drugset / Trial / NCT05035368

Ladarixin as Adjunctive Therapy to Improve Insulin Sensitivity and Glucometabolic Outcomes in Type 1 Diabetes

NCT05035368 ↗

Phase 2 Withdrawn Dompé Farmaceutici S.p.A
RandomizedCrossoverQuadruple-blindTreatment

Summary

Objectives Primary study objective: To determine whether orally-administered ladarixin versus placebo adjunctive therapy improves insulin sensitivity in overweight, insulin-resistant (IR) type 1 Diabetic (T1D) adult subjects. Secondary study objectives: To determine whether orally-administered ladarixin versus placebo adjunctive therapy is safe and well-tolerated in overweight, IR T1D adult subjects.

Timeline

Start
2021-09-30
Primary completion
2023-06
Completion
2023-06

Outcome

Outcome not reported

Stopped (Enrollment): “Dompé decided to withdraw LDX0121 following an internal re-planning and an extensive review of the study design. At the time of withdrawal, no site had been activated and the drug had not been sent to investigators. No patients had been enrolled.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ladarixin Unknown 400 mg Oral