Pulmonary Arterial HypertensionPhase 2NCT05147805
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension
A Phase 2 study testing Treprostinil Palmitil in people with Pulmonary Arterial Hypertension, run by Insmed Incorporated at 92 sites in 17 countries.
Trial summary
The main objective of the study is to assess the effect of treprostinil palmitil inhalation powder (TPIP) compared with placebo on pulmonary vascular resistance. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 92 sitesin 17 countries
- Study dates
- 24 Aug 2022to 27 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 be ≥ 18 to ≤ 75 years at the time of signing the informed consent form (ICF).
- Participants must have a diagnosis of World Health Organization (WHO) Group 1 Pulmonary Hypertension (PH) [pulmonary arterial hypertension (PAH)] in any of the following subtypes:
- Idiopathic
- Heritable
- Drug/toxin-induced or connective tissue disease (CTD)-associated PAH
- Congenital heart disease-related with simple systemic-to-pulmonary shunt at least 1 year following repair.
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- PAH diagnosis for at least 3 months.
- Participants must be on stable PH therapy consisting of up to 2 medications from the following classes:
- Endothelin receptor antagonists (eg, ambrisentan, bosentan, macitentan)
- Phosphoesterase type 5 inhibitors (eg, sildenafil, tadalafil)
- Guanylate cyclase stimulator (eg, riociguat)
- No change in PH medications (eg, ambrisentan, bosentan, macitentan, sildenafil, tadalafil, riociguat) or dosage for at least 30 days prior to Screening.
- No change in long-term diuretic use or dosage for at least 30 days prior to Screening.
- Body Mass Index (BMI) within the range 18.0-37.0 kg/m^2 (inclusive).
- Male participants: Male participants who are not sterile and have female partners of childbearing potential, must be using effective contraception from Day 1 to at least 90 days after the last dose of study drug.
- Female participants: Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, (ie, post-tubal ligation for at least 12 months) or using highly effective contraception methods (ie, methods that alone or in combination achieve <1% unintended pregnancy rates per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose of study drug.
- Male participants with pregnant or non-pregnant woman of childbearing potential partner must use a condom in order to avoid potential exposure to embryo/fetus.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
Who cannot join
- History of PH other than idiopathic, hereditary, drug/toxin-induced, repaired simple congenital heart disease, or CTD-associated PAH (eg, complex, congenital heart disease-associated PAH, portal hypertension-associated PAH, PH belonging to Groups 2 through 5).
- Allergy, or documented hypersensitivity or contraindication, to TPIP or Treprostinil or mannitol (an excipient of the TPIP formulation).
- Any known ventricular or supraventricular tachyarrhythmia except for paroxysmal atrial fibrillation and any symptomatic bradycardia.
- History of heart disease including left ventricular ejection fraction (LVEF) ≤ 40% or clinically significant valvular, constrictive, or symptomatic atherosclerotic heart disease (eg, stable angina, myocardial infarction, etc).
- Participation in a cardio-pulmonary rehabilitation program within 1 month of Screening Visit.
- Evidence of thromboembolic disease as assessed by ventilation-perfusion (VQ) scan, pulmonary angiography, or pulmonary computed tomography (CT) scan.
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- Active liver disease or hepatic dysfunction.
- History of HIV infection.
- Established diagnosis of hepatitis B viral infection, or positive for hepatitis B surface antigen (HBsAg) at the time of Screening.
- Established diagnosis of hepatitis C viral infection at the time of screening.
- Active and current symptomatic coronavirus disease 2019 (COVID-19) or previous severe disease and/or hospitalization due to COVID-19.
- Use of live attenuated vaccines within 30 days of the Screening Visit.
- Participants with Down's Syndrome.
- History of abnormal bleeding or bruising.
- History of solid organ transplantation.
- Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immune compromised status, as judged by the Investigator.
- History of alcohol or drug abuse within 6 months prior to Screening.
- Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements, in particular with 6-minute walk test (eg, angina pectoris, claudication, musculoskeletal disorder, need for walking aids).
- Participants with current or recent (past 30 days) lower respiratory tract infection.
- History of malignancy in the past 5 years, with exception of completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin.
- Change in PH medication (endothelin receptor agonists, phosphoesterase type 5 inhibitors, and guanylate cyclase stimulators or diuretics) between Screening and Baseline.
- Have participated in any other interventional clinical studies within 30 days prior to Screening.
- Current use of cigarettes (as defined by Centers for Disease Control and Prevention) or e-cigarettes.
- Participants who currently inhale marijuana (recreational or medical).
