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

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What is this trial about?

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

This study focuses on patients with Idiopathic Pulmonary Fibrosis, a condition that causes scarring of the lung tissue. The research evaluates a new medication called LTI-03, which is delivered through inhalation using a special dry powder inhaler device. Some participants will receive LTI-03, while others will receive a placebo containing lactose monohydrate.

The purpose of this research is to determine if LTI-03 is safe and well-tolerated by patients who have been diagnosed with Idiopathic Pulmonary Fibrosis within the last 5 years. The medication will be tested in patients who may already be receiving standard treatment for their condition. The study will last for 24 weeks, during which participants will need to use an inhaler device to take their assigned medication.

Throughout the study, doctors will monitor patients' lung function using various tests including forced vital capacity measurements and high-resolution computed tomography scans of the chest. They will also track any side effects that may occur during treatment. The study will evaluate how well participants can breathe and how their quality of life may change while using the study medication.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening

    Your eligibility for the study will be confirmed based on specific criteria, including being 40 years or older and having been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) within the past 5 years

    A chest scan (HRCT) will be performed to confirm that lung fibrosis affects at least 10% of your lungs

    Your lung function will be tested to verify that your forced vital capacity (FVC) is at least 45% of predicted value

    Your ability to properly use the inhaler device will be evaluated

  2. Step 2

    Treatment period start

    You will be randomly assigned to receive either LTI-03 (study medication) or placebo (inactive substance) through inhalation

    The medication comes in the form of an inhalation powder in hard capsules

    If you are currently taking other medications for IPF (nintedanib, pirfenidone, or nerandomilast), you must have been on a stable dose for at least 12 weeks

  3. Step 3

    24-week treatment period

    Regular assessments will monitor your lung function through forced vital capacity (FVC) measurements

    A chest scan (HRCT) will be performed to measure changes in lung fibrosis

    Your experience with breathing difficulties and cough will be evaluated through a questionnaire

    Any side effects or health changes will be recorded

    Blood samples will be collected to measure markers related to IPF

  4. Step 4

    Final assessment

    The final evaluation will occur at week 24

    All previous measurements will be repeated to assess the treatment's effects

    Additional follow-up will continue through week 28 to monitor for any hospitalizations or other significant events

Who can join the trial?

8 criteria

  • Must be 40 years of age or older
  • Must be able and willing to provide written informed consent
  • Must have been diagnosed with IPF within the last 5 years, confirmed by a special chest scan (HRCT) showing that lung scarring affects at least 10% of the lungs and is more extensive than any emphysema present
  • Must have a lung function test (FVC) showing at least 45% of normal predicted value
  • Must have a breathing capacity test (DLCO) showing at least 30% of normal predicted value, measured within 8 weeks before starting the study
  • If currently taking medications like nintedanib, pirfenidone, or nerandomilast for IPF treatment, must have been on a stable dose for at least 12 weeks before joining the study
  • If previously took nintedanib, pirfenidone, or nerandomilast, must have stopped taking them at least 8 weeks before joining the study
  • Must be able to properly use the study inhaler device by yourself

Who cannot join the trial?

14 criteria

  • History of smoking within the past 6 months or more than 20 pack-years total (a pack-year is smoking one pack of cigarettes per day for one year)
  • Significant lung diseases other than Idiopathic Pulmonary Fibrosis (IPF), including active infections
  • Severe heart problems or uncontrolled high blood pressure
  • Major surgery within 3 months before starting the study
  • Current participation in other clinical trials or use of investigational drugs within 30 days
  • Severe liver problems or abnormal liver function tests
  • Severe kidney problems or abnormal kidney function tests
  • History of cancer within the past 5 years (except for successfully treated skin cancer)
  • Pregnant or breastfeeding women
  • Unable to perform breathing tests or use the inhaler device properly
  • Any condition that the study doctor believes would make participation unsafe
  • History of drug or alcohol abuse within the past year
  • Known allergies to the study medication or its components
  • Unstable or rapidly progressing IPF in the past 6 months
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Investigated drugs

  • LTI-03

    is an investigational inhaled medication derived from Caveolin-1-Scaffolding-Protein. It is being studied for treating patients with idiopathic pulmonary fibrosis (IPF), a condition that causes scarring of the lung tissue. The medication is designed to be inhaled directly into the lungs, where it may help address the underlying causes of lung tissue scarring.

  • Standard of Care (SoC) antifibrotic therapy

    refers to currently approved medications that help slow down the scarring process in the lungs. These are established treatments that patients may continue taking while participating in the trial.

What is already known about the treatment

LTI-03 - A novel investigational peptide derived from Caveolin-1-scaffolding protein that is administered through inhalation for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The medication is currently undergoing Phase 2 clinical trials to evaluate its safety, tolerability, and effectiveness in patients with IPF, including those who may be receiving standard antifibrotic therapy. As a therapeutic peptide, LTI-03 works by interacting with cellular pathways involved in the fibrotic process in lung tissue, potentially helping to slow down or prevent further scarring of the lungs.

Investigated diseases

Idiopathic Pulmonary Fibrosis – A chronic lung disease that causes progressive scarring (fibrosis) of lung tissue without a known cause. The condition primarily affects the lungs' tiny air sacs (alveoli) and the surrounding tissue, making them thick and stiff over time. As the scarring progresses, it becomes increasingly difficult for oxygen to pass from the lungs into the bloodstream. The disease typically develops gradually, with lung tissue becoming increasingly scarred and thickened. Symptoms usually include shortness of breath and a dry, persistent cough.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520715-13-00Protocol codeLTI-03-2001 (RENEW)Estimated enrolment120 patientsSponsorRein Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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