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

Part of paid clinical trials in Santa Barbara, California.

Sponsor
Insmed Incorporated
Study ID
NCT07481981
Phase
PHASE3
Status
Recruiting
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Conditions

  • Pulmonary Arterial Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Treprostinil Palmitil Inhalation Powder — DRUG
    Oral inhalation using a capsule-based dry powder inhaler device.
  • Placebo — DRUG
    Oral inhalation using a capsule-based dry powder inhaler device.

Study Details

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.

Key Dates

Start date
Jun 26, 2026
Status verified
Jun 2026
Primary completion
Dec 28, 2028
Completion
Jan 28, 2029

Study Design

Enrollment
344 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treprostinil Palmitil Inhalation Powder
    Participants will receive TPIP, once daily (QD), at a starting dose of 80 micrograms (μg) up to maximum tolerated dose (up to 1280 μg) for 24 weeks.
  • Placebo Comparator: Placebo
    Participants will receive a TPIP-matching placebo, QD, for 24 weeks.

Primary Outcome Measure

Change in 6-Minute Walk Distance (6MWD) Measured at 1 to 3 Hours Post-Dose From Baseline at Week 24 [ Time Frame: Baseline, Week 24 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
USA008Santa BarbaraCalifornia93105-
USA007AndersonSouth Carolina29621-

Find similar trials in Santa Barbara, CA

By research site
USA008· Santa Barbara, CAUSA007· Anderson, SC

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