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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

Full criteria on ClinicalTrials.gov

Sites (44)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ordensklinikum Linz GmbH
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LinzAustriaRecruiting
Royal Hobart Hospital
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HobartAustraliaRecruiting
Hopital Erasme
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AnderlechtBelgiumRecruiting
Universitair Ziekenhuis Gent
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GhentBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Peter Lougheed Center
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CalgaryCanadaRecruiting
Universitaetsklinikum Koeln AöR
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CologneGermanyRecruiting
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen GmbH
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EssenGermanyRecruiting
Universitätsklinikum Giessen und Marburg - Standort Giessen
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GiessenGermanyRecruiting
Universitaetsmedizin Greifswald KöR
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GreifswaldGermanyRecruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyRecruiting
Medizinische Hochschule Hannover
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HanoverGermanyRecruiting
Krankenhaus Neuwittelsbach
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MunichGermanyRecruiting
LMU Klinikum Muenchen AöR
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MunichGermanyRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
Hospices Civils de Lyon
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BronFranceRecruiting
Assistance Publique Hopitaux De Paris
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Le Kremlin-BicetreFranceRecruiting
Royal United Hospitals Bath NHS Foundation Trust
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BathUnited KingdomRecruiting
Royal Free London NHS Foundation Trust Hospital - Royal Free Hospital
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LondonUnited KingdomRecruiting
Royal Bromptom Hospital
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LondonUnited KingdomRecruiting
University Hospitals Plymouth NHS Trust, Derriford Hospital
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PlymouthUnited KingdomRecruiting
Sheffield Teaching Hospital NHS Foundation Trust - Royal Hallamshire Hospital
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SheffieldUnited KingdomRecruiting
IRCCS Ospedale Policlinico San Martino
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GenoaItalyRecruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyRecruiting
Pauls Stradins Clinical University Hospital
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RigaLatviaRecruiting
Unidade Local De Saude De Almada-Seixal E.P.E.
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AlmadaPortugalRecruiting
Unidade Local de Saúde de Coimbra, E.P.E.
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CoimbraPortugalRecruiting
Unidade Local De Saude De Santo Antonio E.P.E.
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PortoPortugalRecruiting
University of Colorado Hospital
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AuroraUnited StatesRecruiting
Summit Health
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BendUnited StatesRecruiting
Medical University of South Carolina- Nexus Research Clinic
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CharlestonUnited StatesRecruiting
Northwestern University
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ChicagoUnited StatesRecruiting
National Jewish Hospital
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DenverUnited StatesRecruiting
St. Vincent Cardiovascular Research Institute
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IndianapolisUnited StatesRecruiting
David Geffen School of Medicine at UCLA
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Los AngelesUnited StatesRecruiting
NYU Langone Health
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New YorkUnited StatesRecruiting
Dignity Health St Joseph's Hospital and Medical Center
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PhoenixUnited StatesRecruiting
University of Rochester Medical Center
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RochesterUnited StatesRecruiting
University of California San Francisco
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San FranciscoUnited StatesRecruiting
Arizona Pulmonary Specialists Ltd
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ScottsdaleUnited StatesRecruiting
Tampa General Hospital
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TampaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.