- Pregnant or breastfeeding.
- Note: Other inclusion/exclusion criteria may apply.
Trial locations and contacts
92 sites in 17 countries.
92 sites in 17 countries
United States21 sites
USA009
Atlanta, Georgia, 30309
USA006
Chicago, Illinois, 60611
USA001
Chicago, Illinois, 60612
USA016
Dallas, Texas, 75246
USA012
Denison, Texas, 75020
USA008
Gainesville, Florida, 32610
USA018
Houston, Texas, 77030
USA013
Indianapolis, Indiana, 46260
USA014
Iowa City, Iowa, 52242
USA005
Jacksonville, Florida, 32224
USA003
Kansas City, Kansas, 66160
USA102
New York, New York, 10021
USA017
New York, New York, 10032-1559
USA007
Orlando, Florida, 32803
USA025
Phoenix, Arizona, 85006
USA023
Sacramento, California, 95817
USA022
Scottsdale, Arizona, 85258
USA011
Tampa, Florida, 33601
USA021
Tucson, Arizona, 85724
USA002
West Hollywood, California, 90048
USA010
Winter Park, Florida, 32792-3800
Japan9 sites
JPN001
Kagoshima, Kagoshima-ken, 890-8520
JPN007
Kurume-Shi, Hukuoka, 830-0011
JPN009
Nagasaki, Nagasaki, 852-8501
JPN002
Okayama, Okayama-ken, 701-1154
JPN005
Sapporo, Hokkaidô, 060-8543
JPN004
Sapporo, Hokkaidô, 060-8648
JPN008
Shinjuku-Ku, Tokyo, 160-8582
JPN003
Suita-Shi, Ôsaka, 564-8565
JPN006
Tsukuba, Ibaraki, 305-8576
Argentina7 sites
ARG004
Córdoba, X5000DCE
ARG001
Córdoba, X5000FPQ
ARG008
Cuiudad Autónoma de Buenos Aires, C1430EGF
ARG009
Quilmes, Buenos Aires, B1878GEG
ARG002
Rosario, Santa Fe Province, S2013DSR
ARG006
Rosario, Santa Fe Province, S2013KDS
ARG007
San Miguel de Tucumán, Tucumán Province, T4000AXL
Spain7 sites
ESP002
Barcelona, 8025
ESP007
Las Palmas, 35010
ESP008
Madrid, 28046
ESP006
Palma de Mallorca, Balearic Islands, 07010
ESP001
Santander, Cantabria, 39008
ESP003
Seville, 41009
ESP004
Toledo, 45007
Brazil6 sites
BRA003
Belo Horizonte, Minas Gerais, 30130
BRA004
Belo Horizonte, Minas Gerais, 30441-070
BRA002
Blumenau, Santa Catarina, 80440-080
BRA007
Passo Fundo, Rio Grande do Sul, 99010-120
BRA006
Porto Alegre, Rio Grande do Sul, 90035-003
BRA001
São Paulo, 05403-000
Germany6 sites
GER007
Berlin, 12683
GER006
Dresden, Saxony, 01307
GER001
Halle, Saxony-Anhalt, 6120
GER005
Heidelberg, Baden-Wurttemberg, 69126
GER002
Lübeck, Schleswig-Holstein, 23562
GER003
Munich, 80639
Italy6 sites
ITA006
Milan, Lombardy, 20123
ITA005
Monza, Lombardy, 20900
ITA003
Naples, Campania, 80131
ITA001
Palermo, Sicily, 90127
ITA002
Pavia, Lombardy, 27100
ITA004
Roma, 00161
Australia5 sites
AUS003
Adelaide, South Australia, 5000
AUS002
Hobart, Tasmania, 7000
AUS004
Milton, Queensland, 4064
AUS005
New Lambton Heights, New South Wales, 2305
AUS001
Woolloongabba, Queensland, 4102
United Kingdom5 sites
GBR001
Bath, Avon, BA1 3NG
GBR002
Glasgow, Lanarkshire, G81 4HX
GBR006
London, London, City of, W12 0HS
GBR004
London, NW3 2Q
GBR003
Newcastle upon Tyne, Tyne and Wear, NE3 3HD
Malaysia4 sites
MYS005
Alor Star, Kedah, 05460
MYS003
Kajang, Selangor, 43000
MYS002
Kuantan, Pahang, 25200
MYS004
Sungai Buloh, Selangor, 47000
Mexico4 sites
MEX005
Lomas de Guevara, Jalisco, 44657
MEX003
Mexico City, Mexico City, 14080
MEX004
San Luis Potosí City, 78200
MEX001
Sertoma, 64718
Belgium3 sites
BEL003
Anderlecht, Brussels Capital, 1070
BEL002
Leuven, Vlaams Brabant, 3000
BEL001
Liège, 4000
Serbia3 sites
SRB004
Belgrade, Belgrade, 116550
SRB001
Belgrade, 11000
SRB003
Belgrade, 11000
Philippines2 sites
PHL002
Makati City, 1229
PHL001
Quezon City, National Capital Region, 1100
About this study
Official title: A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension
The main objective of the study is to assess the effect of treprostinil palmitil inhalation powder (TPIP) compared with placebo on pulmonary vascular resistance.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Treprostinil Palmitil, Placebo
- Keywords
- Treprostinil Palmitil, 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 PalmitilDrug
Also called INS1009
Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler.
