NCT07216391

Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG

Adaptive Platform Trial to Delay Progression From Stage 2 to Stage 3 Type 1 Diabetes: Comparing Teplizumab With Low-dose Anti-Thymocyte Globulin (ATG) Protocol TN-40A

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 4 Years – 34 Years
• Healthy volunteers: Not accepted

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 be followed for 12 months after administration.

Detailed description

This protocol will enroll 60 participants with Stage 2 diabetes. Oral glucose tolerance testing will be done at the screening, baseline visit (V0) and at 3, 6 and 12 months after study drug administration. Participants will continue follow-up visits until 12 months from the baseline visit.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Antithymocyte Globulin (ATG)	Thymoglobulin
DRUG	Teplizumab	Intravenous infusions of teplizumab given for 14 consecutive days. Each infusion takes about 30 minutes and is followed by an observation period of at least 30 minutes.

Timeline

• Start date: 2026-04-15
• Primary completion: 2029-11-30
• Completion: 2030-05-30
• First posted: 2025-10-14
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study