NCT07062588

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

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Angitia Incorporated Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.

Detailed description

This Phase 2 dose-ranging study will evaluate the safety and efficacy of AGA2115 at a range of doses in adults with Type I, III, or IV osteogenesis imperfecta. The study will last 27 months with a 24-month treatment period and a 3-month follow-up period. During the first 12 months of the study, participants will be randomized 1:1:1:1 to receive either placebo or one of three dose levels of AGA2115 doses; treatment assignment will be double-blind. Months 12 to 24 will be open-label, and all participants will receive AGA2115. Participants will attend visits where safety and efficacy parameters will be evaluated.

Conditions

• Osteogenesis Imperfecta (OI)

Interventions

Type	Name	Description
DRUG	AGA2115	Subcutaneous injection
OTHER	Placebo	Subcutaneous injection

Timeline

• Start date: 2025-12-12
• Primary completion: 2027-11-01
• Completion: 2029-02-01
• First posted: 2025-07-14
• Last updated: 2026-01-13

Locations

26 sites across 8 countries: United States, Argentina, Australia, Canada, Denmark, France, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study