PlaceboDrug
Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler.
| Study group | Role | What they receive |
|---|---|---|
| Treprostinil Palmitil Inhalation Powder | Experimental | Participants will be administered TPIP once per day at a starting dose of 80 micrograms (μg). Participants will be up-titrated to the highest tolerated dose for each individual participant of between 80 μg and 640 μg during the initial 3 weeks of treatment. The overall treatment period will be 16 weeks. Receives: Drug: Treprostinil Palmitil |
| Placebo | Placebo comparator | Participants will be administered a placebo matching TPIP once per day for 16 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Pulmonary Vascular Resistance at Week 16
Measured: Baseline to Week 16
Secondary outcomes (24)
Change from Baseline in 6-Minute Walk Test Distance at Week 5, Week 10 and Week 16
Measured: Baseline and Week 5, Week 10 and Week 16
Percent Change from Baseline in 6-Minute Walk Test Distance at Week 5, Week 10 and Week 16
Measured: Baseline and Week 5, Week 10 and Week 16
Number of Participants Who Experience a Treatment-emergent Adverse Event (AE)
Measured: Day 1 up to Week 20
Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Evaluations
Measured: Baseline to Week 16
Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurements
Measured: Baseline to Week 16
Number of Participants Who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements
Measured: Baseline to Week 16
Number of Participants Who Experience a Clinically Significant Change from Baseline in Physical Examinations
Measured: Baseline to Week 16
Maximum Plasma Concentration (Cmax) of Treprostinil Palmitil
Measured: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Maximum Plasma Concentration (Cmax) of Treprostinil
Measured: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Treprostinil Palmitil
Measured: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Treprostinil
Measured: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-Dose (AUC24) of Treprostinil Palmitil
Measured: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-Dose (AUC24) of Treprostinil
Measured: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to Infinity (AUC∞) of Treprostinil Palmitil
Measured: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to Infinity (AUC∞) of Treprostinil
Measured: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to Last Measurable Concentration (AUClast) of Treprostinil Palmitil
Measured: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to Last Measurable Concentration (AUClast) of Treprostinil
Measured: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Apparent Total Clearance (CL/F) of Treprostinil Palmitil
Measured: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Apparent Total Clearance (CL/F) of Treprostinil
Measured: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Apparent Volume of Distribution After Non-Intravenous Administration (Vd/F) of Treprostinil Palmitil
Measured: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Apparent Volume of Distribution After Non-Intravenous Administration (Vd/F) of Treprostinil
Measured: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Elimination Half-Life (t1/2) of Treprostinil Palmitil
Measured: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Elimination Half-Life (t1/2) of Treprostinil
Measured: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Change from Baseline in the Concentration of N-Terminal-Pro Hormone Brain Natriuretic Peptide (NT-proBNP) Levels at Week 5, Week 10 and Week 16
Measured: Baseline and Week 5, Week 10 and Week 16 or end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start24 Aug 2022
- Primary completion27 Mar 2025
- Study completion27 Mar 2025
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147805
- Sponsor's protocol ID
- INS1009-202
- Other IDs
- 2021-001528-16, 2023-505541-99-00, 2023
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2021
- Last updated
- 30 Mar 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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT05147805
- Acronym / sponsor ID
- INS1009-202
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Treprostinil Palmitil, Pulmonary Arterial Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 7 Dec 2021 (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 main objective of the study is to assess the effect of treprostinil palmitil inhalation powder (TPIP) compared with placebo on pulmonary vascular resistance.
