NCT07285655RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD
A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of L606 (Treprostinil Liposome Inhalation Suspension) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (WHO Group 3)
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 344 (estimated)
- First submitted
- 11 Dec 2025
- Start date
- 23 Apr 2026
- Primary completion date
- Jul 2029
- Lead sponsor
- Liquidia Technologies, Inc.
- NCT number
- NCT07285655
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 344
- From 23 Apr 2026 to the primary completion date, Jul 2029
- 44 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has evidence of clinically significant left-sided heart disease as defined by echocardiography.
- Participants with history of persistent/permanent or uncontrolled atrial fibrillation.
- Has experienced exacerbation of underlying lung disease or active respiratory infection requiring antibiotics.
Other
- PH in the updated WHO Classification Groups 1, 2, 4, or 5.
- Participants with severe obstructive sleep apnea.
- Initiation of pulmonary rehabilitation.
- Note: Other protocol defined inclusion/exclusion criteria may apply.
Who the study is looking for
- 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.
- FEV1/FVC (ratio) \> 0.70.
- 6-minute walk distance ≥ 150 meters
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (44)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| Royal Hobart Hospital Coordinator of this site? Confirm its status | Hobart | Australia | Recruiting |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Peter Lougheed Center Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| Universitaetsklinikum Koeln AöR Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen GmbH Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Universitätsklinikum Giessen und Marburg - Standort Giessen Coordinator of this site? Confirm its status | Giessen | Germany | Recruiting |
| Universitaetsmedizin Greifswald KöR Coordinator of this site? Confirm its status | Greifswald | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Krankenhaus Neuwittelsbach Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| LMU Klinikum Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Le Kremlin-Bicetre | France | Recruiting |
| Royal United Hospitals Bath NHS Foundation Trust Coordinator of this site? Confirm its status | Bath | United Kingdom | Recruiting |
| Royal Free London NHS Foundation Trust Hospital - Royal Free Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Bromptom Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| University Hospitals Plymouth NHS Trust, Derriford Hospital Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Recruiting |
| Sheffield Teaching Hospital NHS Foundation Trust - Royal Hallamshire Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Pauls Stradins Clinical University Hospital Coordinator of this site? Confirm its status | Riga | Latvia | Recruiting |
| Unidade Local De Saude De Almada-Seixal E.P.E. Coordinator of this site? Confirm its status | Almada | Portugal | Recruiting |
| Unidade Local de Saúde de Coimbra, E.P.E. Coordinator of this site? Confirm its status | Coimbra | Portugal | Recruiting |
| Unidade Local De Saude De Santo Antonio E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| University of Colorado Hospital Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Summit Health Coordinator of this site? Confirm its status | Bend | United States | Recruiting |
| Medical University of South Carolina- Nexus Research Clinic Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| National Jewish Hospital Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| St. Vincent Cardiovascular Research Institute Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| David Geffen School of Medicine at UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Dignity Health St Joseph's Hospital and Medical Center Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Arizona Pulmonary Specialists Ltd Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| Tampa General Hospital Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.