Pulmonary HypertensionPhase 3PALM-ILDNCT07179380
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
A Phase 3 study testing Treprostinil Palmitil Inhalation Powder in people with Pulmonary Hypertension and Interstitial Lung Disease, run by Insmed Incorporated at 186 sites in 30 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Interstitial Lung Disease
- What is being tested?
- Treprostinil Palmitil Inhalation Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 344 participants
- Where
- 186 sitesin 30 countries
- Study dates
- 7 Jan 2026to 30 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 6 Minute walking distance (6MWD) ≥100 and ≤500 meters at two 6 minute walking test (6MWT)s 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.
Who cannot join
- Diagnosis of Pulmonary Hypertension WHO Groups 1, 2, 4, or 5 (including sarcoidosis), 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)/ forced vital capacity (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%
- echocardiography findings at Screening suggestive for postcapillary (or combined pre and postcapillary) PH, heart failure with preserved ejection fraction (HFpEF), or heart failure with mildly reduced ejection fraction (HFmrEF), including left atrial volume index (LAVI) >34 millilitres per metre square (mL/m^2)
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- 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.
Trial locations and contacts
186 sites in 30 countries. Contact the study team or a site near you to ask about taking part.
186 sites in 30 countries
United States19 sites, 19 recruiting
- Recruiting
USA003
Bend, Oregon, 97701
- Not yet recruiting
USA022
Chapel Hill, North Carolina, 27599
- Recruiting
USA015
Cincinnati, Ohio, 45267
- Recruiting
USA011
Durham, North Carolina, 27710
- Not yet recruiting
USA007
Fresno, California, 93720
- Recruiting
USA017
Gainesville, Florida, 32610
- Recruiting
USA002
Kansas City, Kansas, 66160
- Recruiting
USA010
Los Angeles, California, 900275969
- Recruiting
USA023
Los Angeles, California, 90095
- Recruiting
USA006
Naples, Florida, 34102-5412
- Recruiting
USA005
New York, New York, 10016
- Recruiting
USA013
Philadelphia, Pennsylvania, 19140
- Not yet recruiting
USA027
Phoenix, Arizona, 85013
- Recruiting
USA008
Richmond, Virginia, 23230
- Not yet recruiting
USA025
Salt Lake City, Utah, 84018
- Recruiting
USA020
San Francisco, California, 94143
- Recruiting
USA001
Santa Barbara, California, 93105-4349
- Recruiting
USA026
St. Petersburg, Florida, 33707-6129
- Not yet recruiting
USA028
Tampa, Florida, 33606
Japan17 sites, 17 recruiting
- Recruiting
JPN013
Bunkyo-Ku, Tokyo, 113-8431
- Recruiting
JPN014
Chiba, 260-8677
- Recruiting
JPN011
Hirosaki, Aomori, 036-8563
- Recruiting
JPN008
Kiyose, Tokyo, 204-0023
- Recruiting
JPN010
Kyotoshi, Kyoto, 606-8507
- Recruiting
JPN009
Matsumoto, Nagano, 390-8621
- Recruiting
JPN006
Nagakute, Aichi-ken, 480-1195
- Recruiting
JPN005
Nagano, Nagano, 380-0928
- Recruiting
JPN002
Narashino-shi, Chiba, 275-0006
- Recruiting
JPN004
Narita-shi, Chiba, 286-8520
- Recruiting
JPN015
Sakai, Osaka, 590-0197
- Recruiting
JPN001
Sapporo, Hokkaido, 060-8648
- Recruiting
JPN012
Seto, Aichi-ken, 489-8642
- Recruiting
JPN003
Shibuya City, Tokyo, 151-8528
- Recruiting
JPN017
Suita, Osaka, 564-8565
- Recruiting
JPN016
Tsukuba, 305-8576
- Recruiting
JPN007
Yokohama, Kanagawa, 236-0051
Germany12 sites, 12 recruiting
- Recruiting
DEU008
Bonn, North Rhine-Westphalia, 53127
- Recruiting
DEU004
Dresden, Saxony, 1307
- Recruiting
DEU002
Essen, North Rhine-Westphalia, 45239
- Recruiting
DEU010
Gauting, 82131
- Recruiting
