Pulmonary Arterial HypertensionPhase 3PALM-PAHNCT07481981
A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)
A Phase 3 study testing Treprostinil Palmitil Inhalation Powder in people with Pulmonary Arterial Hypertension, run by Insmed Incorporated at 39 sites in 8 countries.
Trial summary
The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP compared with placebo on exercise capacity in adults with PAH. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- 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
- 39 sitesin 8 countries
- Study dates
- 21 Jul 2026to 28 Jan 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 21Show fewer
- 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).
Who cannot join
- 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.
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
39 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
39 sites in 8 countries
United States11 sites, 11 recruiting
- Recruiting
USA007
Anderson, South Carolina, 29621
- Recruiting
USA010
Kansas City, Kansas, 66160
- Recruiting
USA012
Los Angeles, California, 90027
- Recruiting
USA022
New Hyde Park, New York, 11042
- Recruiting
USA011
New York, New York, 10016
- Recruiting
USA015
New York, New York, 10075
- Recruiting
USA028
Omaha, Nebraska, 68198-6450
- Recruiting
USA006
Philadelphia, Pennsylvania, 19140
- Recruiting
USA013
Rochester, New York, 14642
- Recruiting
USA008
Santa Barbara, California, 93105
- Recruiting
USA005
Torrance, California, 90502
Japan9 sites, 9 recruiting
- Recruiting
JPN016
Chiba, Chiba, 260-8677
- Recruiting
JPN014
Kobe, Hyōgo, 650-0017
- Recruiting
JPN017
Minato-ku, Tokyo, 108-8329
- Recruiting
JPN004
Mitaka-shi, Tokyo, 181-8611
- Recruiting
JPN011
Narashino, Chiba, 275-8580
- Recruiting
JPN003
Okayama, Okayama-ken, 701-1192
- Recruiting
JPN007
Sapporo, Hokkaido, 060-8543
- Recruiting
JPN002
Sapporo, Hokkaido, 060-8648
- Recruiting
JPN015
Yahatanishi-ku, Kita Kyushu-shi, Fukuoka, 807-8556
Israel5 sites, 5 recruiting
- Recruiting
ISR002
Haifa, 3436212
- Recruiting
ISR001
Jerusalem, 9112001
- Recruiting
ISR004
Petah Tikva, 4941492
- Recruiting
ISR005
Ramat Gan, 5265601
- Recruiting
ISR003
Tel Aviv, 6423906
South Korea5 sites, 5 recruiting
- Recruiting
KOR006
Busan, 49241
- Recruiting
KOR003
Incheon, 21565
- Recruiting
KOR002
Seoul, 03080
- Recruiting
KOR005
Seoul, 03722
- Recruiting
KOR001
Seoul, 06351
Argentina3 sites, 3 recruiting
- Recruiting
ARG001
Buenos Aires, Buenos Aires F.D., C1425AIN
- Recruiting
ARG004
Río Cuarto, Córdoba Province, X5080AEV
- Recruiting
ARG005
San Miguel de Tucumán, Tucumán Province, T4000AXL
New Zealand3 sites, 3 recruiting
- Recruiting
NZL001
Auckland, 2025
- Recruiting
NZL003
Dunedin, 9016
- Recruiting
NZL002
Hamilton, 3240
Australia2 sites, 2 recruiting
- Recruiting
AUS002
Camperdown, New South Wales, 2050
- Recruiting
AUS003
Westmead, New South Wales, 2145
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension
The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP compared with placebo on exercise capacity in adults with PAH.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Treprostinil Palmitil Inhalation Powder, Placebo
- Keywords
- Pulmonary Arterial Hypertension
- Medical subject headings
- Pulmonary Arterial Hypertension
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) up to maximum tolerated dose (up to 1280 μg) for 24 weeks. Receives: Drug: Treprostinil Palmitil Inhalation Powder |
| Placebo | Placebo comparator | Participants will receive a TPIP-matching placebo, 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 1 to 3 Hours Post-Dose From Baseline at Week 24
Measured: Baseline, Week 24
Secondary outcomes (11)
Percentage of Participants With an Improvement From Baseline in World Health Organization (WHO) Functional Class at Week 24
Measured: Baseline, Week 24
Change in 6MWD Measured at 24 Hours (±2) Since the Last Dose From Baseline at Week 22
Measured: Baseline, Week 22
Change From Baseline in the Concentration of N-Terminal Pro Hormone Brain Natriuretic Peptide (NT-proBNP) at Week 24
Measured: Baseline, Week 24
Change From Baseline at Week 24 in Pulmonary Arterial Hypertension-Symptoms and Impact Questionnaire (PAH-SYMPACT) Physical Impacts Domain Score
Measured: Baseline, Week 24
Change From Baseline at Week 24 in PAH-SYMPACT Cardiopulmonary Symptoms Domain Score
Measured: Baseline, Week 24
Time to First Clinical Worsening Event From Baseline Through Week 24
Measured: Baseline up to Week 24
Change in Multiparameter Risk Score From Baseline at the Scheduled Visits Over 24 Weeks (REVEAL Lite 2.0)
Measured: Baseline up to Week 24
Changes From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) per Right Ventricular Systolic Pressure (RVSP) at Week 24
Measured: Baseline, Week 24
Change From Baseline at the Scheduled Visits Over 24 Weeks in PAH-SYMPACT Cardiovascular Symptoms Domain Score
Measured: Baseline up to Week 24
Changes From Baseline at the Scheduled Visits Over 24 Weeks in PAH-SYMPACT Cognitive/Emotional Impacts Domain Score
Measured: Baseline up to Week 24
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 posted19 Mar 2026
- Study start21 Jul 2026
- Primary completion28 Dec 2028 (estimated)
- Study completion28 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481981
- Sponsor's protocol ID
- INS1009-301
- Other IDs
- 2026-525265-48-00
- Acronym
- PALM-PAH
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2026
- Last updated
- 13 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 13 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 Once Daily Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT07481981
- Acronym / sponsor ID
- PALM-PAH / INS1009-301
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary Arterial Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- 28 Dec 2028 (estimated)
- Study completion
- 28 Jan 2029 (estimated)
- First posted
- 19 Mar 2026 (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 compared with placebo on exercise capacity in adults with PAH.
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) up to maximum tolerated dose (up to 1280 μg) for 24 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a TPIP-matching placebo, QD, for 24 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- 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:
- 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:
Key exclusion criteria (8 listed)
- 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.
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 1 to 3 Hours Post-Dose From Baseline at Week 24
Time frame: Baseline, Week 24
11 secondary outcomes
Percentage of Participants With an Improvement From Baseline in World Health Organization (WHO) Functional Class at Week 24
Time frame: Baseline, Week 24
Change in 6MWD Measured at 24 Hours (±2) Since the Last Dose From Baseline at Week 22
Time frame: Baseline, Week 22
Change From Baseline in the Concentration of N-Terminal Pro Hormone Brain Natriuretic Peptide (NT-proBNP) at Week 24
Time frame: Baseline, Week 24
Change From Baseline at Week 24 in Pulmonary Arterial Hypertension-Symptoms and Impact Questionnaire (PAH-SYMPACT) Physical Impacts Domain Score
Time frame: Baseline, Week 24
Change From Baseline at Week 24 in PAH-SYMPACT Cardiopulmonary Symptoms Domain Score
Time frame: Baseline, Week 24
Time to First Clinical Worsening Event From Baseline Through Week 24
Time frame: Baseline up to Week 24
Change in Multiparameter Risk Score From Baseline at the Scheduled Visits Over 24 Weeks (REVEAL Lite 2.0)
Time frame: Baseline up to Week 24
Changes From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) per Right Ventricular Systolic Pressure (RVSP) at Week 24
Time frame: Baseline, Week 24
Change From Baseline at the Scheduled Visits Over 24 Weeks in PAH-SYMPACT Cardiovascular Symptoms Domain Score
Time frame: Baseline up to Week 24
Changes From Baseline at the Scheduled Visits Over 24 Weeks in PAH-SYMPACT Cognitive/Emotional Impacts Domain Score
Time frame: 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
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 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Arterial Hypertension
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
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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.
39 sites in 8 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 Arterial Hypertension, run by Insmed Incorporated at 39 sites in 8 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 21 inclusion and 8 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 13 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 39 sites in United States, Japan, Israel, South Korea, Argentina and 3 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 1 to 3 Hours Post-Dose From Baseline at 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 13 Oct 2026.