A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis

This study is looking for men and women aged 40 or older who have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) in the last five years. Your lung scans need to show that at least 10% of your lung has fibrosis (scarring), and you must currently have certain levels of lung function.

If you are already taking medicines like nintedanib, pirfenidone, or nerandomilast for your IPF, you can still participate, but you must have been on a stable dose for at least 12 weeks before starting the study. If you stopped taking these medicines previously, you must have done so at least 8 weeks before the study begins. You also need to be able to use an inhaler properly.

However, you cannot take part if you have certain other lung conditions, are a smoker, have had a recent flare-up of your IPF, or have serious kidney problems. You also can't be taking certain other medications or participating in another clinical study.

If you decide to take part, you'll first have a screening period lasting about 4 weeks to check if you're suitable. Once confirmed, you'll be given either LTI-03 or a placebo, both delivered through a dry powder inhaler that you'll use yourself. This treatment period will last for 24 weeks.

During the study, you'll need to visit the study clinic up to 9 times. At these visits, doctors will monitor your health by checking your heart rate, blood pressure, and breathing, performing physical exams, and taking blood samples. You'll also have regular lung function tests to see how your lungs are working. On some visits, you'll fill out questionnaires about your symptoms, and you'll have special lung scans at the start and end of your treatment to check for changes in lung scarring.

After your 24-week treatment, there will be a final 4-week follow-up period. The total time you'd be involved in the study is about 29 weeks.