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Phase 2RecruitingNCT07216391

TrialNet platform: teplizumab vs low-dose ATG to delay stage-3 T1D

What this study tests

NIDDK TrialNet adaptive platform trial comparing teplizumab with low-dose anti-thymocyte globulin in stage-2 T1D to test whether ATG can match or beat the approved delay therapy.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2026-09-09.

Source dates appear in the references where available; this record has no dated citation metadata.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
People aged 4-34 with stage-2 T1D. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
Recruiting in the ClinicalTrials.gov update posted 9 September 2026, consistent with TrialNet’s ASCEND page. The earlier registry-versus-program discrepancy has resolved. Estimated enrollment is 60, with estimated primary completion 30 November 2029 and final completion 30 May 2030. No results are posted.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • Change in Diabetes Prevention Trial–Type 1 Risk Score (DPTRS) at six months. This risk score is a surrogate measure; it is not directly a count of prevented diagnoses.

The full picture

This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.

Sources

  1. [1]
    NCT07216391: TrialNet platform: teplizumab vs low-dose ATG to delay stage-3 T1D · Trial registry — Recruiting in the ClinicalTrials.gov update posted 9 September 2026, consistent with TrialNet’s ASCEND page. The earlier registry-versus-program discrepancy has resolved. Estimated enrollment is 60, with estimated primary completion 30 November 2029 and final completion 30 May 2030. No results are posted.
  2. [2]
    ATG and Teplizumab Comparative Prevention Study (ASCEND T1D) · Trial registry — TrialNet participant-facing page reports currently enrolling. Registry now agrees.