[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635804":3},{"organization":4,"armGroups":7,"interventions":42,"overallOfficials":26,"centralContacts":48,"locations":54,"responsibleParty":113,"collaborators":26,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":117,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":26,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":57,"whyStopped":26,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},{"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",[55,73,86,100],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Chinese Academy of Medical Sciences, Peking Union Medical College Hospital","RECRUITING","Beijing","Beijing Municipality","100005","China","CN",{"type":64,"coordinates":65},"Point",[66,67],116.39723,39.9075,{"lat":67,"lon":66},[70],{"name":71,"role":72,"phone":26,"phoneExt":26,"email":26},"Mei Li","PRINCIPAL_INVESTIGATOR",{"facility":74,"status":57,"city":75,"state":76,"zip":77,"country":61,"countryCode":62,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"The University of Hong Kong-Shenzhen Hospital","Shenzhen","Guangdong","518053",{"type":64,"coordinates":79},[80,81],114.0683,22.54554,{"lat":81,"lon":80},[84],{"name":85,"role":72,"phone":26,"phoneExt":26,"email":26},"Kai Tsun Michael To",{"facility":87,"status":88,"city":89,"state":90,"zip":91,"country":61,"countryCode":62,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Children's Hospital of Soochow University","NOT_YET_RECRUITING","Suzhou","Jiangsu","215025",{"type":64,"coordinates":93},[94,95],120.59538,31.30408,{"lat":95,"lon":94},[98],{"name":99,"role":72,"phone":26,"phoneExt":26,"email":26},"Ting Chen",{"facility":101,"status":88,"city":102,"state":103,"zip":104,"country":61,"countryCode":62,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Shanghai Sixth People's Hospital","Shanghai","Shanghai Municipality","200233",{"type":64,"coordinates":106},[107,108],121.45806,31.22222,{"lat":108,"lon":107},[111],{"name":112,"role":72,"phone":26,"phoneExt":26,"email":26},"Zhenlin Zhang",{"type":114,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100635804","phase-2-a-dose-regimen-finding-study-of-aga2115-in-chinese-patients-with-osteogenesis-imperfecta-eir-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":127,"type":128},48,"ESTIMATED","INTERVENTIONAL",[131],"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).",[134],"Osteogenesis Imperfecta (OI)",[136,137,138],"Osteogenesis Imperfecta","dose regimen finding","Phase 2","2026-06-17",{"date":141,"type":142},"2026-06-22","ACTUAL",{"date":144,"type":128},"2026-06",{"date":146,"type":128},"2029-07",{"name":148,"class":6},"Angitia Biopharmaceuticals Guangzhou Limited",4]