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Study of Treprostinil Palmitil Inhalation Powder for Pulmonary Arterial Hypertension

This study is looking at how well and how safely an inhaled medication called Treprostinil Palmitil Inhalation Powder works for people with pulmonary arterial hypertension (PAH), a type of high blood pressure in the lungs. Researchers want to see if taking this medicine once a day improves your ability to exercise compared to a placebo (an inactive substance). You might be able to join if you are between 18 and 75 years old and have been diagnosed with a specific type of PAH. The main way success will be measured is by how much your 6-minute walk distance changes after 24 weeks of treatment. The current status of this study is unclear, and it plans to enroll 344 participants.

Study design
This is an interventional study comparing Treprostinil Palmitil Inhalation Powder to a placebo. It plans to enroll 344 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your 6-minute walk distance will be measured at baseline and again at Week 24.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07481981

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

Recruiting
PHASE3Ages 18–75InterventionalTreatment
Insmed Incorporated
~344 participants
Updated 2026-09-16 on ClinicalTrials.gov
What's tested:Treprostinil Palmitil Inhalation PowderPlacebo

At a glance

Recruiting sites
26 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in 6-Minute Walk Distance (6MWD) Measured at 1 to 3 Hours Post-Dose From Baseline at Week 24
Measured over Baseline, Week 24

Conditions

Pulmonary Arterial Hypertension

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NCT07481981

Where you'd take part

This study runs at 26 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • ARG001

    Buenos Aires, Buenos Aires F.D., Argentinano site contact published

    Recruiting

  • ARG004

    Río Cuarto, Córdoba Province, Argentinano site contact published

    Recruiting

  • AUS002

    Camperdown, New South Wales, Australiano site contact published

    Recruiting

  • AUS003

    Westmead, New South Wales, Australiano site contact published

    Recruiting

  • ISR001

    Jerusalem, Israelno site contact published

    Recruiting

  • ISR003

    Tel Aviv, Israelno site contact published

    Recruiting

  • ISR004

    Petah Tikva, Israelno site contact published

    Recruiting

  • ISR005

    Ramat Gan, Israelno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Insmed Medical Information
[email protected]
18444467633
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Participants must have a diagnosis of World Health Organisation (WHO) Group 1 pulmonary hypertension (PAH) in any of the following subtypes, in accordance with European Society of Cardiology European Respiratory Society (ESC/ERS) Guidelines:
Idiopathic PAH
Heritable PAH
Drug/toxin-induced PAH
Connective tissue disease (CTD)-associated PAH
PAH associated with congenital heart disease-related to simple systemic-to-pulmonary shunt at least 1 year following repair.
PAH diagnosis for at least 3 months prior to Screening.
New York Heart Association (NYHA) or World Health Organization (WHO) functional class II-IV.
Participants must be on stable PAH therapy consisting of 1 to 3 medications from the following classes:
Endothelin receptor antagonists (eg, ambrisentan, bosentan, macitentan) for at least 90 days prior to Screening with the last 30 days on stable dose
Phosphodiesterase type 5 inhibitors (eg, sildenafil, tadalafil) for at least 90 days prior to Screening with the last 30 days on stable dose
Guanylate cyclase stimulator (eg, riociguat) for at least 90 days prior to Screening with the last 30 days on stable dose
Activin signaling inhibitor (e.g., sotatercept) for at least 6 months prior to Screening, with the last 3 months on stable dose and meeting all the following conditions:
no active clinically significant bleeding (eg, epistaxis and gingival bleeding requiring medical interventions) within the past 3 months.
no history of major bleeding events or risks (eg, gastrointestinal or intracranial bleeding) within the past 6 months.
platelet counts ≥100,000 per microlitre (μL) at Screening
For both 6-minute walk tests (6MWTs), the values of 6-minute walk distance (6MWD) should be ≥ 150 and ≤ 450 meters at Screening.
Right heart catheterization (RHC) at Screening (or within 6 months prior to Screening, if available). Prior RHC may be used provided there has been no change in background PAH therapy and doses. The RHC must meet all of the following hemodynamic criteria:
Mean pulmonary arterial pressure (PAP) \>20 millimetre of mercury (mmHg) at rest.
pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) ≤15 mmHg.
pulmonary vascular resistance (PVR) of ≥5 wood units (WU).

Exclusion

Diagnosis of PH WHO Groups 2, 3, 4, or 5, or subtypes of PH WHO Group 1 other than described in inclusion criterion 2 (eg, human immunodeficiency virus (HIV), complex congenital heart disease-associated PAH, portal hypertension-associated PAH, pulmonary veno-occlusive disease, Schistosomiasis associated PAH).
Clinically significant left heart disease, including left-sided valvular disease, left ventricular systolic or diastolic dysfunction, echocardiographic findings suggestive of post-capillary pulmonary hypertension, unstable ischemic heart disease, or unstable arrhythmias.
Evidence of airflow obstruction defined by forced expiratory volume in 1 second (FEV1) per forced vital capacity (FVC) \<0.7.
Evidence of significant restrictive lung disease as evidenced by FVC \<70% predicted normal.
Evidence of chronic thromboembolic disease or recent (within 6 months of Screening) acute pulmonary embolism.
Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (e.g., mannitol, leucine).
Any other medical or psychological condition including relevant laboratory abnormalities at Screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease and/or may present an unreasonable risk to the study participant as a result of his/her participation in this clinical trial, may impede their ability complete the study or the study assessments or confound the outcomes of the trial.

What this trial measures

  • Change in 6-Minute Walk Distance (6MWD) Measured at 1 to 3 Hours Post-Dose From Baseline at Week 24Baseline, Week 24