A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Once Daily Treprostinil Palmitil Inhalation Powder in Adults With Pulmonary Arterial Hypertension

What this Trial Is About

Researchers are evaluating the effects of once daily treatment with Treprostinil Palmitil Inhalation Powder (TPIP) compared with a placebo on exercise capacity in adults with pulmonary arterial hypertension (PAH). This phase 3 study aims to assess the efficacy and safety of TPIP over 24 weeks in participants diagnosed with PAH, including various subtypes according to established guidelines. The study is randomized, double-blind, and placebo-controlled, focusing on improving physical function in this population. Participants are assigned to receive either TPIP once daily, starting at 80 micrograms and increasing up to the maximum tolerated dose of 1280 micrograms, or a matching placebo for 24 weeks. TPIP and placebo are both administered via an oral inhalation using a capsule-based dry powder inhaler device. The trial includes a stable PAH therapy background, with participants continuing their current PAH medications during the study. Throughout the study, participants undergo assessments including the 6-minute walk distance test measured at baseline and week 24, along with various secondary evaluations like changes in functional class, biomarker levels, symptom questionnaires, and heart function measurements. Safety and drug plasma concentrations are monitored at multiple time points. The total participation period includes 24 weeks of treatment and follow-up, with detailed measures to monitor clinical worsening and overall health status.

A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)