NCT07062588 Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
| NCT ID | NCT07062588 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Angitia Incorporated Limited |
| Condition | Osteogenesis Imperfecta (OI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-12-12 |
| Primary Completion | 2027-11 |
Trial Parameters
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Brief Summary
This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Treatment with bisphosphonates within the past 6 months * Treatment wi