Precision Administration of Anti-thymocyte Globulin With or Without Verapamil

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Florida
Study ID
NCT06455319
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Anti-thymocyte globulin (ATG) — DRUG
    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).
  • verapamil extended release capsule — DRUG
    Open label administration at 120, 240 or 360 mg daily based on weight and ECG findings
  • Placebo — DRUG
    I.V. Saline

Study Details

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.

Key Dates

Start date
Nov 12, 2025
Status verified
Nov 2025
Primary completion
Nov 30, 2028
Completion
Aug 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Anti-thymocyte globulin (ATG) intravenous infusion
    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).
  • Placebo Comparator: Placebo-ATG
    Saline placebo
  • Experimental: verapamil extended release capsule
    Open label administration at 120, 240 or 360 mg daily based on weight and ECG findings

Primary Outcome Measure

AUC C-peptide between ATG and placebo values [ Time Frame: 12 Months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Barbara Davis Center for DiabetesAuroraColorado80045
Kimber Simmons, MD
[email protected]
303-724-1055
University of FloridaGainesvilleFlorida32610
Jennifer L Hosford, MPH
[email protected]
352-294-5760
Laura M Jacobsen, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Barbara Davis Center for Diabetes· Aurora, COUniversity of Florida· Gainesville, FL

Related Studies