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NCT07061574 · ClinicalTrials.gov registry record · Phase 1
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
A Phase 1 study of Type 1 Diabetes and New Onset, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 11
- Study locations
NCT07061574: Recruiting Phase 1 study of Type 1 Diabetes and New Onset, sponsored by City of Hope Medical Center.
NCT07061574 is a Phase 1 study of Type 1 Diabetes and New Onset that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 120 participants, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (84% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07061574, a Phase 1 study of Type 1 Diabetes and New Onset, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 11
- Study locations
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.
Primary Outcome
The primary outcome is the C-peptide in response to a 2-hour MMTT at week 104. This is measured as the area under the stimulated C-peptide curve (AUC). AUC is computed using a trapezoidal rule, which is a weighted sum of the C-peptide values over 120 minutes.
Conditions Studied
Interventions
- DRUG Adalimumab
- DRUG Anti-thymocyte globulin (ATG)
- DRUG verapamil extended-release capsule
Study Locations (11)
Florida
- University of Florida - Gainesville
- University of Miami - Miami
California
- UCSF - San Francisco
Colorado
- Barbara Davis Center for Diabetes University of Colorado Anschutz - Aurora
Connecticut
- Yale University - New Haven
Indiana
- Indiana University - Indianapolis
Minnesota
- University of Minnesota - Minneapolis
New York
- University of Buffalo - Buffalo
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2026-03-30 |
| Est. Completion | 2031-04-15 |
| Phase | Phase 1 |
What NCT07061574 shows while recruiting
NCT07061574 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Type 1 Diabetes appearing as the primary indexed condition, and to 3 interventions - of which Adalimumab is the first listed.
NCT07061574 lists 11 locations in 10 states (Florida, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT07061574 about?
NCT07061574 is a clinical study titled "A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes". 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.
What is the current status of trial NCT07061574?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2026-03-30. Estimated completion is 2031-04-15.
What conditions does trial NCT07061574 study?
This clinical trial studies the following conditions: Type 1 Diabetes, New Onset.
What interventions are being tested in trial NCT07061574?
The interventions under investigation include: Adalimumab (DRUG), Anti-thymocyte globulin (ATG) (DRUG), verapamil extended-release capsule (DRUG).
Who is sponsoring clinical trial NCT07061574?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07061574 being conducted?
This trial has 11 study locations across California, Colorado, Connecticut, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07061574's enrollment target sits among peer trials
120 47th of 198 higher than 151 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.
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