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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
NCT07088068 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07088068
The ClinicalTrials.gov registry entry for NCT07088068 describes a study currently listed as recruiting. It is categorized as Phase 3, 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 723 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 Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT07088068 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Georgia, New York. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07088068?
The interventions under investigation include: Placebo (OTHER), Teplizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07088068?
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 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.
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