,"phoneExt":31,"email":139},"Lu Fu, MD","0086 137 9668 4968","fuluyidayi@163.com",{"name":137,"role":73,"phone":31,"phoneExt":31,"email":31},{"name":142,"role":73,"phone":31,"phoneExt":31,"email":31},"Yongtai Gong, MD",{"facility":144,"status":31,"city":145,"state":146,"zip":147,"country":59,"countryCode":60,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Zhongnan Hospital of Wuhan University","Wuhan","Hubei","430071",{"type":62,"coordinates":149},[150,151],114.26667,30.58333,{"lat":151,"lon":150},[154,158],{"name":155,"role":47,"phone":156,"phoneExt":31,"email":157},"Zhibing Lu, MD","0086 15997405817","luzhibing222@163.com",{"name":155,"role":73,"phone":31,"phoneExt":31,"email":31},{"facility":160,"status":31,"city":161,"state":162,"zip":163,"country":59,"countryCode":60,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"The First Hospital of Jilin University","Changchun","Jilin","130033",{"type":62,"coordinates":165},[166,167],125.32278,43.88,{"lat":167,"lon":166},[170,174],{"name":171,"role":47,"phone":172,"phoneExt":31,"email":173},"Qian Tong, MD","0086 13074337289","tongqian187@aliyun.com",{"name":171,"role":73,"phone":31,"phoneExt":31,"email":31},{"facility":176,"status":31,"city":177,"state":178,"zip":179,"country":59,"countryCode":60,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"The People's Hospital of Liaoning Province","Shenyang","Liaoning","110015",{"type":62,"coordinates":181},[182,183],123.43278,41.79222,{"lat":183,"lon":182},[186,190],{"name":187,"role":47,"phone":188,"phoneExt":31,"email":189},"Ying Liu, MD","0086 13840065379","liuyingwangli@126.com",{"name":187,"role":73,"phone":31,"phoneExt":31,"email":31},{"facility":192,"status":31,"city":193,"state":194,"zip":195,"country":59,"countryCode":60,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"Renji Hospital Shanghai Jiaotong University school of medicine","Shanghai","Shanghai Municipality","200001",{"type":62,"coordinates":197},[198,199],121.45806,31.22222,{"lat":199,"lon":198},[202,206],{"name":203,"role":47,"phone":204,"phoneExt":31,"email":205},"Jun Bu, MD","0086 13601958108","pujun310@hotmail.com",{"name":203,"role":73,"phone":31,"phoneExt":31,"email":31},{"facility":208,"status":31,"city":193,"state":194,"zip":209,"country":59,"countryCode":60,"cosmosGeoPoint":210,"geoPoint":212,"contacts":31},"Fudan University-Zhongshan Hospital","200032",{"type":62,"coordinates":211},[198,199],{"lat":199,"lon":198},{"facility":214,"status":31,"city":215,"state":216,"zip":217,"country":59,"countryCode":60,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"West China Hospital of Sichuan University","Chengdu","Sichuan","610041",{"type":62,"coordinates":219},[220,221],104.06667,30.66667,{"lat":221,"lon":220},[224,228],{"name":225,"role":47,"phone":226,"phoneExt":31,"email":227},"Yong He, MD","0086 18980602038","zznnyeah@163.com",{"name":225,"role":73,"phone":31,"phoneExt":31,"email":31},{"facility":230,"status":31,"city":231,"state":232,"zip":233,"country":59,"countryCode":60,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Tianjin People's Hospital","Tianjin","Tianjin Municipality","300121",{"type":62,"coordinates":235},[236,237],117.17667,39.14222,{"lat":237,"lon":236},[240,244],{"name":241,"role":47,"phone":242,"phoneExt":31,"email":243},"Zhuhua Yao, MD","0086 13902199877","tjyzhpci@163.com",{"name":241,"role":73,"phone":31,"phoneExt":31,"email":31},{"facility":246,"status":31,"city":231,"state":232,"zip":247,"country":59,"countryCode":60,"cosmosGeoPoint":248,"geoPoint":250,"contacts":251},"The Second Hospital of Tianjin Medical University","300211",{"type":62,"coordinates":249},[236,237],{"lat":237,"lon":236},[252,256],{"name":253,"role":47,"phone":254,"phoneExt":31,"email":255},"Tong Liu, MD","0086 13902183163","liutongdoc@126.com",{"name":253,"role":73,"phone":31,"phoneExt":31,"email":31},{"type":258,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[260],{"name":261,"class":262},"The TIMI Study Group","OTHER","100633001",false,"NCT07521007","A Phase 2b Clinical Trial of YN001 in Adults With Coronary Atherosclerosis","A Randomized, Multicenter, Double-Blind, Parallel, Placebo-controlled Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of YN001 in Adults With Coronary Atherosclerosis","PURIFY-TIMI 81","Inclusion Criteria:\n\n1. Fully understands the purposes, features, and methods of the study and the possible adverse reactions, and is voluntarily willing to participate in the study, and signs the informed consent form (ICF) before performing any study-specific assessment.\n2. Male or female participants between 18 and 80 years (inclusive, at the time of signing the ICF).\n3. Participants must satisfy either of the following criteria:\n\n1\\) Have clinically evident atherosclerotic CV disease (ASCVD) 2) Meet at least two of the following criteria at screening\u002Fbaseline, as evidenced by:\n\n1. A history of Type 2 diabetes requiring treatment with medication,\n2. Aged \\> 55 years (women) or \\> 50 years (men),\n3. 