NCT07061574

A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 9 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

This multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \<21 with recent-onset stage 3 T1D.

Detailed description

The primary objective of this study is to assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons with T1D. The secondary objectives are to assess metabolic and safety endpoints at 2 years and at timepoints between baseline and two years.

Conditions

• Type 1 Diabetes
• New Onset

Interventions

Type	Name	Description
DRUG	Anti-thymocyte globulin (ATG)	ATG (brand name Thymoglobulin) a polyclonal T cell antibody preparation. The first dose (0.5 mg/kg) will be infused on day 0, during a period of 6 hours. The second dose (2 mg/kg) will be given on day 1, over a period of 4 to 6 hours.
DRUG	verapamil extended-release capsule	Daily oral (pill) administration at 60, 120, 240 or 360 mg based on weight and ECG findings.
DRUG	Adalimumab	40 mg administered subcutaneously every other week beginning 6 weeks after the last dose of ATG until the 156-week visit.

Timeline

• Start date: 2026-03-30
• Primary completion: 2030-04-15
• Completion: 2031-04-15
• First posted: 2025-07-11
• Last updated: 2026-03-16

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study