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

NCT07061574 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Jaeb Center for Health Research

    collaborator OTHER

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Alberto Pugliese, MD · City of Hope Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-10
Primary Completion
2030-04-15
Completion
2031-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07061574 on ClinicalTrials.gov