NCT05176951

A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Insmed Incorporated · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and tolerability of treprostinil palmitil inhalation powder (TPIP) compared with placebo

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	Treprostinil Palmitil	Oral inhalation using a capsule-based dry powder inhaler device.
DRUG	Placebo	Oral inhalation using a capsule-based dry powder inhaler device.

Timeline

• Start date: 2022-12-22
• Primary completion: 2024-03-14
• Completion: 2024-03-14
• First posted: 2022-01-04
• Last updated: 2025-03-17

Locations

25 sites across 7 countries: Argentina, Australia, Belgium, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study