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Phase 3 randomized, double-blind study of teplizumab in newly diagnosed Stage 3 type 1 diabetes

jRCT2051250224Phase 3Recruiting

Sponsor
Sanofi
Start
Mar 2026
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
01

Overview

Phase 3, randomised, double-blind trial in diabetes mellitus type 1 (T1D) comparing Teplizumab with Placebo (2 arms). Primary endpoints: HbA1c change from baseline (US and non-EU countries), Total number of days without prandial insulin use (US and non-EU countries) and 3 more. Started Mar 2026; status: recruiting.

02

Drugs

teplizumab
03

Conditions

diabetes mellitus type 1 (T1D)

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