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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Insmed Incorporated
Study ID
NCT07179380
Phase
PHASE3
Status
Recruiting
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Conditions

  • Interstitial Lung Disease
  • Pulmonary Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
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 versus placebo on exercise capacity in adults with PH-ILD.

Key Dates

Start date
Jan 7, 2026
Status verified
May 2026
Primary completion
Dec 30, 2028
Completion
Dec 30, 2028

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) to maximum tolerated dose up to 1280 μg for 24 weeks.
  • Placebo Comparator: Placebo
    Participants will receive a placebo matching TPIP QD for 24 weeks.

Primary Outcome Measure

Change in 6MWD Measured at Peak Exposure From Baseline to Week 24 [ Time Frame: Baseline, Week 24 ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
USA010Los AngelesCalifornia900275969-
USA001Santa BarbaraCalifornia93105-4349-
USA006NaplesFlorida34102-5412-
USA026St. PetersburgFlorida33707-6129-
USA002Kansas CityKansas66160-
USA003BendOregon97701-
USA013PhiladelphiaPennsylvania19140-
USA008RichmondVirginia23230-

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