Clinical Research Directory

Inclusion Criteria: * Is ≥40 years of age at the time of informed consent. * Meets the diagnostic criteria of IPF American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) 2022 guidelines. * Has a maximum time from initial IPF diagnosis of 7 years. * Has no prior exposure to pirfenidone or LYT-100, and has \<12 months of prior exposure to nintedanib or any other approved antifibrotic therapies. * Has definite or probable unusual interstitial pneumonia (UIP) on HRCT, performed within 12 months prior to Visit 1 and confirmed by the central reader. * Has an FVC ≥45% of predicted normal at Visit 1. Exclusion Criteria: * Has, in the opinion of the Investigator, significant clinical worsening of IPF between Visit 1 and Visit 2. * Has been hospitalized within 3 months prior to Visit 1 for acute exacerbation of IPF or other significant respiratory complication. * Has prebronchodilator forced expiratory volume in 1 second (FEV1)/FVC \<0.7 at Visit 1. * Has a greater extent of emphysema vs fibrosis on the most recent HRCT scan as confirmed by the central reader. * Has a diagnosis of any condition that could be an explanation for interstitial lung disease (ILD). * Has a major extrapulmonary condition that could affect spirometry. * Has a current diagnosis of other relevant respiratory disorders. * Has significant pulmonary hypertension (PH). * Has had a lung transplant. * Has cardiovascular disease. * Has underlying chronic liver disease/impairment. * Has relevant chronic or acute infections including active viral hepatitis or poorly controlled HIV. * Has had any major surgical procedures performed within 6 weeks prior to Visit 1 or is planning to have a major surgical procedure during the study. * Has any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1. * Has any of the following laboratory abnormalities at Visit 1: * Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \>1.5 × upper limit of normal (ULN). * Total bilirubin \>1.5 × ULN. Exceptions may be made on a case-by-case basis for participants with Gilbert's syndrome in consultation with the Medical Monitor. * Creatinine clearance \<30 mL/min calculated by Cockcroft-Gault formula. * Is currently taking prednisone at a steady dose \>10 mg/day or equivalent (a steady dose ≤10 mg/day is not exclusionary but the individual must be on a stable dose for at least 30 days prior to Visit 2). * Use of any tobacco or combustible cannabis products within 3 months prior to Visit 1 or is unable to refrain from use during the trial. * Has known symptoms of dysphagia, difficulty in swallowing capsules or tablets, or has had a total gastrectomy. * Is currently enrolled in another clinical study (except observational/registry or biobank studies) or has used any investigational drug or device within 90 days prior to Visit 1. * Has ever received stem cell therapy for the treatment of pulmonary fibrosis. * Is currently pregnant, breastfeeding, or is planning to become pregnant during the study. * Has had any prior exposure to LYT-100 or pirfenidone (even one dose).