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 PalmitilParticipants will be administered TPIP once per day at a starting dose of 80 micrograms (μg). Participants will be up-titrated to the highest tolerated dose for each individual participant of between 80 μg and 640 μg during the initial 3 weeks of treatment. The overall treatment period will be 16 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be administered a placebo matching TPIP once per day for 16 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Participants must be ≥ 18 to ≤ 75 years at the time of signing the informed consent form (ICF).
- Participants must have a diagnosis of World Health Organization (WHO) Group 1 Pulmonary Hypertension (PH) [pulmonary arterial hypertension (PAH)] in any of the following subtypes:
- PAH diagnosis for at least 3 months.
- Participants must be on stable PH therapy consisting of up to 2 medications from the following classes:
- No change in PH medications (eg, ambrisentan, bosentan, macitentan, sildenafil, tadalafil, riociguat) or dosage for at least 30 days prior to Screening.
Key exclusion criteria (26 listed)
- History of PH other than idiopathic, hereditary, drug/toxin-induced, repaired simple congenital heart disease, or CTD-associated PAH (eg, complex, congenital heart disease-associated PAH, portal hypertension-associated PAH, PH belonging to Groups 2 through 5).
- Allergy, or documented hypersensitivity or contraindication, to TPIP or Treprostinil or mannitol (an excipient of the TPIP formulation).
- Any known ventricular or supraventricular tachyarrhythmia except for paroxysmal atrial fibrillation and any symptomatic bradycardia.
- History of heart disease including left ventricular ejection fraction (LVEF) ≤ 40% or clinically significant valvular, constrictive, or symptomatic atherosclerotic heart disease (eg, stable angina, myocardial infarction, etc).
- Participation in a cardio-pulmonary rehabilitation program within 1 month of Screening Visit.
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 PalmitilAlso: INS1009Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler. | Drug | Treprostinil Palmitil Inhalation Powder |
| PlaceboAdministered by oral inhalation using a Plastiape capsule-based dry powder inhaler. | Drug | Placebo |
Primary outcome
Change from Baseline in Pulmonary Vascular Resistance at Week 16
Time frame: Baseline to Week 16
24 secondary outcomes
Change from Baseline in 6-Minute Walk Test Distance at Week 5, Week 10 and Week 16
Time frame: Baseline and Week 5, Week 10 and Week 16
Percent Change from Baseline in 6-Minute Walk Test Distance at Week 5, Week 10 and Week 16
Time frame: Baseline and Week 5, Week 10 and Week 16
Number of Participants Who Experience a Treatment-emergent Adverse Event (AE)
Time frame: Day 1 up to Week 20
Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Evaluations
Time frame: Baseline to Week 16
Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurements
Time frame: Baseline to Week 16
Number of Participants Who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements
Time frame: Baseline to Week 16
Number of Participants Who Experience a Clinically Significant Change from Baseline in Physical Examinations
Time frame: Baseline to Week 16
Maximum Plasma Concentration (Cmax) of Treprostinil Palmitil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Maximum Plasma Concentration (Cmax) of Treprostinil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Treprostinil Palmitil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Treprostinil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-Dose (AUC24) of Treprostinil Palmitil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-Dose (AUC24) of Treprostinil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to Infinity (AUC∞) of Treprostinil Palmitil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to Infinity (AUC∞) of Treprostinil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to Last Measurable Concentration (AUClast) of Treprostinil Palmitil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Area Under the Concentration-time Curve from Time 0 to Last Measurable Concentration (AUClast) of Treprostinil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Apparent Total Clearance (CL/F) of Treprostinil Palmitil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Apparent Total Clearance (CL/F) of Treprostinil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Apparent Volume of Distribution After Non-Intravenous Administration (Vd/F) of Treprostinil Palmitil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Apparent Volume of Distribution After Non-Intravenous Administration (Vd/F) of Treprostinil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Elimination Half-Life (t1/2) of Treprostinil Palmitil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Elimination Half-Life (t1/2) of Treprostinil
Time frame: Day 1, Weeks 2, 3, 5, 10, and 16: Predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Change from Baseline in the Concentration of N-Terminal-Pro Hormone Brain Natriuretic Peptide (NT-proBNP) Levels at Week 5, Week 10 and Week 16
Time frame: Baseline and Week 5, Week 10 and Week 16 or end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
92 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treprostinil Palmitil in people with Pulmonary Arterial Hypertension, run by Insmed Incorporated at 92 sites in 17 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 18 inclusion and 26 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: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 92 sites in United States, Japan, Argentina, Spain, Brazil and 12 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pulmonary Vascular Resistance at Week 16 (time frame: Baseline to Week 16). 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 30 Mar 2026.