[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635804":3},{"organization":4,"armGroups":7,"interventions":42,"overallOfficials":26,"centralContacts":48,"locations":54,"responsibleParty":112,"collaborators":26,"id":114,"slug":26,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":115,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":26,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":57,"whyStopped":26,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},{"fullName":5,"class":6},"Angitia Biopharmaceuticals","INDUSTRY",[8,14,18,22,27,31,35,39],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Adult participants will receive AGA2115 Dose Regimen 1.",[13],"Drug: AGA2115",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","Adult participants will receive AGA2115 Dose Regimen 2.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3","Adult participants will receive AGA2115 Dose Regimen 3.",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"Cohort 4","NO_INTERVENTION","Adult participants will only receive AGA2115 Dose Regimen 2 in the second year.",null,{"label":28,"type":10,"description":29,"interventionNames":30},"Cohort 5","Adolescent participants will receive AGA2115 Dose Regimen 1.",[13],{"label":32,"type":10,"description":33,"interventionNames":34},"Cohort 6","Adolescent participants will receive AGA2115 Dose Regimen 2.",[13],{"label":36,"type":10,"description":37,"interventionNames":38},"Cohort 7","Adolescent participants will receive AGA2115 Dose Regimen 3.",[13],{"label":40,"type":24,"description":41,"interventionNames":26},"Cohort 8","Adolescent participants will only receive AGA2115 Dose Regimen 2 in the second year.",[43],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":26},"DRUG","AGA2115","Participants will receive AGA2115 administered by subcutaneous injection",[9,15,19,28,32,36],[49],{"name":50,"role":51,"phone":52,"phoneExt":26,"email":53},"Yolanda Liu","CONTACT","+86 13911537795","yolanda.liu@angitiabio.com",[55,72,85,99],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Chinese Academy of Medical Sciences, Peking Union Medical College Hospital","RECRUITING","Beijing","Beijing Municipality","100005","China",{"type":63,"coordinates":64},"Point",[65,66],116.39723,39.9075,{"lat":66,"lon":65},[69],{"name":70,"role":71,"phone":26,"phoneExt":26,"email":26},"Mei Li","PRINCIPAL_INVESTIGATOR",{"facility":73,"status":57,"city":74,"state":75,"zip":76,"country":61,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"The University of Hong Kong-Shenzhen Hospital","Shenzhen","Guangdong","518053",{"type":63,"coordinates":78},[79,80],114.0683,22.54554,{"lat":80,"lon":79},[83],{"name":84,"role":71,"phone":26,"phoneExt":26,"email":26},"Kai Tsun Michael To",{"facility":86,"status":87,"city":88,"state":89,"zip":90,"country":61,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Children's Hospital of Soochow University","NOT_YET_RECRUITING","Suzhou","Jiangsu","215025",{"type":63,"coordinates":92},[93,94],120.59538,31.30408,{"lat":94,"lon":93},[97],{"name":98,"role":71,"phone":26,"phoneExt":26,"email":26},"Ting Chen",{"facility":100,"status":87,"city":101,"state":102,"zip":103,"country":61,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Shanghai Sixth People's Hospital","Shanghai","Shanghai Municipality","200233",{"type":63,"coordinates":105},[106,107],121.45806,31.22222,{"lat":107,"lon":106},[110],{"name":111,"role":71,"phone":26,"phoneExt":26,"email":26},"Zhenlin Zhang",{"type":113,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100635804",false,"NCT07557446","A Dose REgimen-Finding Study of AGA2115 in Chinese Patients With Osteogenesis ImpeRfecta (EIR)","A Phase 2 Multi-center, Randomized, Open-Label, Dose Regimen-Finding Study of AGA2115 in Chinese Adults and Adolescents With Type I, III, or IV Osteogenesis Imperfecta","EIR","Inclusion Criteria:\n\n* Adults (18-75 years) or adolescents (12-17 years) with a confirmed diagnosis of Osteogenesis Imperfecta (OI) Type I, III, or IV with genetic confirmation of pathogenic variants in COL1A1 or COL1A2 genes\n* BMD T-score of ≤-1.0 at the lumbar spine, total hip, or femoral neck (adults) or BMD Z-score of ≤-1.0 at the lumbar spine, total hip, or femoral neck (adolescents)\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol\n\nExclusion Criteria:\n\n* Vitamin D deficiency\n* Concomitant uncontrolled diseases or conditions that could affect bone metabolism such as hypo-\u002Fhyperparathyroidism, hypo-\u002Fhyperthyroidism, abnormal thyroid function or thyroid disease, or other endocrine disorders.\n* Current hyper- or hypocalcemia.\n* History of rickets, osteomalacia, or other significant skeletal disorders (excluding OI) leading to long-bone deformities and\u002For increased risk of fractures.\n* Use of bisphosphonates within the past 6 months.\n* Use of teriparatide, abaloparatide, strontium ranelate, or hormone replacement therapy within the past 12 months.\n* Use of denosumab (or denosumab biosimilars) within the past 2 years.\n* Use of anti-sclerostin antibody medications (romosozumab, setrusumab, blosozumab) at any time.\n* History of myocardial infarction or stroke (or other cardiovascular associated event deemed significant) within the past 12 months.\n* Malignancy within the last 5 years.\n* Pregnant or breastfeeding women, or women planning to become pregnant during the study or within 4 months after the last dose of IP.","ALL","12 Years","75 Years",{"count":125,"type":126},48,"ESTIMATED","INTERVENTIONAL",[129],"PHASE2","This study is to evaluate the safety and efficacy of AGA2115 at three different dose regimens in Chinese adults and adolescents with Type I, III, or IV Osteogenesis imperfecta (OI).",[132],"Osteogenesis Imperfecta (OI)",[134,135,136],"Osteogenesis Imperfecta","dose regimen finding","Phase 2","2026-06-17",{"date":139,"type":140},"2026-06-22","ACTUAL",{"date":142,"type":126},"2026-06",{"date":144,"type":126},"2029-07",{"name":146,"class":6},"Angitia Biopharmaceuticals Guangzhou Limited",4]