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

August 13, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
344

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Córdoba, Argentina, X5000KEH
        • Not yet recruiting
        • ARG004
      • Córdoba, Argentina, X5003DCE
        • Not yet recruiting
        • ARG001
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1060ABN
        • Recruiting
        • ARG005
      • CiudadAutonoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
        • Recruiting
        • ARG002
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, X5800AEV
        • Recruiting
        • ARG003
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
        • Recruiting
        • ARG008
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • AUS001
      • Kingswood, New South Wales, Australia, 2747
        • Recruiting
        • AUS006
      • New Lambton Heights, New South Wales, Australia, 2305
        • Recruiting
        • AUS005
      • Westmead, New South Wales, Australia, 2145
        • Not yet recruiting
        • AUS003
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Not yet recruiting
        • AUS002
  • Austria
      • Innsbruck, Austria, 6020
        • Not yet recruiting
        • AUT002
  • Belgium
      • Anderlecht, Belgium, 1070
        • Recruiting
        • BEL001
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Recruiting
        • BEL002
  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
        • Recruiting
        • BRA012
      • Porto Alegre, Rio Grande do Sul, Brazil, 90560-030
        • Not yet recruiting
        • BRA007
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Not yet recruiting
        • BRA003
  • Czechia
      • Prague, Czechia, 14000
        • Recruiting
        • CZE001
  • Denmark
    • Central Jutland
      • Aarhus N, Central Jutland, Denmark, 8200
        • Recruiting
        • DNK001
  • France
      • Brest, France, 29200
        • Not yet recruiting
        • FRA010
      • Bron, France, 69500
        • Not yet recruiting
        • FRA011
      • Pessac, France, 33604
        • Recruiting
        • FRA005
      • Strasbourg, France, 67091
        • Recruiting
        • FRA006
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 6001
        • Recruiting
        • FRA009
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13015
        • Recruiting
        • FRA002
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49100
        • 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
        • Recruiting
        • FRA001
  • Georgia
      • Tbilisi, Georgia, 0186
        • Recruiting
        • GEO001
      • Tbilisi, Georgia, 0159
        • Recruiting
        • GEO004
      • Tbilisi, Georgia, 0180
        • Recruiting
        • GEO003
      • Tbilisi, Georgia, 0144
        • Recruiting
        • GEO002
  • Germany
      • Gauting, Germany, 82131
        • Recruiting
        • DEU010
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69126
        • Recruiting
        • DEU001
      • Immenhausen, Baden-Wurttemberg, Germany, 34376
        • 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
      • Essen, North Rhine-Westphalia, Germany, 45239
        • Not yet recruiting
        • DEU002
    • Saarland
      • Homburg, Saarland, Germany, 66424
        • Not yet recruiting
        • DEU009
    • Saxony
      • Dresden, Saxony, Germany, 1307
        • Not yet recruiting
        • DEU004
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23562
        • Not yet recruiting
        • DEU011
  • Greece
      • Thessaloniki, Greece, 54636
        • Recruiting
        • GRC001
    • Achaia
      • Pátrai, Achaia, Greece, 26504
        • Not yet recruiting
        • GRC003
    • Anatoliki Attiki
      • Athens, Anatoliki Attiki, Greece, 106 76
        • Recruiting
        • GRC002
    • Crete
      • Heraklion, Crete, Greece, 71500
        • Not yet recruiting
        • GRC004
  • Israel
      • Haifa, Israel, 3436212
        • Recruiting
        • ISR001
      • Haifa, Israel, 3109601
        • Recruiting
        • ISR005
      • 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
      • Monza, Italy, 20900
        • Recruiting
        • ITA005
      • Pavia, Italy, 27100
        • Recruiting
        • ITA001
      • Roma, Italy, 161
        • Not yet recruiting
        • ITA003
      • Rozzano, Italy, 20089
        • Not yet recruiting
        • ITA004
      • Sassari, Italy, 07100
        • Not yet recruiting
        • ITA012
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • 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
        • Recruiting
        • JPN006
      • Seto, Aichi-ken, Japan, 489-8642
        • Not yet recruiting
        • JPN012
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8563
        • Recruiting
        • JPN011
    • Chiba
      • Narashino-shi, Chiba, Japan, 275-0006
        • 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
        • Recruiting
        • JPN010
    • Nagano
      • Matsumoto, Nagano, Japan, 390-8621
        • Not yet recruiting
        • JPN009
      • Nagano, Nagano, Japan, 380-0928
        • Recruiting
        • JPN005
    • Osaka
      • Sakai, Osaka, Japan, 590-0197
        • Recruiting
        • JPN015
      • Suita, Osaka, Japan, 564-8565
        • Recruiting
        • JPN017
    • 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
        • Recruiting
        • JPN003
  • Malaysia
    • Kedah
      • Alor Star, Kedah, Malaysia, 5460
        • Recruiting
        • MYS004
