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