Home › Trials › NCT07179380

Once-daily inhaled treprostinil palmitil for pulmonary hypertension linked to interstitial lung disease

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

Phase 3 Interventional Insmed Incorporated · NCT07179380

This trial will test whether once-daily inhaled treprostinil palmitil improves exercise ability over 24 weeks in adults with pulmonary hypertension caused by interstitial lung disease.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment344 (estimated)
Ages18 Years and up
SexAll
SponsorInsmed Incorporated Industry-sponsored
Locations96 sites (Los Angeles, California and 95 other locations)
Trial IDNCT07179380 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial compares once-daily treprostinil palmitil inhalation powder (TPIP) with placebo over 24 weeks in adults who have pulmonary hypertension associated with fibrotic interstitial lung disease. Fibrotic ILD must be confirmed by a centrally read CT and pulmonary hypertension must be confirmed by right heart catheterization with mPAP >20 mmHg, PCWP ≤15 mmHg, and PVR ≥4 WU. Eligible participants must have a 6-minute walk distance between 100 and 500 meters confirmed by two tests at screening performed at least four hours apart. The primary outcome is change in exercise capacity (6MWD) after 24 weeks of once-daily inhaled therapy.

Who should consider this trial

Good fit: Adults with WHO Group 3 pulmonary hypertension due to fibrotic ILD confirmed by central CT and right heart catheterization (mPAP >20 mmHg, PCWP ≤15 mmHg, PVR ≥4 WU) who can walk 100–500 meters on two screening 6MWTs are the intended participants.

Not a fit: Patients without RHC-confirmed PH, with non-fibrotic ILD, significant left heart disease (PCWP >15 mmHg), or unable to complete the required 6MWD range are unlikely to be eligible or to benefit from this trial.

Why it matters

Potential benefit: If successful, the treatment could help people with PH-ILD walk farther and feel less short of breath by delivering prostacyclin activity in an inhaled, once-daily form.

How similar studies have performed: Similar inhaled treprostinil formulations have previously shown benefit in PH-ILD (e.g., the INCREASE trial) though the palmitil prodrug powder formulation is a newer delivery approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

* Diagnosis of PH World Health Organisation (WHO) Group 3 associated with ILD \[including but not limited to idiopathic interstitial pneumonia (IIP), chronic hypersensitivity pneumonitis (HSP), connective tissue disease-associated interstitial lung disease (CTD-ILD), combined pulmonary fibrosis and emphysema (CPFE)\].
* Confirmation of fibrotic interstitial lung disease by centrally overread computed tomography (CT) scan performed at Screening or within prior 12 months.
* PH confirmed by right heart catheterization (RHC) at Screening or within 12 months prior to Screening, with the following hemodynamic findings:

  * Mean pulmonary arterial pressure (mPAP) \>20 millimetre of mercury (mmHg) and
  * Pulmonary capillary wedge pressure (PCWP) of ≤15 mmHg and
  * Pulmonary vascular resistance (PVR) ≥4 wood units (WU).
* 6 Minute walking distance (6MWD) ≥100 and ≤500 meters at two 6MWTs at Screening performed at least 4 hours apart, with the difference between the 2 distances ≤15%.
* Participants receiving chronic medication for underlying disease (e.g., antifibrotic, immunomodulators, immunosuppressants, etc.) and/or phosphodiesterase 5 (PDE5) inhibitors, should be on this treatment for ≥90 days and on a stable dose for ≥30 days prior to Screening.
* Capable of giving signed informed consent as described in Section 10.1.5 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion criteria

* Diagnosis of Pulmonary Hypertension WHO Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease.
* Primary diagnosis of chronic obstructive pulmonary disease (COPD) and/or forced expiratory volume in 1 second (FEV1)/FVC \<0.7 (based on screening or historical spirometry within the prior 6 months).
* Clinically significant left heart disease:

  * evidence of clinically significant left-sided valvular heart disease,
  * left ventricular failure with left ventricular ejection fraction (LVEF) \<45%, or diagnosis of heart failure with preserved ejection fraction (HFpEF)
  * echocardiography findings at Screening suggestive for postcapillary PH
  * unstable ischemic heart disease
  * unstable arrhythmia, including uncontrolled atrial fibrillation (rate-controlled arrhythmia or paroxysmal atrial fibrillation is allowed)
* 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).
* Current use of cigarettes or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime and who currently smokes either every day or some days.
* Current use of inhaled marijuana, recreational or medical (current use defined as used at least one or more times during the past 30 days prior to Screening) or expected use during the study.
* 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.

Note: Other protocol defined inclusion/exclusion criteria may apply.

Where this trial is running

Los Angeles, California and 95 other locations

+46 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary HypertensionInterstitial Lung Diseasepulmonary hypertensioninterstitial lung disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.