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

Conditions

• Pulmonary Hypertension Due to Lung Disease (Disorder)

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• L606 — DRUG
  L606 is a liposomal version of treprostinil intended for delivery via oral inhalation using a study issued nebulizer.
• Placebo — DRUG
  Placebo will match L606 but contain no treprostinil.

Study Details

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.

Key Dates

Start date

Apr 23, 2026

Status verified

Jun 2026

Primary completion

Jul 31, 2029

Completion

Dec 31, 2031

Study Design

Enrollment

344 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: L606 (in combination with nebulizer)
• Placebo Comparator: Placebo (in combination with nebulizer)

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

• Liquidia Point of Contact
  1-888-241-6906
  [email protected]

Locations (3)

Find similar trials in Tampa, FL