Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Study acronym: PALM-ILD
StatusRecruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Study sites: 185 to 186
  2. Primary endpoint(s) modified
    • Trial sites expanded: 145 → 185 locations
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints revised (8)
  3. Trial sites expanded: 109 → 145 locationsv15
  4. Trial sites expanded: 96 → 109 locationsv14
  5. Trial sites expanded: 68 → 96 locationsv13
  6. Trial sites expanded: 49 → 68 locationsv12
  7. Trial sites expanded: 30 → 49 locationsv11
  8. Study sites: 26 to 30v10
  9. Study sites: 16 to 26v9
  10. Site details revised at 1 of 16 sitesv8
  11. Study sites: 12 to 16
    • Start date changed from estimate of Jan 15, 2026 to Jan 7, 2026
    v7
  12. Study sites: 9 to 12v6
  13. Study sites: 5 to 9v5
  14. Site details revised at 2 of 5 sitesv4
  15. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 10, 2025 to Jan 15, 2026
    • Study sites: 0 to 5
    v3
  16. Start date: Oct 1, 2025 to Nov 10, 2025v2
  17. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Insmed Incorporated
15 trials monitored
See 1 trial at risk
Hypertension
1,935 trials monitored
See 96 trials at risk
The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults with PH-ILD.
Trial Details
NCT Number NCT07179380
Lead Sponsor Insmed Incorporated
Conditions
(from sponsor)		 Pulmonary Hypertension, Interstitial Lung Disease
Related terms Hypertension, Pulmonary, Lung Diseases, Interstitial
Enrollment 344 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov