Phase 2 Study of Inhaled LTI-03 for Treating Idiopathic Pulmonary Fibrosis in Adults Aged 40 and Older

What this Trial Is About

Researchers are evaluating LTI-03, an experimental inhaled medication, for the treatment of Idiopathic Pulmonary Fibrosis IPF, a progressive and fatal lung disease characterized by lung cell death and scarring that worsens breathing over time. This Phase 2 study aims to assess LTI-03s safety, side effects, impact on lung scarring, and symptom improvement compared to placebo in patients diagnosed within the last five years. Participants may be on stable doses of other approved IPF treatments like nintedanib, pirfenidone, or nerandomilast. Participants will be randomly assigned to receive either LTI-03 or a placebo, both delivered via inhaler capsules. The study includes a 28-day screening period, followed by a 24-week treatment phase, and a 4-week follow-up. About 120 participants will self-administer the study drug twice daily. Assessments include lung function tests, lung scans, blood samples for biomarkers, and symptom questionnaires. Participants will visit the clinic up to nine times during the study for safety checks including physical exams, vital signs, heart monitoring, and blood tests. Lung function will be tested regularly, and specialized lung scans will be done at baseline and end of treatment to measure fibrosis changes. Researchers will monitor adverse events and study drug use throughout. The main outcome is safety and tolerability measured by treatment-related side effects during the 24 weeks of treatment.

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