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 15586
        • Not yet recruiting
        • MYS001
    • Pahang
      • Kuantan, Pahang, Malaysia, 25200
        • Recruiting
        • MYS003
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Not yet recruiting
        • MYS002
    • Selangor
      • Kajang, Selangor, Malaysia, 43000
        • Recruiting
        • MYS005
  • New Zealand
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • Recruiting
        • NZL001
    • Otago
      • Dunedin, Otago, New Zealand, 9010
        • Recruiting
        • NZL002
  • Philippines
      • Iloilo City, Philippines, 5000
        • Not yet recruiting
        • PHL002
      • Makati City, Philippines, 1229
        • Not yet recruiting
        • PHL001
  • Portugal
      • Lisbon, Portugal, 1769-001
        • Not yet recruiting
        • PRT001
    • Setúbal District
      • Almada, Setúbal District, Portugal, 2805-267
        • Recruiting
        • PRT002
  • Romania
      • Bucharest, Romania, 11461
        • Not yet recruiting
        • ROU003
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400371
        • Not yet recruiting
        • ROU004
    • Mureș County
      • Târgu Mureş, Mureș County, Romania, 540136
        • Recruiting
        • ROU002
    • Timiș County
      • Timișoara, Timiș County, Romania, 300310
        • Recruiting
        • ROU001
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • SRB001
      • Kamenitz, Serbia, 21102
        • Not yet recruiting
        • SRB002
      • Kragujevac, Serbia, 34000
        • Not yet recruiting
        • SRB003
  • South Korea
      • Incheon, South Korea, 21565
        • Recruiting
        • KOR002
      • Seoul, South Korea, 03080
        • Recruiting
        • KOR001
      • Seoul, South Korea, 6351
        • Recruiting
        • KOR006
      • Seoul, South Korea, 6591
        • Not yet recruiting
        • KOR003
      • Seoul, South Korea, 3722
        • Recruiting
        • KOR004
      • Wŏnju, South Korea, 26426
        • Not yet recruiting
        • KOR005
  • Spain
      • Barcelona, Spain, 8036
        • Recruiting
        • ESP004
      • Barcelona, Spain, 8035
        • Recruiting
        • ESP012
      • Madrid, Spain, 28041
        • Recruiting
        • ESP006
      • Madrid, Spain, 28046
        • Recruiting
        • ESP003
      • Madrid, Spain, 28304
        • Recruiting
        • ESP009
      • Santiago de Compostela, Spain, 15706
        • Not yet recruiting
        • ESP011
      • Seville, Spain, 41009
        • Recruiting
        • ESP001
      • Toledo, Spain, 45007
        • Recruiting
        • ESP007
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 7120
        • Recruiting
        • ESP002
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 8907
        • Recruiting
        • ESP005
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Not yet recruiting
        • ESP010
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • CHE001
      • Zurich, Switzerland, 8091
        • Recruiting
        • CHE002
  • Taiwan
      • Douliu City Yunlin County, Taiwan, 640
        • Not yet recruiting
        • TWN004
      • Hsinchu, Taiwan, 300
        • Recruiting
        • TWN003
      • Kaohsiung City, Taiwan, 80756
        • Recruiting
        • TWN001
      • Taichung, Taiwan, 40447
        • Not yet recruiting
        • TWN005
      • Taipei, Taiwan, 104
        • Not yet recruiting
        • TWN006
      • Taipei, Taiwan, 10002
        • Not yet recruiting
        • TWN002
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 1250
        • Not yet recruiting
        • TUR003
      • Ankara, Turkey (Türkiye), 6010
        • Not yet recruiting
        • TUR004
      • Bursa, Turkey (Türkiye), 16059
        • Not yet recruiting
        • TUR001
      • Eskişehir, Turkey (Türkiye), 26040
        • Not yet recruiting
        • TUR012
      • Kayseri, Turkey (Türkiye), 38039
        • Recruiting
        • TUR005
      • Kocaeli, Turkey (Türkiye), 41380
        • Recruiting
        • TUR009
      • Trabzon, Turkey (Türkiye), 61080
        • Not yet recruiting
        • TUR011
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Not yet recruiting
        • GBR001
      • Glasgow, United Kingdom, G81 4DY
        • Not yet recruiting
        • GBR007
      • 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
        • Recruiting
        • GBR004
  • United States
    • California
      • Los Angeles, California, United States, 900275969
        • Not yet recruiting
        • USA010
      • Santa Barbara, California, United States, 93105-4349
        • Recruiting
        • USA001
    • Florida
      • Gainesville, Florida, United States, 32610
        • Not yet recruiting
        • USA017
      • Naples, Florida, United States, 34102-5412
        • Recruiting
        • USA006
      • St. Petersburg, Florida, United States, 33707-6129
        • Recruiting
        • USA026
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Not yet recruiting
        • USA002
    • New York
      • New York, New York, United States, 10016
        • Not yet recruiting
        • USA005
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Not yet recruiting
        • USA015
    • Oregon
      • Bend, Oregon, United States, 97701
        • Recruiting
        • USA003
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • USA013
    • Virginia
      • Richmond, Virginia, United States, 23230
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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