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

May 26, 2026 updated by: Insmed Incorporated

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

344

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Córdoba, Argentina, X5000KEH
        • Not yet recruiting
        • ARG004
      • Córdoba, Argentina, X5003DCE
        • Not yet recruiting
        • ARG001
    • Buenos Aires
      • CiudadAutonoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
        • Not yet recruiting
        • ARG002
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, X5800AEV
        • Not yet recruiting
        • ARG003
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
        • Not yet recruiting
        • ARG008
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Not yet recruiting
        • AUS001
      • Kingswood, New South Wales, Australia, 2747
        • Not yet recruiting
        • AUS006
      • New Lambton Heights, New South Wales, Australia, 2305
        • Not yet recruiting
        • AUS005
      • Westmead, New South Wales, Australia, 2145
        • Not yet recruiting
        • AUS003
  • Austria
      • Innsbruck, Austria, 6020
        • Not yet recruiting
        • AUT002
  • Belgium
      • Anderlecht, Belgium, 1070
        • Not yet recruiting
        • BEL001
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Not yet recruiting
        • BEL002
  • Czechia
      • Prague, Czechia, 14000
        • Recruiting
        • CZE001
  • Denmark
    • Central Jutland
      • Aarhus N, Central Jutland, Denmark, 8200
        • Not yet recruiting
        • DNK001
  • France
      • Brest, France, 29200
        • Not yet recruiting
        • FRA010
      • Bron, France, 69500
        • Not yet recruiting
        • FRA011
      • Strasbourg, France, 67091
        • Not yet recruiting
        • FRA006
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 6001
        • Not yet recruiting
        • FRA009
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13015
        • Recruiting
        • FRA002
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49100
        • Not yet recruiting
        • FRA004
    • Nord
      • Lille, Nord, France, 59037
        • Not yet recruiting
        • FRA007
    • Pays de la Loire Region
      • Saint Priest En Jarez, Pays de la Loire Region, France, 42270
        • Not yet recruiting
        • FRA008
    • Val-de-Marne
      • Le Kremlin-Bicêtre, Val-de-Marne, France, 94270
        • Recruiting
        • FRA003
    • Vienne
      • Poitiers, Vienne, France, 86000
        • Not yet recruiting
        • FRA001
  • Georgia
      • Tbilisi, Georgia, 0180
        • Recruiting
        • GEO003
      • Tbilisi, Georgia, 0144
        • Not yet recruiting
        • GEO002
      • Tbilisi, Georgia, 0159
        • Not yet recruiting
        • GEO004
      • Tbilisi, Georgia, 0186
        • Not yet recruiting
        • GEO001
  • Germany
      • Gauting, Germany, 82131
        • Recruiting
        • DEU010
    • Baden-Wurttemberg
      • Immenhausen, Baden-Wurttemberg, Germany, 34376
        • Not yet recruiting
        • DEU005
      • Stuttgart, Baden-Wurttemberg, Germany, 70376
        • Not yet recruiting
        • DEU012
    • Bavaria
      • München, Bavaria, Germany, 80639
        • Recruiting
        • DEU006
      • München, Bavaria, Germany, 80335
        • Not yet recruiting
        • DEU003
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Not yet recruiting
        • DEU008
    • Saarland
      • Homburg, Saarland, Germany, 66424
        • Not yet recruiting
        • DEU009
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23562
        • Not yet recruiting
        • DEU011
  • Greece
    • Achaia
      • Pátrai, Achaia, Greece, 26504
        • Not yet recruiting
        • GRC003
    • Anatoliki Attiki
      • Athens, Anatoliki Attiki, Greece, 106 76
        • Not yet recruiting
        • GRC002
  • Israel
      • Haifa, Israel, 3109601
        • Not yet recruiting
        • ISR005
      • Haifa, Israel, 3436212
        • Not yet recruiting
        • ISR001
      • Tel Aviv, Israel, 6423906
        • Not yet recruiting
        • ISR004
    • Central District
      • Petah Tikva, Central District, Israel, 4941492
