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Teplizumab in Pediatric Stage 2 Type 1 Diabetes
NCT05757713 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to assess the safety and pharmacokinetics (PK) of teplizumab in participants with Stage 2 type 1 diabetes who are \<8 years of age.
Conditions Studied
Interventions
- BIOLOGICAL teplizumab
Study Locations (10)
California
- UCSF Medical Center Site Number : 107 — San Francisco
Colorado
- Barbara Davis Center for Diabetes Site Number : 102 — Aurora
Connecticut
- Yale University School of Medicine Site Number : 101 — New Haven
Georgia
- Centricity Research Site Number : 104 — Columbus
Indiana
- Indianapolis University Health Riley Hospital for Children Site Number : 110 — Indianapolis
New York
- UBMD Pediactrics Site Number : 105 — Buffalo
Pennsylvania
- Children's Hospital of Philadelphia Site Number : 108 — Philadelphia
South Dakota
- Sanford Diabetes and Thyroid Clinic Site Number : 106 — Sioux Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-07-25 |
| Est. Completion | 2026-08-27 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05757713
The ClinicalTrials.gov registry entry for NCT05757713 describes a study currently listed as active not recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 1 intervention — of which teplizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05757713 reports 10 study locations spanning 10 distinct geographic areas — top geographies include California, Colorado, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05757713 about?
NCT05757713 is a clinical study titled "Teplizumab in Pediatric Stage 2 Type 1 Diabetes". The purpose of this study is to assess the safety and pharmacokinetics (PK) of teplizumab in participants with Stage 2 type 1 diabetes who are \<8 years of age.
What is the current status of trial NCT05757713?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2023-07-25. Estimated completion is 2026-08-27.
What conditions does trial NCT05757713 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05757713?
The interventions under investigation include: teplizumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05757713?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05757713 being conducted?
This trial has 10 study locations across California, Colorado, Connecticut, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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