Phase 3 Study of L606 Inhalation for Pulmonary Hypertension Due to Interstitial Lung Disease Evaluating Safety and Effectiveness in Adults Ages 18 to 80

What this Trial Is About

Researchers are evaluating the safety and effects of L606 in adults with pulmonary hypertension caused by interstitial lung disease PH-ILD, WHO Group 3. This phase 3 study aims to determine if L606 helps improve the distance people can walk in six minutes, an important test for lung and heart health. The research also looks at how long it takes for the condition to worsen while taking L606 compared to placebo. Participants are randomly assigned to receive either L606, a liposomal form of treprostinil inhaled through a study-issued nebulizer, or a matching placebo with no active medicine. After the initial blinded study period, participants may join an open-label extension where everyone receives L606. Doctors monitor the effects and any side effects closely throughout the study. During the trial, participants will undergo six-minute walk tests at various times to measure their walking distance and track changes. Researchers will also watch for hospitalizations, deaths related to lung or heart issues, lung transplants, and significant declines in walking ability. Safety is monitored regularly to ensure L606 is tolerable. The study is expected to continue until late 2031, with multiple assessments throughout this period.

A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD