Effect of the experimental drug ladarixin administered orally at a dose of 400 mg twice a day on insulin sensitivity. A phase 2, randomized, double-blind, placebo-controlled explorative study in obese patients with pre-diabetes eligible to bariatric surgery.

Effect of oral ladarixin 400 mg twice a day on insulin sensitivity. A phase 2, randomized, double-blind, placebo-controlled explorative study in obese patients with pre-diabetes eligible to bariatric surgery. - Ladarixin in obese pre-diabetic patients eligible to bariatric surgery

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003296-18-IT

Enrollment

Registered

2021-05-24

Start date

2020-12-30

Completion date

Unknown

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity and pre-diabetes MedDRA version: 21.1 Level: LLT Classification code 10036481 Term: Pre-diabetes System Organ Class: 100000004861 MedDRA version: 20.0 Level: LLT Classification code 10065542 Term: Prediabetes System Organ Class: 100000004861

Interventions

Product Name: Ladarixin Product Code: [Ladarixin] Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ladarixin CAS Number: 865625-56-5 Current Sponsor code: DF 2156A Concentration unit: mg millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male and female patients aged 30-65 years, inclusive; - Body Mass Index (BMI) >35 kg/m2; - Presence of pre-diabetes (fasting glucose 100-125 mg/dL, inclusive; HbA1c 5.7-6.5%, inclusive); - Eligible to bariatric surgery as per any other criteria dictated by the Surgery Units; - Patients who have given written informed consent prior of any study-related procedure not part of standard medical care; - Patients able to comply with all protocol procedures for the duration of the study, including scheduled follow-up visits and examinations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7

Exclusion criteria

Exclusion criteria: - Moderate to severe renal impairment (creatinine clearance (CLcr) 3 x upper limit of normal and increased total bilirubin >3 mg/dL [>51.3 µmol/L]); - Hypoalbuminemia (serum albumin 470 msec; - History of any past or current clinically significant cardiovascular disease/abnormality; - Known hypersensitivity to non-steroidal antiinflammatory drugs; - Presence of any other clinical condition/disease that the PI believes might compromise patient’s safety or otherwise confound study outcome; - Patients on treatment with phenytoin, warfarin, sulphanylurea hypoglycemics and high dose of amitriptyline (>50 mg/day); - Previous (within 2 weeks prior to randomization) treatment with any medications known to influence glucose tolerance - Pregnant or breast feeding women. Unwillingness to use effective contraceptive measures up to 2 months after the end of study drug administration (females and males).

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to explore whether ladarixin may improve insulin sensitivity in patients with pre-diabetes eligible to bariatric surgery due to obesity. The safety of ladarixin in the specific clinical setting will be also evaluated.;Secondary Objective: not applicable;Primary end point(s): Efficacy Endpoints: • Insulin Sensitivity Index-Matsuda (ISI-M) from 3h-(OGTT) • Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) • C-peptide AUC from 3h-OGTT • Proinsulin : C-peptide ratio • Proportion of patients with Impaired Glucose Tolerance (IGT) • Hormones (adipokine, incretines, etc.) • Inflammatory chemokines/cytokines and CRP • Gut (faeces) microbiome/microbiota “Diversity” • Abdominal obesity (waist and waist/hip circumference) • Adipocyte characterization (exploratory endpoint) Safety Endpoints: • Blood pressure and heart rate • Safety laboratory tests [haematology (haematocrit, haemoglobin, red blood cells, platelets, white blood cells, differential white blood cells count) and clinical chemistry (sodium, potassium, serum creatinine, serum albumin, total bilirubin, ALT, AST)] • Incidence of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs);Timepoint(s) of evaluation of this end point: All efficacy endpoints will be measured at the follow-up visit (day 71-75), ideally within 2 days of the last dose of IMP. The surgery will be performed within one week of the end of the treatment. All safety endpoints will be assessed at the end of treatment cycle 1, within 7 days of the end of the cycle, and at follow-up (day 71-75), ideally within 2 days of the last dose of the study treatment. TEAEs / TESAEs will be recorded during the study, starting on Day 1 of treatment.	—

Measure

Time frame

Main Objective: The main objective is to explore whether ladarixin may improve insulin sensitivity in patients with pre-diabetes eligible to bariatric surgery due to obesity. The safety of ladarixin in the specific clinical setting will be also evaluated.;Secondary Objective: not applicable;Primary end point(s): Efficacy Endpoints: • Insulin Sensitivity Index-Matsuda (ISI-M) from 3h-(OGTT) • Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) • C-peptide AUC from 3h-OGTT • Proinsulin : C-peptide ratio • Proportion of patients with Impaired Glucose Tolerance (IGT) • Hormones (adipokine, incretines, etc.) • Inflammatory chemokines/cytokines and CRP • Gut (faeces) microbiome/microbiota “Diversity” • Abdominal obesity (waist and waist/hip circumference) • Adipocyte characterization (exploratory endpoint) Safety Endpoints: • Blood pressure and heart rate • Safety laboratory tests [haematology (haematocrit, haemoglobin, red blood cells, platelets, white blood cells, differential white blood cells count) and clinical chemistry (sodium, potassium, serum creatinine, serum albumin, total bilirubin, ALT, AST)] • Incidence of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs);Timepoint(s) of evaluation of this end point: All efficacy endpoints will be measured at the follow-up visit (day 71-75), ideally within 2 days of the last dose of IMP. The surgery will be performed within one week of the end of the treatment. All safety endpoints will be assessed at the end of treatment cycle 1, within 7 days of the end of the cycle, and at follow-up (day 71-75), ideally within 2 days of the last dose of the study treatment. TEAEs / TESAEs will be recorded during the study, starting on Day 1 of treatment.

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Countries

Italy

Contacts

Public ContactClinical Department

CROS NT Srl

alessia.sandri@crosnt.com0458205875

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026