Clinical Trial

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

Study acronym: βETA PRESERVE
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase 3, 2-arm study for treatment. The purpose of this study is to measure change in glycemic control and prandial insulin independency over 52 weeks with teplizumab compared with placebo, both administered by intravenous (IV) infusion, in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) aged 1 to 25 years, on standard insulin therapy.
Protocol Amendment History 4 changes
notable Trial sites expanded: 153 -> 159 locations 2026-06-09
notable Trial sites expanded: 141 -> 153 locations 2026-05-23
notable Trial sites expanded: 137 -> 141 locations 2026-04-24
notable Trial sites expanded: 124 -> 137 locations 2026-04-15
Trial Details
NCT Number NCT07088068
Lead Sponsor Sanofi
Conditions Type 1 Diabetes Mellitus
Enrollment 723 participants
Start Date 2025-08-06
Primary Completion 2028-06-06 (estimated)
Study Completion 2028-12-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-10