CLINICAL TRIALS PROFILE FOR LADARIXIN
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Clinical Trials for Ladarixin
Trial ID | Title | Status | Sponsor | Phase | Summary |
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NCT02814838 ↗ | A Phase 2, Multicentre, Randomized, Double-blind, Placebo-controlled Study in Patients With New-onset Type 1 Diabetes | Completed | Dompé Farmaceutici S.p.A | Phase 2 | The objective of this clinical trial is to investigate whether ladarixin has sufficient activity (preservation of β-cell function and slow-down of the progression of T1D) to warrant its further development (proof of concept trial). The safety of ladarixin in the specific clinical setting will be also evaluated. The study is a phase 2, multicentre, double-blind study. 72 patients with new-onset type 1 diabetes (T1D) were planned to be involved, randomly (2:1) assigned to receive either ladarixin treatment (400 mg b.i.d. for 3 cycles of 14 days on/14 days off - treatment group) or placebo (control group). Recruitment was competitive among the study sites, until the planned number of patients was enrolled. A total of 76 patients were actually recruited. |
NCT04628481 ↗ | A Study of Oral Ladarixin in New-onset Type 1 Diabetes and a Low Residual β-cell Function | Recruiting | Dompé Farmaceutici S.p.A | Phase 3 | The objective of this clinical trial is to assess whether ladarixin treatment is effective in preserving beta-cell function and delaying the progression of type 1 diabetes (T1D) in adolescent and adult patients. The safety of ladarixin in the specific clinical setting will be also evaluated. |
NCT04854642 ↗ | A Single Dose Study About the Influence of Food on the Oral Bioavailability of Ladarixin Capsule in Healthy Volunteers | Completed | Dompé Farmaceutici S.p.A | Phase 1 | Primary objective: - to investigate the effect of food on the bioavailability of DF 2156Y after single dose administration of 400 mg of ladarixin to healthy male and female volunteers under fed and fasting conditions. Secondary objectives: - to investigate the effect of gender on the bioavailability of DF 2156Y and its metabolites (DF 2108Y and DF 2227Y) after single dose administration of 400 mg of ladarixin to healthy male and female volunteers - to evaluate safety and tolerability of a single dose administration of ladarixin 400 mg to healthy male and female volunteers. |
NCT04899271 ↗ | A Study to Assess Efficacy/Safety of Ladarixin in Type 1 Diabetes Patients With Preserved ß-cell Function at Baseline. | Recruiting | Dompé Farmaceutici S.p.A | Phase 2 | The objectives of this clinical trial are: - to evaluate whether a 12 month treatment with ladarixin is effective to improve glycemic control in newly diagnosed T1D adult patients with preserved beta-cell function. - to evaluate the safety of ladarixin in the specific clinical setting |
NCT05035368 ↗ | Ladarixin as Adjunctive Therapy to Improve Insulin Sensitivity and Glucometabolic Outcomes in Type 1 Diabetes | Not yet recruiting | Dompé Farmaceutici S.p.A | Phase 2 | 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. |
NCT05368402 ↗ | Randomized, Double-blind, Clinical Trial on Ladarixin Adjunctive Therapy to Improve Glycemic Control in Type 1 Diabetes. | Not yet recruiting | Dompé Farmaceutici S.p.A | Phase 2 | Primary objective: To determine whether oral ladarixin versus placebo adjunctive therapy improves glycemic control in overweight, insulin resistant (IR) adult subjects with type 1 diabetes (T1D). Secondary objectives: To ascertain the effect of ladarixin on glycemic variability as per CGM derived parameters. To determine the safety of oral ladarixin versus placebo adjunctive therapy in overweight, IR adult subjects with T1D. Exploratory objectives (if site is able and deems appropriate to accommodate and conduct these objectives): To determine the effects on insulin sensitivity and circulating markers of inflammation (leukocytes and inflammatory cytokines). Glycemic variability by additional CGM parameters. eGDR and BMI assessments. |
NCT05815173 ↗ | Ladarixin With Sotorasib in Advanced NSCLC - Phase I | Not yet recruiting | NYU Langone Health | Phase 1 | This is a phase I, open-label, study of twice-daily oral ladarixin in patients with advanced KRAS G12C mutant non-small cell lung cancer (NSCLC) with sotorasib. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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