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A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function

NCT04628481 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2025-12-17

No results posted yet for this 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.

Conditions

  • Recent Onset type1 Diabetes

Interventions

DRUG

Ladarixin

Oral ladarixin twice a day for 13 cycles

DRUG

Placebo

Oral placebo twice a day for 13 cycles

Sponsors & Collaborators

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-12
Primary Completion
2025-03-31
Completion
2025-10-21
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Georgia
  • Germany
  • Israel
  • Italy
  • Serbia
  • Slovenia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04628481 on ClinicalTrials.gov