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

NCT07285655 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: L606-301
• Study Type: interventional
• Target: 344
• Locations: 0 countries
• Sites: N/A

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)

Keywords

pulmonary hypertension; interstitial lung disease

Outcome Measures

Primary Outcomes (1)

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

  16 weeks

Secondary Outcomes (3)

• 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

  24 weeks

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

  16 weeks

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

  24 weeks

Study Arms (2)

L606 (in combination with nebulizer)

EXPERIMENTAL

Drug: L606

Placebo (in combination with nebulizer)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

L606 DRUG

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

L606 (in combination with nebulizer)

Placebo DRUG

Placebo will match L606 but contain no treprostinil.

Placebo (in combination with nebulizer)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• EV1/FVC (ratio) \> 0.70.
• minute walk distance ≥ 150 meters

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liquidia Technologies, Inc.: lead

MeSH Terms

Conditions

Hypertension, Pulmonary; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Liquidia Point of Contact

CONTACT

1-888-241-6906; LiquidiaStudies@liquidia.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 16, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): December 1, 2031
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share