RecruitingPhase 1Phase 2NCT07061574

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


Sponsor

City of Hope Medical Center

Enrollment

120 participants

Start Date

Mar 30, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 9 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a combination of immune-calming drugs — a low dose of ATG (a medication that reduces immune attack) followed by either adalimumab or verapamil — can help preserve the remaining insulin-producing cells in young people newly diagnosed with type 1 diabetes. **You may be eligible if...** - You are between 9 and under 21 years old - You were diagnosed with type 1 diabetes within the last 6 months - You have at least one positive diabetes-related antibody in your blood - Your pancreas still produces some insulin (confirmed by a specific blood test) - You weigh more than 30 kg and have a BMI below the 95th percentile for your age - You are willing to follow intensive diabetes management during the study **You may NOT be eligible if...** - You were diagnosed more than 6 months ago - Your pancreas produces very little or no insulin - You are pregnant or planning to become pregnant 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.

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Interventions

DRUGAnti-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.

DRUGverapamil extended-release capsule

Daily oral (pill) administration at 60, 120, 240 or 360 mg based on weight and ECG findings.

DRUGAdalimumab

40 mg administered subcutaneously every other week beginning 6 weeks after the last dose of ATG until the 156-week visit.


Locations(11)

UCSF

San Francisco, California, United States

Barbara Davis Center for Diabetes University of Colorado Anschutz

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

University of Florida

Gainesville, Florida, United States

University of Miami

Miami, Florida, United States

Indiana University

Indianapolis, Indiana, United States

University of Minnesota

Minneapolis, Minnesota, United States

University of Buffalo

Buffalo, New York, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07061574


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