A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes
← catalyst calendarNCT07088068 · readout in 657 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
723estimated
Sites
162
Countries
Argentina, Australia, Belgium +14
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 | 2025-08-06 | actual | When the study began enrolling |
| Primary completion | 2028-06-06 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-12-12 | estimated | The whole study's end, after follow-up |
| First posted | 2025-07-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-10 | 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
Interventions
- Drug: Teplizumab — also filed as SAR446681, TZIELD
- Other: Placebo
Primary outcomes
what the primary-completion date above is the date OFFor United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline
measured From Baseline to Week 52
For US and non-EU countries: Total number of days without prandial insulin use
measured From baseline to Week 52
For EU countries: Change from baseline in mean 2 hours mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from Area Under the Curve (AUC) in participants 5 years and older
measured From baseline to Week 52
For EU countries: HbA1c change from baseline
measured From baseline to Week 52
For EU countries: Total number of days without prandial insulin use
measured From baseline to Week 52
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