This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.
Male or female adults (aged 18 to 75 years inclusive) with a clinical diagnosis of osteogenesis imperfecta Type I, III, or IV with documented genetic testing confirmation of genetic variations in the COL1A1 or COL1A2 genes
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
BMD T-score of ≤ -1.0 at the lumbar spine, total hip, or femoral neck
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 or osteomalacia or any skeletal condition (other than OI) leading to long-bone deformities and/or increased risk of fractures
Parallel
AGA2115
DrugSubcutaneous injection
Placebo
Other interventionSubcutaneous injection
Percent change from Baseline at Month 12 in lumbar spine BMD
Percent change from Baseline at Month 3 and 6 in lumbar spine, total hip, femoral neck, one-third distal radius, and total body (minus head) BMD
Percent change from Baseline at Month 12 in total hip, femoral neck, one-third distal radius, and total body (minus head) BMD
Percent change from Baseline at Week 1 and Month 1, 3, 6, 9, and 12 in P1NP and CTX-1
Percentage of participants with fractures during the double-blind treatment period
Assessment of TEAEs (collection and documentation of all adverse events occurring during the study)
Evaluation of AGA2115 observed serum concentration levels for the AGA2115 treatment groups
Number of participants who develop anti-AGA2115 antibodies
Click on the lead sponsor to view all of their trials.