DEU001
Heidelberg, Baden-Wurttemberg, 69126
- Recruiting
DEU009
Homburg, Saarland, 66424
- Recruiting
DEU005
Immenhausen, Baden-Wurttemberg, 34376
- Recruiting
DEU011
Lübeck, Schleswig-Holstein, 23562
- Recruiting
DEU003
München, Bavaria, 80335
- Recruiting
DEU006
München, Bavaria, 80639
- Not yet recruiting
DEU007
München, Bavaria, 81377
- Recruiting
DEU012
Stuttgart, Baden-Wurttemberg, 70376
France11 sites, 11 recruiting
- Recruiting
FRA004
Angers, Maine-et-Loire, 49100
- Recruiting
FRA010
Brest, 29200
- Recruiting
FRA011
Bron, 69500
- Recruiting
FRA003
Le Kremlin-Bicêtre, Val-de-Marne, 94270
- Recruiting
FRA007
Lille, Nord, 59037
- Recruiting
FRA002
Marseille, Bouches-du-Rhône, 13015
- Recruiting
FRA009
Nice, Alpes-Maritimes, 6001
- Recruiting
FRA005
Pessac, 33604
- Recruiting
FRA001
Poitiers, Vienne, 86000
- Recruiting
FRA008
Saint Priest En Jarez, Pays de la Loire Region, 42270
- Recruiting
FRA006
Strasbourg, 67091
Spain11 sites, 11 recruiting
- Recruiting
ESP012
Barcelona, 8035
- Recruiting
ESP004
Barcelona, 8036
- Recruiting
ESP005
L'Hospitalet de Llobregat, Barcelona, 8907
- Recruiting
ESP006
Madrid, 28041
- Recruiting
ESP003
Madrid, 28046
- Recruiting
ESP009
Madrid, 28304
- Recruiting
ESP010
Majadahonda, Madrid, 28222
- Recruiting
ESP002
Palma de Mallorca, Balearic Islands, 7120
- Recruiting
ESP011
Santiago de Compostela, 15706
- Recruiting
ESP001
Seville, 41009
- Recruiting
ESP007
Toledo, 45007
Italy10 sites, 10 recruiting
- Recruiting
ITA011
Bologna, Emilia-Romagna, 40138
- Recruiting
ITA010
Catania, 95123
- Recruiting
ITA008
Milan, 20123
- Not yet recruiting
ITA007
Modena, 41124
- Recruiting
ITA005
Monza, 20900
- Not yet recruiting
ITA013
Naples, 80131
- Recruiting
ITA001
Pavia, 27100
- Recruiting
ITA003
Roma, 161
- Recruiting
ITA004
Rozzano, 20089
- Recruiting
ITA012
Sassari, 07100
United Kingdom9 sites, 9 recruiting
- Recruiting
GBR001
Bath, BA1 3NG
- Recruiting
GBR008
Belfast, BT9 7AB
- Recruiting
GBR007
Glasgow, G81 4DY
- Recruiting
GBR009
London, Greater London, W12 0HS
- Recruiting
GBR002
London, NW3 2QG
- Recruiting
GBR003
London, SW3 6NP
- Recruiting
GBR010
Salford, M6 8HD
- Recruiting
GBR004
Sheffield, Yorkshire, S10 2JF
- Recruiting
GBR005
Southampton, SO16 6YD
Argentina8 sites, 8 recruiting
- Not yet recruiting
ARG010
Ciudad Autónoma de Buenos Aires, Buenos Aires, 01093
- Recruiting
ARG005
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1060ABN
- Recruiting
ARG002
CiudadAutonoma de Buenos Aires, Buenos Aires, C1280AEB
- Recruiting
ARG004
Córdoba, X5000KEH
- Recruiting
ARG001
Córdoba, X5003DCE
- Recruiting
ARG003
Río Cuarto, Córdoba Province, X5800AEV
- Not yet recruiting
ARG011
Rosario, Santa Fe Province, S2002KDS
- Recruiting
ARG008
San Miguel de Tucumán, Tucumán Province, T4000AXL
Brazil8 sites, 8 recruiting
- Recruiting
BRA001
Belo Horizonte, Minas Gerais, 30441-070
- Recruiting
BRA010
Blumenau, Santa Catarina, 89030-101
- Recruiting
BRA012
Porto Alegre, Rio Grande do Sul, 90035-074
- Recruiting
BRA007
Porto Alegre, Rio Grande do Sul, 90560-030
- Recruiting
BRA003
Porto Alegre, Rio Grande do Sul, 90610-000
- Recruiting
BRA005
Ribeirão Preto, São Paulo, 14085-000
- Recruiting
BRA002
São Paulo, 04024-002
- Recruiting
BRA006
São Paulo, 05403-000
Turkey (Türkiye)8 sites, 8 recruiting
- Recruiting
TUR003
Adana, 1250
- Recruiting
TUR004
Ankara, 6010
- Not yet recruiting
TUR008
Ankara, 6560
- Recruiting
TUR001
Bursa, 16059
- Recruiting
TUR012
Eskişehir, 26040
- Recruiting
TUR005
Kayseri, 38039
- Recruiting
TUR009
Kocaeli, 41380
- Recruiting
TUR011
Trabzon, 61080
Australia6 sites, 6 recruiting
- Not yet recruiting
AUS004
