A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Start Date
2/2/2026
Completion Date
12/31/2027
Summary
Rationale: LTI-03 is an experimental medication breathed into the lungs using an inhaler. It is being studied for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is a progressive, fatal lung disease caused by the death of lung cells involved in oxygen uptake and by progressive fibrosis (scarring) of the lungs. As the disease progresses, patients experience loss of lung function and increased breathing problems. LTI-03 is hypothesized to treat IPF by protecting and restoring the function of the oxygen uptake cells and by controlling lung fibrosis which may result in improving lung scarring. The purpose of this research is to evaluate LTI-03 including: its safety, whether it causes side effects, whether it improves lung scarring, and whether it improves IPF symptoms. LTI-03 will be compared to placebo in patients diagnosed with IPF within the last 5 years. Patients on a stable dose of nintedanib, pirfenidone, or nerandomilast (if available by prescription) may participate. Trial Design: This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study that includes a 28-day Screening Period, a 24-week Treatment Period, and 4-week Follow-up Period. Study Assessments: Up to 9 visits to the study clinic will be required. Safety and tolerability will be evaluated with the following assessments: physical examination; collection of vital sign data (heart rate, blood pressure, respiratory rate and peripheral oxygen saturation \[SpO2\] via pulse oximetry); heart data collected by 12-lead electrocardiogram; and collection of blood samples for safety laboratory tests. In addition, participants will be asked about any adverse events (side effects) they have experienced between clinic visits, if they have changed any medications, and if they are able to properly use their study drug inhaler. Participants will undergo a lung function test (spirometry) at every visit, which will be used to evaluate both safety and efficacy. Another test measuring the diffusion capacity of the lungs for carbon monoxide (DLCO) will be required at Screening only. Blood samples will also be collected at each visit to measure disease biomarkers. At select visits patients will be asked to complete the Living with Pulmonary Fibrosis questionnaire to evaluate their IPF symptoms. Participants will also undergo a specialized lung scan (HRCT) at Baseline and at the End of Treatment to measure changes in lung fibrosis. Interventions: LTI-03 and placebo are provided in powder-filled capsules that participants will self- administer using an inhaler. Placebo capsules look like LTI-03 capsules but have no active ingredients. Approximately 120 participants will be randomly assigned in a blinded manner to one of study drug treatment groups.
Eligibility Criteria
Age Range: 40 years to No maximum
Interventions
LTI-03
Dry Powder Inhaler
Placebo
Conditions
Locations
UAB Lung Health Center
Birmingham, Alabama 35233
United States
Cedars Sinai Medical Center
Los Angeles, California 90048
United States
Paradigm Clinical Research Centers, LLC
San Diego, California 92108
United States
National Jewish Health
Denver, Colorado 80206
United States
Yale University School of Medicine
New Haven, Connecticut 06511
United States
Cleveland Clinic Florida
Weston, Florida 33331
United States
Indiana University
Indianapolis, Indiana 46202
United States
Henry Ford Health
Detroit, Michigan 48202
United States
The Lung Research Center, LLC
Chesterfield, Missouri 63017
United States
University of Kansas Medical Center
Kansas City, Missouri 66160
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45267
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
El Paso Pulmonary Association
El Paso, Texas 79902
United States
Baylor College of Medicine
Houston, Texas 77030
United States
University of Utah
Salt Lake City, Utah 84108
United States
Westmead Hospital
Westmead, New South Wales 2145
Australia
Launceston Respiratory and Sleep Centre
Launceston, Tasmania 7250
Australia
Thoraxklinik-Heidelberg gGmbH Studienzentrum ThoraxKliPS
Heidelberg, Baden-Wurttemberg 69126
Germany
Agaplesion Evangelisches Krankenhaus Mittelhessen
Giessen, Hesse 35398
Germany
Twoja Przychodnia NCM
Nowa Sól, Lubusz Voivodeship 67-100
Poland
Instytut Gruzlicy i Chrob Pluc
Warsaw, Poland 01-138
Poland
Salus Aegroti Praktyka Lekarska dr n. med. Grzegorz Gąsior
Sosnowiec, Silesian Voivodeship 41-208
Poland
Birmingham Chest Clinic
Birmingham, Birmingham B91 2JL
United Kingdom
Queen Elizabeth Hospital Birmingham
Edgbaston, Birmingham B15 2GW
United Kingdom
Royal Papworth Hospital
Trumpington, Cambridge CB2 0AY
United Kingdom
Royal Devon and Exeter Hospital
Exeter, Devon EX2 5DW
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland EH16 4SA
United Kingdom
Royal Brompton Hospital
London, SW3 6HP
United Kingdom