        • Not yet recruiting
        • ISR003
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9112001
        • Not yet recruiting
        • ISR002
  • Italy
      • Milan, Italy, 20123
        • Not yet recruiting
        • ITA008
      • Pavia, Italy, 27100
        • Not yet recruiting
        • ITA001
      • Roma, Italy, 161
        • Not yet recruiting
        • ITA003
      • Sassari, Italy, 07100
        • Not yet recruiting
        • ITA012
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Not yet recruiting
        • ITA011
  • Japan
      • Chiba, Japan, 260-8677
        • Not yet recruiting
        • JPN014
      • Tsukuba, Japan, 305-8576
        • Not yet recruiting
        • JPN016
    • Aichi-ken
      • Nagakute, Aichi-ken, Japan, 480-1195
        • Not yet recruiting
        • JPN006
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8563
        • Not yet recruiting
        • JPN011
    • Chiba
      • Narashino-shi, Chiba, Japan, 275-0006
        • Not yet recruiting
        • JPN002
      • Narita-shi, Chiba, Japan, 286-8520
        • Recruiting
        • JPN004
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Not yet recruiting
        • JPN001
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0051
        • Recruiting
        • JPN007
    • Kyoto
      • Kyotoshi, Kyoto, Japan, 606-8507
        • Not yet recruiting
        • JPN010
    • Nagano
      • Nagano, Nagano, Japan, 380-0928
        • Recruiting
        • JPN005
    • Osaka
      • Sakai, Osaka, Japan, 590-0197
        • Not yet recruiting
        • JPN015
    • Tokyo
      • Bunkyo-Ku, Tokyo, Japan, 113-8431
        • Not yet recruiting
        • JPN013
      • Kiyose, Tokyo, Japan, 204-0023
        • Not yet recruiting
        • JPN008
      • Shibuya City, Tokyo, Japan, 151-8528
        • Not yet recruiting
        • JPN003
  • Malaysia
    • Kedah
      • Alor Star, Kedah, Malaysia, 5460
        • Not yet recruiting
        • MYS004
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 15586
        • Not yet recruiting
        • MYS001
    • Pahang
      • Kuantan, Pahang, Malaysia, 25200
        • Not yet recruiting
        • MYS003
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Not yet recruiting
        • MYS002
    • Selangor
      • Kajang, Selangor, Malaysia, 43000
        • Not yet recruiting
        • MYS005
  • New Zealand
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • Not yet recruiting
        • NZL001
    • Otago
      • Dunedin, Otago, New Zealand, 9010
        • Not yet recruiting
        • NZL002
  • Portugal
      • Lisbon, Portugal, 1769-001
        • Not yet recruiting
        • PRT001
    • Setúbal District
      • Almada, Setúbal District, Portugal, 2805-267
        • Not yet recruiting
        • PRT002
  • Romania
    • Mureș County
      • Târgu Mureş, Mureș County, Romania, 540136
        • Not yet recruiting
        • ROU002
    • Timiș County
      • Timișoara, Timiș County, Romania, 300310
        • Not yet recruiting
        • ROU001
  • South Korea
      • Incheon, South Korea, 21565
        • Not yet recruiting
        • KOR002
      • Seoul, South Korea, 3722
        • Not yet recruiting
        • KOR004
      • Seoul, South Korea, 6351
        • Not yet recruiting
        • KOR006
      • Seoul, South Korea, 6591
        • Not yet recruiting
        • KOR003
      • Seoul, South Korea, 03080
        • Not yet recruiting
        • KOR001
      • Wŏnju, South Korea, 26426
        • Not yet recruiting
        • KOR005
  • Spain
      • Barcelona, Spain, 8035
        • Recruiting
        • ESP012
      • Barcelona, Spain, 8036
        • Not yet recruiting
        • ESP004
      • Madrid, Spain, 28041
        • Recruiting
        • ESP006
      • Madrid, Spain, 28046
        • Not yet recruiting
        • ESP003
      • Madrid, Spain, 28304
        • Not yet recruiting
        • ESP009
      • Santiago de Compostela, Spain, 15706
        • Not yet recruiting
        • ESP011
      • Seville, Spain, 41009
        • Not yet recruiting
        • ESP001
      • Toledo, Spain, 45007
        • Not yet recruiting
        • ESP007
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 7120
        • Not yet recruiting
        • ESP002
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 8907
        • Not yet recruiting
        • ESP005
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Not yet recruiting
        • ESP010
  • Switzerland
      • Basel, Switzerland, 4031
        • Not yet recruiting
        • CHE001
      • Zurich, Switzerland, 8091
        • Not yet recruiting
        • CHE002
  • Taiwan
      • Hsinchu, Taiwan, 300
        • Not yet recruiting
        • TWN003
      • Kaohsiung City, Taiwan, 80756
        • Not yet recruiting
        • TWN001
      • Taichung, Taiwan, 40447
        • Not yet recruiting
        • TWN005
      • Taipei, Taiwan, 104
        • Not yet recruiting
        • TWN006
      • Taipei, Taiwan, 10002
        • Not yet recruiting
        • TWN002
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Not yet recruiting
        • GBR002
      • Southampton, United Kingdom, SO16 6YD
        • Not yet recruiting
        • GBR005
    • Greater London
      • London, Greater London, United Kingdom, W12 0HS
        • Not yet recruiting
        • GBR009
    • Yorkshire
      • Sheffield, Yorkshire, United Kingdom, S10 2JF
        • Not yet recruiting
        • GBR004
  • United States
    • California
      • Los Angeles, California, United States, 900275969
        • Not yet recruiting
        • USA010
      • Santa Barbara, California, United States, 93105-4349
        • Not yet recruiting
        • USA001
    • Florida
      • Naples, Florida, United States, 34102-5412
        • Recruiting
        • USA006
      • St. Petersburg, Florida, United States, 33707-6129
        • Not yet recruiting
        • USA026
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Not yet recruiting
        • USA002
    • Oregon
      • Bend, Oregon, United States, 97701
        • Recruiting
        • USA003
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Not yet recruiting
        • USA013
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Not yet recruiting
        • USA008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Treprostinil Palmitil Inhalation Powder
Oral inhalation using a capsule-based dry powder inhaler device.
Other Names:
  • INS1009
Placebo Comparator: Placebo
Participants will receive a placebo matching TPIP QD for 24 weeks.
Drug: Placebo
Oral inhalation using a capsule-based dry powder inhaler device.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Time From Randomization to First Clinical Worsening Over the 24-Week Treatment Period
Time Frame: Up to Week 24
Up to Week 24
Time From Randomization to First Major Morbidity or Mortality Event Over the 24-Week Treatment Period
Time Frame: Up to Week 24
Up to Week 24
Change From Baseline in N-Terminal Pro Hormone Brain Natriuretic Peptide (NT-proBNP) Plasma Concentration Over 24 Weeks
Time Frame: Baseline up to Week 24
Baseline up to Week 24
Number of Participants With Greater Than or Equal to (>=) 30% Decrease in NT-proBNP or Who Maintained/Achieved Less Than (<) 300 Nanogram per Liter (ng/L) of NT-proBNP Level at Week 24
Time Frame: At Week 24
At Week 24
Change in 6MWD Measured at Trough Exposure From Baseline to Week 22
Time Frame: Baseline, Week 22
Baseline, Week 22
Change From Baseline in 6MWD Measured at Peak Exposure Over 20 Weeks
Time Frame: Baseline up to Week 20
Baseline up to Week 20
Mean Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Total Symptom Domain Score Over 24 Weeks
Time Frame: Baseline up to Week 24
Baseline up to Week 24
Plasma Concentrations of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Time Frame: Pre-dose and post-dose at multiple timepoints up to Week 24
Pre-dose and post-dose at multiple timepoints up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insmed Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2026

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

September 10, 2025

First Submitted That Met QC Criteria

September 10, 2025

First Posted (Actual)

September 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INS1009-311
  • 2025-521558-40-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Hypertension

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe