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16 September 2026 editorial review · Trial

Ladarixin in recent-onset T1D: stopped for futility: review notes

These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.

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Primary-agent trial review — 16 September 2026

Assessment: New missed negative trial: terminated for futility; August 31 posted primary analysis: 140 vs registry header 289. Adjusted log-scale estimate/P value and inconsistent unit labels explained; no conversion to insulin production percentage.

Registry: NCT04628481; TERMINATED; updated 2026-08-31; enrollment 289 (ACTUAL); results posted.

Endpoint comparison: Change From Baseline in 2-hour Area Under the Concentration-time Curve (AUC) of C-peptide Response to the Mixed Model Tolerance Test (MMTT) (Baseline and at Month 6).

Sources for this record: A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function (NCT04628481) (registry).

Limits: Source access and review depth vary. Registry fields establish the registered study, not clinical benefit, product approval or current local access. Cited-source reachability alone was not treated as verification of its claims.

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