Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes
← catalyst calendarNCT06791291 · readout in 564 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
10estimated
Sites
11
Country
Japan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-07-25 | actual | When the study began enrolling |
| Primary completion | 2028-03-06 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-03-06 | estimated | The whole study's end, after follow-up |
| First posted | 2025-01-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Type 1 Diabetes Mellitus
Intervention
- Drug: Teplizumab — also filed as SAR446681, TZIELD
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with Stage 3 Type 1 Diabetes based on American Diabetes Association criteria
measured From baseline up to Week 104
Change from baseline in area under the curve (AUC) of C-peptide
measured From baseline up to Week 104
Change from baseline in AUC of endogenous insulin
measured From baseline up to Week 104
Number of participants with TEAEs, SAEs, AEs leading to permanent study intervention- or study discontinuation; AEs of special interest; number of participants with clinically significant changes in vital signs, ECG, and/or safety laboratory test
measured Throughout the study, approximately 756 days
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