RecruitingPhase 2NCT06455319

Precision Administration of Anti-thymocyte Globulin With or Without Verapamil

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


Sponsor

University of Florida

Enrollment

60 participants

Start Date

Nov 12, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving a medication called anti-thymocyte globulin (a drug that dampens the immune system) with or without verapamil (a heart medication that may also protect insulin-producing cells) can preserve the body's remaining ability to make insulin in people recently diagnosed with type 1 diabetes. **You may be eligible if...** - You are between 6 and 35 years old - You were diagnosed with type 1 diabetes within the last 100 days - You have tested positive for at least one diabetes-related antibody - Your body is still producing some insulin (confirmed by a blood test) - You or your parent/guardian can provide consent **You may NOT be eligible if...** - You were diagnosed more than 100 days ago - Your body is no longer producing detectable insulin - You do not meet the antibody or lab criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAnti-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).

DRUGverapamil extended release capsule

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

DRUGPlacebo

I.V. Saline


Locations(2)

Barbara Davis Center for Diabetes

Aurora, Colorado, United States

University of Florida

Gainesville, Florida, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06455319


Related Trials