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NCT06455319 · ClinicalTrials.gov registry record · Phase 2
Precision Administration of Anti-thymocyte Globulin With or Without Verapamil
A Phase 2 study of Type 1 Diabetes, sponsored by University of Florida.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT06455319 is a Phase 2 study of Type 1 Diabetes that is actively recruiting participants, run by University of Florida. The registered enrollment target is 60 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06455319, a Phase 2 study of Type 1 Diabetes, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Anti-thymocyte globulin (ATG)
- DRUG verapamil extended release capsule
Study Locations (2)
Colorado
- Barbara Davis Center for Diabetes - Aurora
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-11-12 |
| Est. Completion | 2030-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06455319
The ClinicalTrials.gov registry entry for NCT06455319 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (93% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06455319 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT06455319 about?
NCT06455319 is a clinical study titled "Precision Administration of Anti-thymocyte Globulin With or Without Verapamil". 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 ...
What is the current status of trial NCT06455319?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-11-12. Estimated completion is 2030-08.
What conditions does trial NCT06455319 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT06455319?
The interventions under investigation include: Placebo (DRUG), Anti-thymocyte globulin (ATG) (DRUG), verapamil extended release capsule (DRUG).
Who is sponsoring clinical trial NCT06455319?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06455319 being conducted?
This trial has 2 study locations across Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.