Ladarixin in recent-onset T1D: stopped for futility
What this study tests
A phase 2 randomized trial of oral ladarixin in recently diagnosed T1D was stopped for futility. Results posted on 31 August 2026 do not show a C-peptide benefit over placebo.
Editorial review: . What was checked and what remains uncertain.
Registry checked: 2026-09-16. Registry’s own update: 2026-08-31.
Source dates appear in the references where available; this record has no dated citation metadata.
Trial status, labels and access can change between reviews.
Evidence at a glance
- Who can enter the study?
- Participants aged 14–45, starting study drug within 180 days of first insulin, with an islet autoantibody, fasting C-peptide below 0.205 nmol/L and stimulated C-peptide above 0.2 nmol/L. Enrollment is closed. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- The posted primary analysis includes 140 participants (94 ladarixin, 46 placebo), whereas the registry header reports 289 actual enrollment. The adjusted between-group difference in change in the log-transformed C-peptide AUC measure at month 6 was −0.133 (95% CI −0.334 to 0.068; P=0.19582). It did not favor a demonstrated benefit. The termination reason is protocol-defined futility.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States, European Union, Other regions. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read this trial’s review notes for the checks completed and what remains unresolved. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- 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
The full picture
What the study asks
A phase 2 randomized trial of oral ladarixin in recently diagnosed T1D was stopped for futility. Results posted on 31 August 2026 do not show a C-peptide benefit over placebo.
Who it involves
Participants aged 14–45, starting study drug within 180 days of first insulin, with an islet autoantibody, fasting C-peptide below 0.205 nmol/L and stimulated C-peptide above 0.2 nmol/L. Enrollment is closed. This is a summary; the full registry lists additional criteria.1
Design and timing
The registry lists 289 participants (actual enrollment). Primary completion: 2025-03-31 (actual). Study completion: 2025-10-21 (actual). Estimated dates can change and do not mean results are available.1
Evidence and limits
The posted primary analysis includes 140 participants (94 ladarixin, 46 placebo), whereas the registry header reports 289 actual enrollment. The adjusted between-group difference in change in the log-transformed C-peptide AUC measure at month 6 was −0.133 (95% CI −0.334 to 0.068; P=0.19582). It did not favor a demonstrated benefit. The termination reason is protocol-defined futility.
The registry describes the primary analysis as change in log(AUC + 1), despite displaying a physical-unit label. These values should not be read as an untransformed percentage change in insulin production. The sample-size discrepancy is retained explicitly rather than treating the header total as the analyzed population.1
References
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ClinicalTrials.gov. NCT04628481. Record checked 16 September 2026; last update posted 2026-08-31. https://clinicaltrials.gov/study/NCT04628481 ↩ ↩2 ↩3
Sources
- [1]A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function (NCT04628481) · registry — Protocol and current registry status checked 16 September 2026.