IDUN
Research type
Research Study
Full title
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)
IRAS ID
1012871
Contact name
Ricardo Dent
Contact email
Sponsor organisation
Angitia Incorporated Limited
Eudract number
2025-522951-24
Clinicaltrials.gov Identifier
Research summary
This study tests an investigational medication called AGA2115. AGA2115 is an investigational medication because it has not been approved by any health authorities to treat any condition, and research is ongoing into how it works and how safe it is. AGA2115 is being tested to see if it can treat osteogenesis imperfecta (OI). OI is a rare condition passed down in families that makes bones weaker and more likely to break. AGA2115 may help build and strengthen bones, and reduce bone loss, leading to fewer bone breaks.
This study will try to find out:
• Whether AGA2115 is effective, i.e., if AGA2115 can increase bone mass and strength, and reduce the chance of bone breaks in patients with OI.
• How safe AGA2115 is, i.e., what side effects AGA2115 might cause and how serious they are.
• What the body does to AGA2115, i.e., how the body breaks down AGA2115, and how long AGA2115 stays in the body.
• How the immune system responds to AGA2115, i.e., if the body tries to make antibodies against AGA2115 (proteins that may cause side effects or reduce the effectiveness of AGA2115).REC name
East of England - Cambridge East Research Ethics Committee
REC reference
26/EE/0072
Date of REC Opinion
1 May 2026
REC opinion
Further Information Favourable Opinion