Auchenflower, Queensland, 4066
- Recruiting
AUS001
Camperdown, New South Wales, 2050
- Recruiting
AUS006
Kingswood, New South Wales, 2747
- Recruiting
AUS005
New Lambton Heights, New South Wales, 2305
- Recruiting
AUS002
South Brisbane, Queensland, 4101
- Recruiting
AUS003
Westmead, New South Wales, 2145
South Korea6 sites, 6 recruiting
- Recruiting
KOR002
Incheon, 21565
- Recruiting
KOR001
Seoul, 03080
- Recruiting
KOR004
Seoul, 3722
- Recruiting
KOR006
Seoul, 6351
- Recruiting
KOR003
Seoul, 6591
- Recruiting
KOR005
Wŏnju, 26426
Taiwan6 sites, 6 recruiting
- Recruiting
TWN004
Douliu City Yunlin County, 640
- Recruiting
TWN003
Hsinchu, 300
- Recruiting
TWN001
Kaohsiung City, 80756
- Recruiting
TWN005
Taichung, 40447
- Recruiting
TWN002
Taipei, 10002
- Recruiting
TWN006
Taipei, 104
Greece5 sites, 5 recruiting
- Recruiting
GRC002
Athens, Anatoliki Attiki, 106 76
- Recruiting
GRC004
Heraklion, Crete, 71500
- Recruiting
GRC005
Kallithea, Attica, 17674
- Recruiting
GRC003
Pátrai, Achaia, 26504
- Recruiting
GRC001
Thessaloniki, 54636
Israel5 sites, 5 recruiting
- Recruiting
ISR005
Haifa, 3109601
- Recruiting
ISR001
Haifa, 3436212
- Recruiting
ISR002
Jerusalem, Jerusalem, 9112001
- Recruiting
ISR003
Petah Tikva, Central District, 4941492
- Recruiting
ISR004
Tel Aviv, 6423906
Malaysia5 sites, 5 recruiting
- Recruiting
MYS004
Alor Star, Kedah, 5460
- Recruiting
MYS005
Kajang, Selangor, 43000
- Recruiting
MYS001
Kota Bharu, Kelantan, 15586
- Recruiting
MYS003
Kuantan, Pahang, 25200
- Recruiting
MYS002
Kuching, Sarawak, 93586
Colombia4 sites, 4 recruiting
- Not yet recruiting
COL004
Bogotá, Cundinamarca, 111211
- Recruiting
COL003
Bogotá D.C., Bogota D.C., 110131
- Recruiting
COL001
Cali, Valle del Cauca Department, 760042
- Not yet recruiting
COL002
Floridablanca, Santander Department, 681004
Georgia4 sites, 4 recruiting
- Recruiting
GEO002
Tbilisi, 0144
- Recruiting
GEO004
Tbilisi, 0159
- Recruiting
GEO003
Tbilisi, 0180
- Recruiting
GEO001
Tbilisi, 0186
Philippines4 sites, 4 recruiting
- Recruiting
PHL002
Iloilo City, 5000
- Recruiting
PHL001
Makati City, 1229
- Recruiting
PHL003
Manila, 1015
- Recruiting
PHL004
Quezon City, 1100
Poland4 sites, 4 recruiting
- Recruiting
POL002
Bialystok, 15276
- Not yet recruiting
POL006
Krakow, 31-202
- Not yet recruiting
POL004
Lublin, 20-718
- Recruiting
POL001
Warsaw, 02-005
Romania4 sites, 4 recruiting
- Recruiting
ROU003
Bucharest, 11461
- Recruiting
ROU004
Cluj-Napoca, Cluj, 400371
- Recruiting
ROU002
Târgu Mureş, Mureș County, 540136
- Recruiting
ROU001
Timișoara, Timiș County, 300310
Serbia4 sites, 4 recruiting
- Recruiting
SRB001
Belgrade, 11000
- Not yet recruiting
SRB004
Belgrade, 11000
- Recruiting
SRB002
Kamenitz, 21102
- Recruiting
SRB003
Kragujevac, 34000
Austria3 sites, 3 recruiting
- Recruiting
AUT002
Innsbruck, 6020
- Recruiting
AUT001
Linz, 4021
- Recruiting
AUT003
Vienna, 1090
Mexico3 sites, 3 recruiting
- Not yet recruiting
MEX003
Mexico City, 14080
- Not yet recruiting
MEX002
Monterrey, Nuevo León, 64460
- Not yet recruiting
MEX001
Monterrey, Nuevo León, 64718
Belgium2 sites, 2 recruiting
- Recruiting
BEL001
Anderlecht, 1070
- Recruiting
BEL002
Leuven, Vlaams Brabant, 3000
New Zealand2 sites, 2 recruiting
- Recruiting
NZL001
Christchurch, Canterbury, 8011
- Recruiting
NZL002
Dunedin, Otago, 9010
Portugal2 sites, 2 recruiting
- Recruiting
PRT002
Almada, Setúbal District, 2805-267
- Recruiting
PRT001
Lisbon, 1769-001
Switzerland2 sites, 2 recruiting
- Recruiting
CHE001
Basel, 4031
- Recruiting
CHE002
Zurich, 8091
About this study
Official title: 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.
