Phase 3 Study of L606 for Pulmonary Hypertension Due to Lung Disease (PH-ILD)

This study is testing L606, an inhaled medication, to see if it is safe and effective for people with high blood pressure in the lungs (pulmonary hypertension) caused by interstitial lung disease (PH-ILD). You might be able to join if you are 18 to 80 years old and have a confirmed diagnosis of PH-ILD. The study will measure success by seeing if participants can walk further in six minutes and how long it takes for their PH-ILD to worsen. Researchers will also carefully monitor for any side effects. This study is currently recruiting about 344 participants.

Study design
This is a Phase 3 interventional study comparing L606 to a placebo (an inactive substance). It plans to enroll 344 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 16 weeks, suggesting follow-up for at least this duration.

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NCT07285655

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

Recruiting
PHASE3Ages 18–80InterventionalTreatment
Liquidia Technologies, Inc.
~344 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:L606Placebo

At a glance

Recruiting sites
16 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)
Measured over 16 weeks
Pulmonary Hypertension Due to Lung Disease (Disorder)
16 sites across 13 states
Germany3
United Kingdom2
Arizona1
Florida1
Illinois1
Indiana1
Oregon1
Austria1

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Eligibility criteria

Inclusion

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

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.
  • Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT)16 weeks