Phase 2 Study to Test Oral PIPE-791 for Safety and Effectiveness in Adults with Idiopathic Pulmonary Fibrosis

What this Trial Is About

Researchers are evaluating the effects of PIPE-791, an oral drug, in adults diagnosed with Idiopathic Pulmonary Fibrosis IPF. This Phase 2, randomized, double-blind, placebo-controlled study aims to assess the efficacy, safety, tolerability, and how the drug moves through the body in participants with IPF, whether or not they are on background treatment. Approximately 324 participants will join this global study to better understand how PIPE-791 may impact lung function in this condition. Participants are randomly assigned to one of three groups two different daily oral doses of PIPE-791 or a matching placebo. The treatment period lasts 26 weeks, during which participants take their assigned tablets daily. The entire study duration can extend up to 36 weeks, including time for screening before treatment begins and follow-up after treatment ends. During the study, participants undergo lung function tests, including measuring forced vital capacity FVC at baseline and various points up to Week 26 to assess changes. Researchers will also monitor safety and side effects through reported adverse events up to Week 30. Additional assessments include lung imaging with high-resolution CT scans and other lung function measures. Participants will be followed throughout the study with scheduled visits to collect data on how they respond to the treatments and any potential side effects.

Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis