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New inhaled powder for lung blood pressure condition tested in 80 patients

NCT ID NCT06129240

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing the safety of an inhaled dry powder form of treprostinil (LIQ861) for people with pulmonary hypertension (high blood pressure in the lungs) due to lung disease. About 80 adults will take the drug using a special inhaler, and researchers will monitor for side effects. The goal is to see if this new way of delivering the medicine is safe and tolerable.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
treprostinil inhalation powder (LIQ861)
What this could lead to
If it works, this could provide a more convenient, dry-powder inhaled option to help control pulmonary hypertension.
What could go wrong
This is an early safety study with only 80 participants, so it may not prove effectiveness. Side effects from treprostinil can include headache, nausea, and jaw pain.
Why investors are watching

Liquidia is testing LIQ861, an inhaled dry powder version of treprostinil, in 80 patients with pulmonary hypertension. For a small company, this safety and tolerability readout matters because it could support a broader use of their drug beyond the current approved setting.

If it works: A positive safety result could strengthen Liquidia's position in the pulmonary hypertension market and support future regulatory filings. It may also open the door to treating more patient groups, which would expand the drug's potential reach.

If it fails: The trial could fail to show acceptable safety or tolerability, which would set back the drug's development. Trials often fail, and a negative result could hurt the company's prospects and delay any commercial progress.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subject with PH-ILD

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Cohort A Key Inclusion Criteria: 1. Males or Females between 18 years to 80 years of age. 2. Has a confirmed diagnosis of WHO Group 3 PH-ILD based on CT chest imaging performed, which demonstrates evidence of diffuse parenchymal lung disease and FEV1/FVC (absolute values) ≥ 70% and are required to have evidence of pulmonary hypertension (PH) as demonstrated from right heart catheterization (RHC) with the following hemodynamic parameters. 1. i) Pulmonary vascular resistance (PVR) ≥ 3 Wood Units (WU) and ii) Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and iii) A mean pulmonary arterial pressure (mPAP) of ≥ 30 mmHg. OR 2. An exploratory subset of subjects with ILD: i) Pulmonary vascular resistance (PVR) ≥ 3 Wood Units (WU) and ii) Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and iii) A mean pulmonary arterial pressure (mPAP) of ≥ 21 mmHg. 3. 6-minute walk distance of ≥ 125 meters Cohort A Key Exclusion Criteria: A Subject is not eligible for inclusion in the study if any of the following criteria apply: 1. PH in the Updated WHO Classification Groups 1, 2, 4, or 5. 2. History of hemodynamically significant left-sided heart disease. 3. Exacerbation of underlying lung disease or active pulmonary or upper respiratory infections. 4. Initiation of pulmonary rehabilitation. Cohort B Key Inclusion Criteria 1. Male or Females between 18 years to 75 years of age at Screening. 2. Has a diagnosis of WHO Group 3 PH-ILD confirmed with CT chest imaging performed at the screening visit, which demonstrates evidence of diffuse parenchymal lung disease and FEV1/FVC (absolute values) ≥70%. Subjects are required to have evidence of pulmonary hypertension (PH) as demonstrated from right heart catheterization (RHC) with the following documented parameters: 1. Pulmonary vascular resistance (PVR) ≥3 Wood Units (WU) and 2. Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and 3. A mean pulmonary arterial pressure (mPAP) of ≥ 25 mmHg 3. Subjects must be on protocol specified dose of inhaled treprostinil QID not at treatment goal, and able to transition from their prescribed dose of inhaled Treprostinil therapy to LIQ861. 4. 6-minute walk distance of ≥ 200 meters Cohort B Key Exclusion Criteria 1. PH in the Updated WHO Classification Groups 1, 2, 4, or 5. 2. Inability to titrate inhaled treprostinil above 5 breaths (Tyvaso®) or above 16 mcg Tyvaso DPI®. 3. History of Bronchospasm with Tyvaso or Tyvaso DPI. 4. History of persistent moderate asthma or severe asthma. 5. History of hemodynamically significant left-sided heart disease. 6. Exacerbation of underlying lung disease or active pulmonary or upper respiratory infections.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advent Health

    RECRUITING

    Orlando, Florida, 32803, United States

  • Arizona Pulmonary Specialists

    RECRUITING

    Phoenix, Arizona, 85012, United States

  • Hartford Hospital

    WITHDRAWN

    Hartford, Connecticut, 06102, United States

  • Houston Methodist

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77030, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • NYU Langone Medical Center

    ACTIVE_NOT_RECRUITING

    New York, New York, 10016, United States

  • National Jewish Health

    RECRUITING

    Denver, Colorado, 80206, United States

  • Norton Pulmonary Specialists

    WITHDRAWN

    Louisville, Kentucky, 40241, United States

  • Summit Health

    RECRUITING

    Bend, Oregon, 97701, United States

  • Tampa General Hospital Center of Research Excellence

    RECRUITING

    Tampa, Florida, 33606, United States

  • The Medical Research Group, Inc.

    RECRUITING

    Fresno, California, 93720, United States

  • Tufts Medical Center

    WITHDRAWN

    Boston, Massachusetts, 02111, United States

  • UC Davis

    ACTIVE_NOT_RECRUITING

    Sacremento, California, 95817, United States

  • UCLA Westwood

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90095, United States

  • UCSF

    ACTIVE_NOT_RECRUITING

    San Francisco, California, 94143, United States

  • University of California San Diego

    WITHDRAWN

    La Jolla, California, 92093, United States

  • University of Cincinnati Health

    ACTIVE_NOT_RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Michigan

    ACTIVE_NOT_RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    ACTIVE_NOT_RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of North Carolina at Chapel Hill

    WITHDRAWN

    Chapel Hill, North Carolina, 27514, United States

  • University of Rochester

    ACTIVE_NOT_RECRUITING

    Rochester, New York, 14627, United States

  • University of Utah

    ACTIVE_NOT_RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Vincent Medical Group

    RECRUITING

    Indianapolis, Indiana, 46260, United States

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