NCT06129240 · Liquidia Technologies, Inc.
An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH
(ASCENT)
What this study is about
Study LTI-401 is an where both patients and doctors know the treatment given, conducted at multiple hospitals study which will evaluate the safety and how well patients handle the treatment of LIQ861 in subjects who have WHO Group 1 \& 3 PH.
View original scientific description
Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 \& 3 PH.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Males or Females between 18 years to 80 years of age.
- 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.
- 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
- 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.
- 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:
- PH in the Updated WHO Classification Groups 1, 2, 4, or 5.
- History of hemodynamically significant left-sided heart disease.
- Exacerbation of underlying lung disease or active pulmonary or upper respiratory infections.
- Initiation of pulmonary rehabilitation. Cohort B Key Inclusion Criteria
- Male or Females between 18 years to 75 years of age at Screening.
- 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:
- Pulmonary vascular resistance (PVR) ≥3 Wood Units (WU) and
- Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and
- A mean pulmonary arterial pressure (mPAP) of ≥ 25 mmHg
- 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.
- 6-minute walk distance of ≥ 200 meters Cohort B Key Exclusion Criteria
- PH in the Updated WHO Classification Groups 1, 2, 4, or 5.
- Inability to titrate inhaled treprostinil above 5 breaths (Tyvaso®) or above 16 mcg Tyvaso DPI®.
- History of Bronchospasm with Tyvaso or Tyvaso DPI.
- History of persistent moderate asthma or severe asthma.
- History of hemodynamically significant left-sided heart disease.
- Exacerbation of underlying lung disease or active pulmonary or upper respiratory infections.
Where
- Phoenix, Arizona
- Fresno, California
- La Jolla, California
- Los Angeles, California
- Sacremento, California
- San Francisco, California
- Denver, Colorado
- Hartford, Connecticut
- Orlando, Florida
- Tampa, Florida
- Indianapolis, Indiana
- Louisville, Kentucky
And 11 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations