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

Study acronym: PALM-PAH
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Trial sites expanded: 26 → 39 locations
  2. Trial sites expanded: 20 → 26 locations
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 1 of 11 entries
  3. Trial sites expanded: 3 → 20 locationsv5
  4. Study sites: 2 to 3
    • Start date changed from estimate of Jun 26, 2026 to Jul 21, 2026
    v4
  5. Study sites: 1 to 2v3
  6. Recruitment opened
    • Start date: Apr 17, 2026 to Jun 26, 2026
    • Study sites: 0 to 1
    • Eligibility criteria revised
    v2
  7. 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 compared with placebo on exercise capacity in adults with PAH.
Trial Details
NCT Number NCT07481981
Lead Sponsor Insmed Incorporated
Conditions
(from sponsor)		 Pulmonary Arterial Hypertension
Related terms Pulmonary Arterial Hypertension
Enrollment 344 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov