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RECRUITING
NCT06455319
PHASE2

Precision Administration of Anti-thymocyte Globulin With or Without Verapamil

Sponsor: University of Florida

View on ClinicalTrials.gov

Summary

T cell directed therapy, anti-thymocyte globulin (ATG), in low doses, has been shown to lower HbA1c and preserve endogenous insulin production (measured by C-peptide) in individuals with recently diagnosed type 1 diabetes (T1D). However, not all individuals who received ATG responded to the therapy (i.e., non-responders). Additionally, use of ATG alone does not address inherent beta cell stress. A calcium channel blocker, verapamil, has demonstrated C-peptide preservation in newly diagnosed T1D. Investigators will identify those mostly likely to respond to ATG using an ex vivo predictive biomarker of response to ATG. In addition, Investigators will use sequential therapies to increase efficacy (ATG followed by verapamil) and explore synergistic mechanisms. This will be assessing with in depth immunophenotyping and quantify biomarkers of beta cell stress, cell death, and abnormal prohormone processing. Finally, novel clinical trial endpoints will be assessed for their ability to predict treatment efficacy earlier than the standard endpoint at 1 year.

Official title: Precision Administration of Anti-thymocyte Globulin With or Without Verapamil in Adolescents and Young Adults With Type 1 Diabetes

Key Details

Gender

All

Age Range

6 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-11-12

Completion Date

2030-08

Last Updated

2025-11-26

Healthy Volunteers

No

Conditions

Interventions

DRUG

Anti-thymocyte globulin (ATG)

ATG (brand name Thymoglobulin) a polyclonal T cell antibody preparation. It will be given at low doses (0.5 mg/kg Day 1 then 2 mg/kg Day 2).

DRUG

verapamil extended release capsule

Open label administration at 120, 240 or 360 mg daily based on weight and ECG findings

DRUG

Placebo

I.V. Saline

Locations (2)

Barbara Davis Center for Diabetes

Aurora, Colorado, United States

University of Florida

Gainesville, Florida, United States