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teplizumab

Phase 3

Type 1 Diabetes Mellitus | Monoclonal antibody | Metabolic |Sanofi|Last Updated: Jul 9, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindNO_TREATMENT_CONTROLLEDDMC
Total Trials3
Total Enrollment1,061
FDA Designations
No designations recorded
Clinical trial landscape

teplizumab · 3 trials · 1 indication

Phase 3 2Phase 2 1
NCT03875729Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of TeplizumabType 1 Diabetes Mellitus
COMPLETED328 Analytics
NCT07088068A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 DiabetesType 1 Diabetes Mellitus
RECRUITING723 Analytics
PHASE3COMPLETED
Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
Type 1 Diabetes Mellitus
NCT03875729328
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PHASE3RECRUITING
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
Type 1 Diabetes Mellitus
NCT07088068723
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Study Endpoints
Primary Endpoints
For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline
From Baseline to Week 52
For US and non-EU countries: Total number of days without prandial insulin use
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
From baseline to Week 52
For EU countries: HbA1c change from baseline
From baseline to Week 52
For EU countries: Total number of days without prandial insulin use
From baseline to Week 52
Number of participants with Stage 3 Type 1 Diabetes based on American Diabetes Association criteria
From baseline up to Week 104
Change from baseline in area under the curve (AUC) of C-peptide
From baseline up to Week 104
Change from baseline in AUC of endogenous insulin
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
Throughout the study, approximately 756 days

TEAE: treatment-emerged adverse event; SAE: serious adverse event; AE: adverse event

Secondary Endpoints
Change from baseline in mean 2 hours MMTT stimulated C-peptide concentration, calculated from AUC
From baseline to Week 52
Participants remaining C-peptide positive (2 hours MMTT stimulated peak C-peptide concentration ≥0.2 nmol/L)
At Week 52
Incidence of participants with HbA1c ≤6.5% and requiring ≤0.25 IU/kg/day of insulin
At Week 52
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Study Design & Arms
Treatment Arms
ArmTypeDescription
TeplizumabEXPERIMENTALParticipants will receive teplizumab in increasing doses by intravenous administration
PlaceboPLACEBO_COMPARATORParticipants will receive volume matching placebo doses to the Teplizumab arm by intravenous administration
ControlNO_INTERVENTIONParticipants will receive no treatment in the control group
Interventions
NameTypeDescription
teplizumabBIOLOGICALTreatment
PlaceboBIOLOGICALControl
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Eligibility Criteria
Age Range1 Year to 25 Years
SexALL

Inclusion Criteria: * Participants are eligible to be included in the study only if all of the following criteria apply: * Participant must be 1 to 25 years of age inclusive, at the time of signing the informed consent. * Participants diagnosed with T1D Stage 3 according to American Diabetes Associ...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaChinaCzechiaFranceGermanyIsraelItalyJapanNetherlandsPolandSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJul 9, 2026NCT07088068lastUpdatePostDate: changed
LOWJul 9, 2026NCT07088068lastUpdatePostDate: changed
LOWJul 2, 2026NCT06791291lastUpdatePostDate: changed
LOWJul 2, 2026NCT06791291lastUpdatePostDate: changed
LOWJul 2, 2026NCT06791291lastUpdatePostDate: changed
LOWJul 2, 2026NCT06791291lastUpdatePostDate: changed
LOWJun 8, 2026NCT07088068lastUpdatePostDate: changed
LOWJun 8, 2026NCT07088068lastUpdatePostDate: changed
LOWJun 8, 2026NCT07088068lastUpdatePostDate: changed
LOWMay 26, 2026NCT07088068primaryCompletionDate: changed
LOWMay 26, 2026NCT06791291primaryCompletionDate: changed
LOWMay 24, 2026NCT07088068studyFirstPostDate: changed
LOWMay 24, 2026NCT06791291studyFirstPostDate: changed