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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: Recruiting Phase 2 study of Type 1 Diabetes, sponsored by University of Florida.

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 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

mean difference between ATG and placebo values of the 2-hr mixed meal tolerance test (MMTT)-stimulated area under the curve (AUC) C-peptide at 12 months

Conditions Studied

Type 1 Diabetes

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

FieldValue
Enrollment Target 60 participants
Start Date 2025-11-12
Est. Completion 2030-08
Phase Phase 2
University of Florida

1,106 total trials

What NCT06455319 shows while recruiting

NCT06455319 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (92% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Type 1 Diabetes

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06455319's enrollment target sits among peer trials

60 73rd of 198 higher than 117 of 198 other Type 1 Diabetes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06455319

Source: ClinicalTrials.gov NCT06455319, the US trial registry maintained by the National Library of Medicine. NCT06455319 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.