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NCT05757713 · ClinicalTrials.gov registry record · Phase 4

Teplizumab in Pediatric Stage 2 Type 1 Diabetes

A Phase 4 study of Diabetes Mellitus, Type 1, sponsored by Sanofi.

Active
Registry status
Phase 4
Development phase
20
Enrollment target
10
Study locations

NCT05757713: Active Phase 4 study of Diabetes Mellitus, Type 1, sponsored by Sanofi.

NCT05757713 is a Phase 4 study of Diabetes Mellitus, Type 1 that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 20 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (98% lower). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05757713, a Phase 4 study of Diabetes Mellitus, Type 1, is active but no longer recruiting, sponsored by Sanofi.

ACTIVE NOT RECRUITING
Registry status
Phase 4
Development phase
20 participants
Enrollment target
10
Study locations

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.

Primary Outcome

Safety and tolerability endpoint

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

FieldValue
Enrollment Target 20 participants
Start Date 2023-07-25
Est. Completion 2026-08-27
Phase Phase 4
Sanofi

713 total trials

What the registry record for NCT05757713 still lists

NCT05757713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (98% lower).

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.

NCT05757713 lists 10 locations in 10 states (California, Colorado, Connecticut).

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.

What interventions are being tested in trial NCT05757713?

The interventions under investigation include: teplizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT05757713?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Diabetes Mellitus, Type 1

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05757713's enrollment target sits among peer trials

20 96th of 118 higher than 16 of 118 other Diabetes Mellitus, Type 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05757713, the US trial registry maintained by the National Library of Medicine. NCT05757713 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.