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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07216391
The ClinicalTrials.gov registry entry for NCT07216391 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Teplizumab is the first listed.
NCT07216391 reports 0 study locations.
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.
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