Clinical Trial

Setrusumab vs Placebo for Osteogenesis Imperfecta

Study acronym: Orbit
Active, Not Recruiting Phase 2/3
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Summary
The primary objectives of the study are to identify a setrusumab dosing strategy in participants with OI and to evaluate the effect of setrusumab vs placebo on reduction in fracture rate.
Protocol Amendment History 44 amendments
This ClinicalTrials.gov record has been amended 44 times since 2021-11-08; most recent amendment 2026-02-24.
Status change: Recruiting → Active, Not Recruiting 2024-05-01
Status change: Not Yet Recruiting → Recruiting 2022-01-08
Trial Details
NCT Number NCT05125809
Lead Sponsor Ultragenyx Pharmaceutical Inc
Collaborators: Mereo BioPharma
Conditions Osteogenesis Imperfecta
Enrollment 183 participants
Start Date 2022-02-21
Primary Completion 2025-10-20 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-02-25