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

What is this study about?

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.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Agaplesion Evangelisches Krankenhaus Mittelhessen gGmbH	Giessen	Germany

Other Sites

Site Name	City	Country
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH	Essen	Germany
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.	Nowa Sol	Poland
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Uvdtsbswmt Mtbuztf Cjzhan Hlypdpyfqgmzhnzqt	Hamburg	Germany
Ngbseobx Iseirdwax Om Tdljajfhamvo Aqy Lrid Dqiptmbr	Warsaw	Poland
Pfmrbl Gdmljpgh Gbfzeq Meqssar Kzxscrni suhk	Sosnowiec	Poland

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	19.05.2026
Poland	Recruiting	19.05.2026

Trial locations

Investigated drugs:

LTI-03

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.

Investigated diseases:

Idiopathic pulmonary fibrosis

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 ID:

2025-520715-13-00

Protocol code:

LTI-03-2001 (RENEW)

NCT ID:

NCT06968845

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?