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NCT07088068 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Type 1 Diabetes Mellitus, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 723
- Enrollment target
- 20
- Study locations
NCT07088068: Recruiting Phase 3 study of Type 1 Diabetes Mellitus, sponsored by Sanofi.
NCT07088068 is a Phase 3 study of Type 1 Diabetes Mellitus that is actively recruiting participants, run by Sanofi. The registered enrollment target is 723 participants, above the 166-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (336% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07088068, a Phase 3 study of Type 1 Diabetes Mellitus, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 723 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Teplizumab
Study Locations (20)
Florida
- University of Florida College of Medicine- Site Number : 8400054 - Gainesville
- Encore Medical Research - Hollywood- Site Number : 8400061 - Hollywood
- University of South Florida- Site Number : 8400013 - Tampa
Georgia
- Atlanta Diabetes Associates- Site Number : 8400036 - Atlanta
- IACT Health - Columbus - Talbotton Road- Site Number : 8400003 - Columbus
- Institute of Endocrinology Diabetes, Health & Hormones- Site Number : 8400050 - Stockbridge
New York
- University at Buffalo - Jacobs School of Medicine- Site Number : 8400006 - Buffalo
- Endocrine Associates of West Village- Site Number : 8400064 - New York
- Columbia University Irving Medical Center- Site Number : 8400009 - New York
California
- Marvel Clinical Research- Site Number : 8400042 - Huntington Beach
- University of California San Francisco - Mission Bay- Site Number : 8400011 - San Francisco
Idaho
- St. Luke's Children's Hospital- Site Number : 8400014 - Boise
- Rocky Mountain Clinical Research - Idaho Falls- Site Number : 8400001 - Idaho Falls
Arizona
- Scottsdale Clinical Trials- Site Number : 8400044 - Scottsdale
Colorado
- Barbara Davis Center for Childhood Diabetes- Site Number : 8400031 - Aurora
Connecticut
- Yale University School of Medicine- Site Number : 8400005 - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 723 participants |
| Start Date | 2025-08-06 |
| Est. Completion | 2028-12-12 |
| Phase | Phase 3 |
What NCT07088068 shows while recruiting
NCT07088068 is an interventional study that assigns participants to a tested intervention. The registered 723 participants enrollment target is mid-sized for trials with a published cap, above the 166-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (336% higher).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07088068 names 20 study sites across 12 states, led by Florida, Georgia, New York.
Frequently Asked Questions
What is clinical trial NCT07088068 about?
NCT07088068 is a clinical study titled "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". 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 intravenou...
What is the current status of trial NCT07088068?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 723 participants. The study started on 2025-08-06. Estimated completion is 2028-12-12.
What conditions does trial NCT07088068 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT07088068?
The interventions under investigation include: Placebo (OTHER), Teplizumab (DRUG).
Who is sponsoring clinical trial NCT07088068?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07088068 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
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 NCT07088068's enrollment target sits among peer trials
723 5th of 112 higher than 108 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus 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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