ClinicalTrials.gg
RecruitingNCT07285655Re-SpireUpdated Oct 14, 2026

A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD

A Phase 3 interventional study of L606 and Placebo in Pulmonary Hypertension Due to Lung Disease (Disorder), sponsored by Liquidia Technologies, Inc.. Recruiting at 44 sites in 12 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Liquidia Technologies, Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Updated Oct 14, 2026First site in Canada8 sites addedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
344
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to find out if L606 is safe and if it helps people with high blood pressure in the lungs (pulmonary hypertension) caused by interstitial lung disease (PH-ILD, WHO Group 3). One of the main ways the study will check this is by seeing if people can walk further in six minutes (called the "six-minute walk test"). Another important (secondary) goal is to see how long it takes for PH-ILD to get worse while people are taking L606. One way the study will measure this is by looking at the distance people walk at different times in the study on different doses of L606. Throughout the study, doctors will also closely monitor for any side effects people have to make sure L606 is safe. People who decide to join this study will be randomly (like tossing a coin) placed into one of two groups: one group will get L606 and the other group will get a placebo, which will look like L606 but will not contain any active medicine. At the end of the initial blinded portion of the study, study participants may have the opportunity to enroll in an open-label extension portion of the study where all participants will receive L606.

02

Conditions studied

  • Pulmonary Hypertension Due to Lung Disease (Disorder)

Keywords

  • pulmonary hypertension
  • interstitial lung disease
03

In context

Hypertension, Pulmonary

1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.

This study's planned enrollment of 344 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Liquidia Technologies, Inc. is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant is between 18 years to 80 years old.
  • Has a confirmed diagnosis of ILD based on High Resolution Computed Tomography (HRCT) chest imaging.
  • Evidence of PH as demonstrated from Right Heart Catheterization (RHC) with the following hemodynamic parameters:
  • Pulmonary vascular resistance (PVR) ≥ 320 dynes.sec/cm5 (i.e. 4 Woods Units (WU)), and
  • Mean Pulmonary Artery Pressure (mPAP) of ≥ 25 mmHg, and
  • - Pulmonary capillary wedge pressure (PCWP) or Left-Ventricular End Diastolic Pressure (LVEDP) of ≤ 15 mmHg.
  • /FVC (ratio) > 0.70.
  • 6-minute walk distance ≥ 150 meters

Exclusion criteria

Exclusion Criteria:

  • PH in the updated WHO Classification Groups 1, 2, 4, or 5.
  • Has evidence of left-sided heart disease as defined by echocardiography.
  • Participants with history of persistent/permanent or uncontrolled atrial fibrillation.
  • Participants with severe obstructive sleep apnea.
  • Has experienced exacerbation of underlying lung disease or active respiratory infection requiring antibiotics.
  • Initiation of pulmonary rehabilitation.

Note: Other protocol defined inclusion/exclusion criteria may apply.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
344 participants (estimated)

Study arms

  • Experimental
    L606 (in combination with nebulizer)

    Drug: L606

  • Placebo comparator
    Placebo (in combination with nebulizer)

    Drug: Placebo

Interventions

  • DrugL606

    L606 is a liposomal version of treprostinil intended for delivery via oral inhalation using a study issued nebulizer.

    Also known as: Treprostinil Liposome Inhalation Suspension

  • DrugPlacebo

    Placebo will match L606 but contain no treprostinil.

06

What researchers measure

Primary outcomes

  1. Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)

    Time frame: 16 weeks

Secondary outcomes

  1. Time to first occurrence of: -Death -Hospitalization due to a cardio-pulmonary indication related to underlying disease -Lung transplant -Decrease in 6MWD > 15% from Baseline related to disease under study at 2 consecutive visits >1 week apart

    Time frame: 24 weeks

  2. Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)

    Time frame: 16 weeks

  3. Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)

    Time frame: 24 weeks

07

Study locations

44 of 44 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Jul 2029, 39 months after the start.

Of 31 phase 3 interventional studies under Hypertension, Pulmonary, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 83. This study's planned 39 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2025
First posted
Dec 16, 2025
StartActual
Apr 23, 2026
Primary completionEst.
Jul 2029
CompletionEst.
Dec 2031
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
8 sites added — first site in Canada
Show 8 added (2 Belgium, 1 United States, 1 Canada, 1 France, 1 Germany, 1 Italy, 1 Portugal)
  • Medical University of South Carolina- Nexus Research Clinic · Charleston, United States
  • Hopital Erasme · Anderlecht, Belgium
  • UZ Leuven · Leuven, Belgium
  • Peter Lougheed Center · Calgary, Canada
  • Hospices Civils De Lyon · Bron, France
  • Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen GmbH · Essen, Germany
  • Fondazione IRCCS Policlinico San Matteo · Pavia, Italy
  • Unidade Local De Saude De Coimbra E.P.E. · Coimbra, Portugal
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    8 sites added — first site in Canada
    Show 8 added (2 Belgium, 1 United States, 1 Canada, 1 France, 1 Germany, 1 Italy, 1 Portugal)
    • Medical University of South Carolina- Nexus Research Clinic · Charleston, United States
    • Hopital Erasme · Anderlecht, Belgium
    • UZ Leuven · Leuven, Belgium
    • Peter Lougheed Center · Calgary, Canada
    • Hospices Civils De Lyon · Bron, France
    • Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen GmbH · Essen, Germany
    • Fondazione IRCCS Policlinico San Matteo · Pavia, Italy
    • Unidade Local De Saude De Coimbra E.P.E. · Coimbra, Portugal
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07285655
Lead sponsor
Liquidia Technologies, Inc.
Responsible party
Sponsor
First posted
Dec 16, 2025
Start date
Apr 23, 2026
Primary completion
Jul 2029 (estimated)
Completion
Dec 2031 (estimated)
Last update
Oct 14, 2026

Study contacts

Liquidia Point of Contact
Contact
LiquidiaStudies@liquidia.com
1-888-241-6906

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Treprostinil

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