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LTI-03

Clinical trials are investigating LTI-03 in people with idiopathic pulmonary fibrosis (IPF), a long-term lung disease that causes scarring. The study aims to assess safety, tolerability, and early signs of benefit in adults with IPF, including some who may already be on standard antifibrotic treatment.

Table of Contents

Trial overview

The available clinical trial for LTI-03 is called RENEW and is a Phase 2 study in people with idiopathic pulmonary fibrosis (IPF).[1] It is an interventional study, which means researchers give a study treatment and then measure what happens.[1] The trial is authorised and plans to enroll 120 participants.[1]

Who can join the study

This study is for patients with IPF who were diagnosed within 5 years before screening.[1] The brief summary also says that some participants may already be receiving standard of care antifibrotic therapy, meaning their usual treatment for lung scarring may continue while they take part in the study.[1]

What is being measured

The main endpoint, or main result the study wants to measure, is the incidence of treatment-emergent adverse events (TEAEs) from Day 1 through Week 24.[1] TEAEs are medical problems that start after treatment begins or get worse during the study.[1] The trial title also says it will look at safety, tolerability, and efficacy, so the researchers want to know whether the treatment is safe, how well people can take it, and whether it shows signs of helping IPF.[1]

Study design and treatment groups

The study compares inhaled LTI-03 with a placebo.[1] The trial description lists the study drug as LTI-03 10 mg by inhalation and the placebo as InhaLac® 500, which is micronized lactose monohydrate.[1] A placebo is a look-alike treatment used for comparison, so researchers can better understand the effect of the study drug.[1]

What the phase means

Phase 2 trials are usually done after early safety testing and are meant to learn more about how a treatment performs in a specific patient group.[1] In this study, the focus is on people with IPF, so the results may help show whether LTI-03 deserves further study in this disease.[1]

Key patient terms

  • Idiopathic pulmonary fibrosis (IPF) means long-term scarring of the lungs, and the cause is not known.[1]

  • Screening is the check done before joining a trial to see if a person meets the study rules.[1]

  • Enrollment is the number of people the study plans to include, which is 120 in this trial.[1]

  • Safety means looking for unwanted medical problems during the study.[1]

  • Tolerability means how well participants can take the treatment without too much trouble.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06968845 Phase 2 Idiopathic Pulmonary Fibrosis Authorised 120

FAQ

  • What is being studied in LTI-03 clinical trials? The trial is studying whether inhaled LTI-03 is safe, tolerable, and effective in people with idiopathic pulmonary fibrosis. It also compares LTI-03 with a placebo, which is a look-alike treatment with no active study drug.
  • Who can take part in the LTI-03 trial? The trial is for adults diagnosed with idiopathic pulmonary fibrosis within 5 years before screening. Some participants may already be receiving standard antifibrotic therapy.
  • What phase is the LTI-03 trial? The listed study is a Phase 2 trial. Phase 2 studies usually look more closely at safety and whether a treatment shows signs of helping the condition.
  • What condition is the trial focused on? The trial focuses on idiopathic pulmonary fibrosis, often called IPF. This is a chronic lung disease that leads to scarring in the lungs and can make breathing harder over time.
  • What outcome is the trial measuring? The main outcome is the number of treatment-emergent adverse events, also called TEAEs, from Day 1 through Week 24. TEAEs are health problems that start or get worse after treatment begins.

Ongoing Clinical Trials on LTI-03

  • Study of inhaled LTI-03 for safety and effectiveness in patients with Idiopathic Pulmonary Fibrosis who may be receiving standard antifibrotic therapy

    Recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Germany Poland

Glossary

  • Idiopathic Pulmonary Fibrosis (IPF): A long-term lung disease that causes scarring in the lungs. 'Idiopathic' means the cause is not known.
  • Phase 2: A stage of clinical research that looks more closely at safety and early signs that a treatment may help.
  • Safety: Whether a treatment causes unwanted medical problems.
  • Tolerability: How well people can take a treatment without it causing too many problems.
  • Efficacy: How well a treatment works for the condition being studied.
  • Placebo: A look-alike treatment that does not contain the active study drug. It is used for comparison.
  • Standard of Care (SoC): The usual treatment or care that is commonly given for a condition.
  • Antifibrotic therapy: Treatment used to slow fibrosis, which means scarring in the lungs.
  • Interventional study: A study where researchers give a treatment and then measure what happens.
  • Treatment-emergent adverse events (TEAEs): Medical problems that begin or become worse after the study treatment starts.
  • Screening: The process used to check whether a person can join a clinical trial.
  • Enrollment: The number of people planned to join the study.

References