A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of AGA2115 in Adults With Type I, III, or IV Osteogenesis Imperfecta (OI)

What this Trial Is About

Researchers are evaluating the safety and effects of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta who have genetic variations in the COL1A1 or COL1A2 genes. This Phase 2 study compares different doses of AGA2115 with a placebo to better understand its impact on bone density and fracture rates. The trial is sponsored by Angitia Incorporated Limited and includes a randomized, double-blind design during the first year. Participants will be randomly assigned to one of four groups receiving either placebo or one of three dose levels of AGA2115 by subcutaneous injection during the first 12 months. After this double-blind period, all participants will enter a 12-month open-label phase where they will receive active AGA2115 treatment at specified doses depending on their initial group. The total treatment period lasts 24 months, followed by a 3-month follow-up. Throughout the study, participants will attend visits to assess safety and measure bone mineral density (BMD) at various sites, along with bone turnover markers and fracture incidence. The primary outcome measures the percent change in lumbar spine BMD after 12 months. Secondary outcomes include changes in BMD at other skeletal sites, bone markers over time, and fracture rates during the double-blind phase. Safety monitoring continues during follow-up, and the total participation time is approximately 27 months.

Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)