[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Angitia Biopharmaceuticals Guangzhou Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"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).",[27],"Osteogenesis Imperfecta (OI)",[29,30,31],"Osteogenesis Imperfecta","dose regimen finding","Phase 2","RECRUITING","2026-06-17",{"date":35,"type":36},"2026-06-22","ACTUAL",{"date":38,"type":21},"2026-06",{"date":40,"type":21},"2029-07",{"name":42,"class":43},"Angitia Biopharmaceuticals Guangzhou Limited","INDUSTRY",4,""]