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).
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
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)
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
Vitamin D deficiency
Concomitant uncontrolled diseases or conditions that could affect bone metabolism such as hypo-/hyperparathyroidism, hypo-/hyperthyroidism, abnormal thyroid function or thyroid disease, or other endocrine disorders.
Current hyper- or hypocalcemia.
History of rickets, osteomalacia, or other significant skeletal disorders (excluding OI) leading to long-bone deformities and/or increased risk of fractures.
Parallel
AGA2115
DrugParticipants will receive AGA2115 administered by subcutaneous injection
8
Treatment groupsSee each treatment group below.
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Percent change from Baseline at Month 3, 6, 9 and 12 in Bone Mineral Density (BMD) at lumbar spine, total hip, femoral neck, one-third distal radius, and total body (minus head) for adults and adolescents.
Change from Baseline at Month 3, 6, 9, and 12 in BMD Z-score at lumbar spine, total hip, femoral neck, one-third distal radius, and total body (minus head) for adolescents.
Percent Change from Baseline at Week 1 and Month 1, 3, 6, 9, and 12 in bone turnover markers CTX-1 and P1NP
Percentage of participants with fractures between Baseline and Month 12
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