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ObservationalRecruitingNCT07360080

AL1GN: long-term outcomes of teplizumab in routine care

What this study tests

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.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2026-08-25.

Most recent recorded citation date: 2026-08-25. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
People who received at least one teplizumab infusion within 6 weeks before enrolment and who had stage 2 T1D at the first infusion. Prior teplizumab trial participants are excluded. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
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.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United States, Other regions. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • Time from teplizumab infusion start to onset of stage 3 T1D (up to 10 years)

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.

Sources

  1. [1]