Recruiting
Phase 3

L606

Sponsor:

Liquidia Technologies, Inc.

Code:

NCT07285655

Conditions

Pulmonary Hypertension Due to Lung Disease (Disorder)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

L606

Placebo

Study Details

Brief 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.

Conditions

Pulmonary Hypertension Due to Lung Disease (Disorder)

Study ID

NCT07285655

Start date

Apr 23, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.
  • FEV1/FVC (ratio) > 0.70.
  • 6-minute walk distance ≥ 150 meters

Exclusion Criteria:

  • PH in the updated WHO Classification Groups 1, 2, 4, or 5.
  • Has evidence of clinically significant 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.

Study Design

Enrollment

344 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: L606 (in combination with nebulizer)

placebo comparator: Placebo (in combination with nebulizer)

Interventions

L606

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

Placebo

Placebo will match L606 but contain no treprostinil.

Primary outcome measure

  • Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT) [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Locations

Dignity Health - St. Joseph's Hospital and Medical Center

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Arizona Pulmonary Specialists, Ltd.

Recruiting

Scottsdale, Arizona, United States, 85258

David Geffen School of Medicine at UCLA

Recruiting

Los Angeles, California, United States, 90095-1690

Contacts

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

National Jewish Hospital

Recruiting

Denver, Colorado, United States, 80206

Contacts

Skyler Chenaille

chenailles@njhealth.org

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Elisabeth Ballans

eballans@tgh.org

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

St. Vincent Cardiovascular Research Institute

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Summit Health

Recruiting

Bend, Oregon, United States, 97701

Contacts

More Information

Sponsor

Liquidia Technologies, Inc.

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • pulmonary hypertension
  • interstitial lung disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Liquidia Technologies, Inc. on 2026-09-02.