2 or more of the following atherosclerosis risk factors:\n\n   * Current cigarette smoker\n   * Hypertension\n   * Estimated glomerular filtration rate (eGFR) 45 to 60 ml\u002Fmin\u002F1.73m2\n\n     4\\. Known coronary atherosclerosis as evidenced through coronary angiography or CCTA. The following criteria must be met on the core lab CCTA interpretation for the patient to be enrolled: at least one epicardial coronary artery with a lumen stenosis of 25% to 69%, total coronary NCPV is at least 75 mm3, Detectable low-attenuation composition in one or more individual plaques.\n\n     5\\. Female participants must be non-pregnant and non-lactating\n\n     6\\. Willing and able to comply with the requirements of protocol to the best of the participant's and investigator's knowledge.\n\nExclusion Criteria:\n\n1. Prior treatment with other investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to randomization.\n2. Previously received YN001.\n3. Any type of vaccination within 4 weeks prior to randomization, or any planned vaccination during the study treatment period\n4. Contraindication for CCTA\n5. 3 major epicardial coronary arteries with ≥ 70% or left main ≥50% stenosis.\n6. Acute MI that occurred within 4 weeks prior to randomization.\n7. PCI performed within 2 weeks prior to randomization or PCI is required or planned during study treatment based on clinical indication for revascularization.\n8. Clinically evident stroke or transient ischemic attack (TIA) within 6 months prior to randomization.\n9. Relapse and highly symptomatic arrhythmia uncontrolled by drugs within the past 3 months.\n10. Prior coronary artery bypass graft (CABG), aortic root surgery with coronary reimplantation, left ventricular assist device (LVAD) placement, surgical aortic valve replacement (SAVR), transcatheter aortic valve replacement (TAVR), or heart transplantation, or a plan to undergo these procedures (CABG, aortic root surgery with coronary reimplantation, LVAD placement, SAVR, TAVR, or heart transplantation) during the study.\n11. New York Heart Association class III or IV or last known left ventricular ejection fraction (LVEF) was \\\u003C40%.\n12. Carotid endarterectomy or stenting, peripheral arterial revascularization, or abdominal aortic aneurysm repair within 4 weeks prior to randomization.\n13. History of myopathy or myositis, or susceptibility to myopathy\u002Frhabdomyolysis (e.g., family history of hereditary myopathy, etc.).\n14. History of severe myalgia attributed to statin therapy or other significant concern about statin side effects.\n15. Known gastrointestinal ulcers, inflammatory bowel disease, or gastrointestinal\u002Frectal bleeding within 6 months prior to randomization.\n16. Evidence of unresolved major diseases 2 weeks prior to randomization or planned major surgery during the study that, in the investigator's judgement, may interfere with the investigational product administration or trial assessments.\n17. Presenting with history of malignancy (except in participants who have been disease-free \\>5 years; or whose only malignancy has been basal or squamous cell skin carcinoma).\n18. Presence of any type of autoimmune disease.\n19. Allergy to multiple foods or drugs or known sensitivity to any components to be administered during dosing.\n20. Life expectancy is less than 1 year.\n21. Systolic blood pressure of ≥ 160 mmHg at final screening despite antihypertensive therapy.\n22. Triglycerides ≥ 400 mg\u002FdL (4.5 mmol\u002FL) at final screening.\n23. LDL-C \\> 100 mg\u002FdL (2.6 mmol\u002FL) at final screening.\n24. Active liver disease or hepatic dysfunction defined by any of alanine aminotransaminase (ALT), aspartate aminotransferase (AST), \\> 3 times upper limit of normal (ULN), or total bilirubin \\> 2 times ULN at final screening.\n25. Presence of renal dysfunction, defined by eGFR \\\u003C 45 ml\u002Fmin\u002F1.73m2.\n26. Untreated or inadequately treated hypothyroidism.\n27. Poorly controlled Type 2 diabetes mellitus.\n28. A positive hepatitis B surface antigen (HBsAg), or positive antibody against hepatitis C virus (anti-HCV) or human immunodeficiency virus (anti-HIV), or positive treponema pallidum antibody (TP-Ab).\n29. Presence of any other diseases or conditions (apart from those outlined above) that, in the opinion of the investigator, would make it unsuitable for the participant to participate in this study.","ALL","18 Years","80 Years",{"count":274,"type":275},456,"ESTIMATED","INTERVENTIONAL",[278],"PHASE2","This study is designed to evaluate the efficacy and safety of intravenously administered YN001 in patients diagnosed with coronary atherosclerosis, who are receiving background therapy for cardiovascular (CV) risk factors management.",[281,282],"Atherosclerosis","Coronary Artery Disease",[284,285],"Plaque regression","Plaque stabilization","NOT_YET_RECRUITING","2026-04-02",{"date":289,"type":290},"2026-04-09","ACTUAL",{"date":292,"type":275},"2026-04-30",{"date":294,"type":275},"2029-03-31",{"name":5,"class":6},13]