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NCT07216391 · ClinicalTrials.gov registry record · Phase 2
Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Not yet
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT07216391: Clinical Trial Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT07216391 is a Phase 2 study that has not yet begun recruiting, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07216391, a Phase 2 study, has not yet begun recruiting, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This is a 2-arm, multi-center, open label study to learn if ATG works the same or better than teplizumab in delaying or preventing Stage 3 Type 1 diabetes. Participants will be administered either 2 infusions of ATG or 14 infusions of teplizumab and will then be followed for at least 12-48 months after administration, depending on timepoint enrolled into the study. If the primary endpoint demonstrates a positive signal and as decided by TrialNet, there is potential for a study extention. This would extend follow-up visits for a possible study duration of about 9 years among the earliest enrollees of the initial study.
Primary Outcome
DPTRS is calculated as DPTRS = (1.569 x log-BMI) - (0.056 x age) + (0.813 x glucose sum from 30 to 120 min /100) - (0.848 x C-peptide sum from 30 to 120 min/10) + (0.476 x log-fasting C-peptide), where the units are years for age, kg/m2 for BMI, mg/dl for glucose, ng/ml for C-peptide
Interventions
- DRUG Teplizumab
- DRUG Antithymocyte Globulin (ATG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-07-30 |
| Est. Completion | 2030-05-30 |
| Phase | Phase 2 |
What is known before NCT07216391 opens enrollment
NCT07216391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Teplizumab is the first listed.
NCT07216391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07216391 about?
NCT07216391 is a clinical study titled "Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG". This is a 2-arm, multi-center, open label study to learn if ATG works the same or better than teplizumab in delaying or preventing Stage 3 Type 1 diabetes. Participants will be administered either 2 infusions of ATG or 14 infusions of teplizumab and will then be followed for at least 12-48 months af...
What is the current status of trial NCT07216391?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2026-07-30. Estimated completion is 2030-05-30.
What interventions are being tested in trial NCT07216391?
The interventions under investigation include: Teplizumab (DRUG), Antithymocyte Globulin (ATG) (DRUG).
Who is sponsoring clinical trial NCT07216391?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07216391's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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