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NCT04628481 · ClinicalTrials.gov registry record · Phase 2
A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function
A Phase 2 study, sponsored by Dompé Farmaceutici S.p.A.
- Terminated
- Registry status
- Phase 2
- Development phase
- 141
- Enrollment target
NCT04628481: Clinical Trial Phase 2 study, sponsored by Dompé Farmaceutici S.p.A.
NCT04628481 is a Phase 2 study that was terminated before completion, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 141 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04628481, a Phase 2 study, was terminated before completion, sponsored by Dompé Farmaceutici S.p.A.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 141 participants
- Enrollment target
Study Summary
Objectives The objective of this clinical trial is to assess whether ladarixin treatment has an effect to preserve β-cell function and delay the progression of T1D in adolescent and adult patients. The safety of ladarixin in the specific clinical setting will be also evaluated.
Primary Outcome
Change from baseline in the 2-hour C-peptide Area Under the Curve (AUC) following a Mixed-Meal Tolerance Test (MMTT) at Month 6. The analysis used an adjusted ANCOVA model with the change from baseline in log(AUC + 1) as the dependent variable. Qualitative independent variables included treatment group, age group, sex, and BMI group, with the baseline value as a quantitative covariate. Missing data at Month 6 were handled via multiple imputation using a retrieved dropout approach. Missing values
Interventions
- DRUG Placebo
- DRUG Ladarixin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2021-01-12 |
| Est. Completion | 2025-10-21 |
| Phase | Phase 2 |
Why NCT04628481 stopped before completion
NCT04628481 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04628481 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04628481 about?
NCT04628481 is a clinical study titled "A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function". Objectives The objective of this clinical trial is to assess whether ladarixin treatment has an effect to preserve β-cell function and delay the progression of T1D in adolescent and adult patients. The safety of ladarixin in the specific clinical setting will be also evaluated.
What is the current status of trial NCT04628481?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 141 participants. The study started on 2021-01-12. Estimated completion is 2025-10-21.
What interventions are being tested in trial NCT04628481?
The interventions under investigation include: Placebo (DRUG), Ladarixin (DRUG).
Who is sponsoring clinical trial NCT04628481?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04628481's enrollment target sits among peer trials
141 510th of 2000 higher than 1,489 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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