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 | Biotech Hunter

Enrollment

120

Participants

Timeline

Start Date

October 15, 2025

Primary Completion Date

April 15, 2030

Study Completion Date

April 15, 2031

Conditions

Type 1 DiabetesNew Onset

Interventions

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.

Trial Locations (2)

32610

University of Florida, Gainesville

55455

University of Minnesota, Minneapolis