ObservationalRecruitingNCT07360080
AL1GN: long-term outcomes of teplizumab in routine care
Sanofi's recruiting observational cohort following people who received teplizumab for stage 2 T1D as part of ordinary care, for up to 10 years. It measures time to stage 3 and real-world safety; it does not test a new drug.
Primary endpoints
- Time from teplizumab infusion start to onset of stage 3 T1D (up to 10 years)
Results so far
No results. Recruiting; estimated n=1,000 across about 85 sites in 19 countries; actual start 19 March 2026; primary completion estimated 29 October 2035. Last registry update 25 August 2026.
The full picture
AL1GN is a post-approval follow-up study, not a new efficacy trial. It exists because teplizumab is already being given in clinic, and we still need a decade of real-world time-to-stage-3 and safety data. It should not be read as new evidence that teplizumab works.