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Study on the Effects and Safety of Ladarixin for Adults and Adolescents with Recent Onset Type 1 Diabetes

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects and safety of a medication called Ladarixin in individuals with Type 1 Diabetes that has recently developed. Type 1 Diabetes is a condition where the body's immune system attacks the cells in the pancreas that produce insulin, a hormone that helps control blood sugar levels. The study aims to see if Ladarixin can help preserve the function of these insulin-producing cells and slow down the progression of the disease. Participants in the study will either receive Ladarixin or a placebo, which is a substance with no active medication.

The study will involve taking Ladarixin in the form of a hard capsule, with a dosage of 400 mg taken twice a day. The treatment period will last for up to 12 months. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the medication. These check-ups will include various tests to assess how well the insulin-producing cells are functioning and to ensure the safety of the participants.

The main goal of the study is to determine if Ladarixin can help maintain the function of the insulin-producing cells in the pancreas and delay the worsening of Type 1 Diabetes. Additionally, the study will evaluate the safety of Ladarixin in this specific group of patients. Participants will be closely monitored for any changes in their condition and any potential side effects of the treatment. The study will provide valuable information on whether Ladarixin could be a beneficial treatment option for people with recent onset Type 1 Diabetes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, recent onset of type 1 diabetes, and the presence of specific diabetes-related antibodies.

    A fasting C-peptide test is performed to measure the level of a protein that indicates how well the pancreas is producing insulin.

  2. Step 2

    Randomization and medication

    Participants are randomly assigned to receive either Ladarixin or a placebo. This is a double-blind study, meaning neither the participants nor the researchers know who receives the actual medication.

    Ladarixin is administered orally in the form of hard capsules. The dosage is 400 mg taken twice a day.

  3. Step 3

    Treatment phase

    The treatment phase involves taking the assigned medication for a specified duration. Regular follow-up visits are scheduled to monitor health and response to the treatment.

    Participants continue their usual insulin therapy as needed, and adjustments are made based on regular assessments.

  4. Step 4

    Monitoring and assessments

    Throughout the study, various assessments are conducted to evaluate the effect of the treatment. This includes measuring changes in C-peptide levels, HbA1c levels, and insulin requirements.

    Continuous Glucose Monitoring (CGM) is used to track glucose levels over time, providing data on time in range and glucose variability.

  5. Step 5

    End of study evaluations

    At the end of the study, final evaluations are conducted to assess the overall impact of the treatment on beta-cell function and diabetes progression.

    Participants are informed of the study results and any potential implications for their ongoing diabetes management.

Who can join the trial?

8 criteria

  • Male and female patients aged 14-45 years can participate.
  • Patients must have a recent onset of Type 1 Diabetes, meaning they should receive the first dose of the study medication within 180 days from their first insulin administration.
  • Patients need to test positive for at least one diabetes-related auto-antibody. Auto-antibodies are proteins made by the immune system that mistakenly target the body's own tissues. Examples include anti-GAD, IAA (if tested within 10 days of starting insulin therapy), IA-2 antibody, or ZnT8.
  • Patients must require or have required insulin therapy at some point, either through separate injections under the skin or through a device that continuously delivers insulin under the skin.
  • Patients should have a fasting C-peptide level of less than 0.205 nmol/L. C-peptide is a substance made in the pancreas, and its level can indicate how much insulin the body is producing.
  • Patients must have some remaining beta-cell function, shown by a peak stimulated C-peptide level greater than 0.2 nmol/L. Beta cells are cells in the pancreas that make insulin. The test to measure this should not be done within one week after recovering from a diabetic ketoacidosis event, which is a serious diabetes complication.
  • Patients must be able to follow all study procedures for the entire duration of the study, including attending scheduled follow-up visits and examinations.
  • Patients must provide written informed consent before any study-related procedures that are not part of standard medical care. For participants under 18, they must give their agreement to participate, and specific consent is needed from adolescents for a detailed analysis of how the drug is processed in the body.

Who cannot join the trial?

5 criteria

  • Patients who have had Type 1 Diabetes for a long time cannot participate. The study is for those with a recent onset of the condition.
  • Individuals who are not in the specified age range for the study cannot join. The study is for adolescents and adults.
  • People who are not comfortable with the treatment or have concerns about the safety of the medication being tested should not participate.
  • Participants who are part of a vulnerable population, meaning they might need special protection or care, may not be eligible.
  • Both male and female participants are considered, but specific health conditions or factors might exclude someone.
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Investigated drugs

Ladarixin is an oral medication being studied for its potential to help preserve the function of beta cells in the pancreas. Beta cells are responsible for producing insulin, which is crucial for regulating blood sugar levels. In this trial, ladarixin is being tested to see if it can delay the progression of type 1 diabetes in patients who have recently been diagnosed and have low beta-cell function. The study also aims to evaluate the safety of ladarixin in these patients.

What is already known about the treatment

Ladarixin – Ladarixin is administered orally in the form of tablets, taken twice a day. It is currently being studied in clinical trials, specifically in a phase 2 trial, to evaluate its effectiveness and safety in patients with recent onset Type 1 Diabetes. The main therapeutic indication for ladarixin is to preserve beta-cell function and delay the progression of Type 1 Diabetes. At the molecular level, ladarixin works by inhibiting certain inflammatory pathways that contribute to the destruction of insulin-producing beta cells in the pancreas. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Type 1 Diabetes – Type 1 Diabetes is a chronic condition where the pancreas produces little or no insulin due to the immune system attacking and destroying the insulin-producing beta cells. This disease often begins in childhood or adolescence but can also develop in adults. As the disease progresses, individuals experience high blood sugar levels, which can lead to symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. Over time, if not managed properly, it can lead to complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The progression of Type 1 Diabetes requires careful monitoring of blood sugar levels and lifestyle adjustments to manage the condition effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513560-26-00Protocol codeLDX0319Estimated enrolment289 patientsSponsorDompe' Farmaceutici S.p.A.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).