NCT04291703

STOP-T1D Low-Dose (ATG)

Low Dose Antithymocyte Globulin (ATG) to Delay or Prevent Progression to Stage 3 T1D

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 6 Years – 34 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, placebo-controlled, double blind, 2:1 randomized control clinical trial testing low-dose ATG vs. placebo in subjects with a 2 year 50% risk of progression to stage 3 T1D.

Detailed description

This study has an enrollment period of 4 years and once the enrollment phase has concluded, an additional two years of follow-up visits will be conducted for all participants. Participants enrolled in the first year of the study can expect to complete follow-up visits for approximately four additional years if progression to stage 3 (Type 1 Diabetes Onset) does not occur. Participant follow-up visits after the treatment phase of the study includes general assessments (medical history, physical exam, medications and adverse events) and laboratory assessments to determine current health status and glucose tolerance.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Antithymocyte Globulin	Thymoglobulin
DRUG	Placebo (for ATG)	Normal Saline administered by IV infusion to mimic ATG

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-12-17
• Completion: 2024-12-17
• First posted: 2020-03-02
• Last updated: 2025-09-25

Locations

22 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study