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease
- Being tested
- Treprostinil Palmitil Inhalation Powder, Placebo
- Keywords
- pulmonary hypertension, interstitial lung disease
- Medical subject headings
- Hypertension, Pulmonary, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treprostinil Palmitil Inhalation PowderDrug
Also called INS1009
Oral inhalation using a capsule-based dry powder inhaler device.
PlaceboDrug
Oral inhalation using a capsule-based dry powder inhaler device.
| Study group | Role | What they receive |
|---|---|---|
| Treprostinil Palmitil Inhalation Powder | Experimental | 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. Receives: Drug: Treprostinil Palmitil Inhalation Powder |
| Placebo | Placebo comparator | Participants will receive a placebo matching TPIP QD for 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 Minute Walk Distance (6MWD) Measured at Peak Exposure From Baseline to Week 24
Measured: Baseline, Week 24
Secondary outcomes (8)
Time From Randomization to First Clinical Worsening Over the 24-Week Treatment Period
Measured: Up to Week 24
Time From Randomization to First Major Morbidity or Mortality Event Over the 24-Week Treatment Period
Measured: Up to Week 24
Change From Baseline in N-Terminal Pro Hormone Brain Natriuretic Peptide (NT-proBNP) Plasma Concentration Over 24 Weeks
Measured: 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
Measured: At Week 24
Change in 6MWD Measured at Trough Exposure From Baseline to Week 22
Measured: Baseline, Week 22
Mean Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Total Symptom Domain Score Over 24 Weeks
Measured: Baseline up to Week 24
Number of Participants Who Experienced At-Least One Treatment-Emergent Adverse Event (TEAEs)
Measured: Up to Week 28
Plasma Concentrations of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Measured: Pre-dose and post-dose at multiple timepoints up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start7 Jan 2026
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Insmed Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179380
- Sponsor's protocol ID
- INS1009-311
- Other IDs
- 2025-521558-40-00, jRCT2031250506, 2025
- Acronym
- PALM-ILD
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07179380
- Acronym / sponsor ID
- PALM-ILD / INS1009-311
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease
- Keywords
- pulmonary hypertension, interstitial lung disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treprostinil Palmitil Inhalation Powder | Experimental | Drug: Treprostinil Palmitil Inhalation PowderParticipants 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 | Placebo comparator | Drug: PlaceboParticipants will receive a placebo matching TPIP QD for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 6 Minute walking distance (6MWD) ≥100 and ≤500 meters at two 6 minute walking test (6MWT)s 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.
Key exclusion criteria (14 listed)
- Diagnosis of Pulmonary Hypertension WHO Groups 1, 2, 4, or 5 (including sarcoidosis), 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)/ forced vital capacity (FVC) <0.7 (based on screening or historical spirometry within the prior 6 months).
- Clinically significant left heart disease:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treprostinil Palmitil Inhalation PowderAlso: INS1009Oral inhalation using a capsule-based dry powder inhaler device. | Drug | Treprostinil Palmitil Inhalation Powder |
| PlaceboOral inhalation using a capsule-based dry powder inhaler device. | Drug | Placebo |
Primary outcome
Change in 6 Minute Walk Distance (6MWD) Measured at Peak Exposure From Baseline to Week 24
Time frame: Baseline, Week 24
8 secondary outcomes
Time From Randomization to First Clinical Worsening Over the 24-Week Treatment Period
Time frame: 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
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
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
Change in 6MWD Measured at Trough Exposure From Baseline to Week 22
Time frame: Baseline, Week 22
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
Number of Participants Who Experienced At-Least One Treatment-Emergent Adverse Event (TEAEs)
Time frame: Up to Week 28
Plasma Concentrations of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Time frame: Pre-dose and post-dose at multiple timepoints up to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Insmed Incorporated
186 sites in 30 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Treprostinil Palmitil Inhalation Powder in people with Pulmonary Hypertension and Interstitial Lung Disease, run by Insmed Incorporated at 186 sites in 30 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 186 sites in United States, Japan, Germany, France, Spain and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Insmed Medical Information (18444467633, medicalinformation@insmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6 Minute Walk Distance (6MWD) Measured at Peak Exposure From Baseline to Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.