Pulmonary HypertensionASCENTNCT06129240
An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH
An observational study of Pulmonary Hypertension and Interstitial Lung Disease, run by Liquidia Technologies, Inc. at 23 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension, Interstitial Lung Disease
- What is being tested?
- LIQ861
- How many people
- 80 participants
- Where
- 23 sitesUnited States
- Study dates
- 28 Dec 2023to 8 Feb 2028
- How long will I take part?
- 52 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject with PH-ILD
Cohort A Key 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.
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
United States23 sites, 8 recruiting
- Active, not recruiting
University of Michigan
Ann Arbor, Michigan, 48109
- Recruiting
Summit Health
Bend, Oregon, 97701
Jeremy Feldman, 541-382-2811, jfeldman@summithealth.com
- Withdrawn
Tufts Medical Center
Boston, Massachusetts, 02111
- Withdrawn
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Rachana Krishna, 843-792-3711, millare@musc.edu
- Active, not recruiting
University of Cincinnati Health
Cincinnati, Ohio, 45219
- Recruiting
National Jewish Health
Denver, Colorado, 80206
Patty George, 303-398-1233, henriksenj@njhealth.org
- Recruiting
The Medical Research Group, Inc.
Fresno, California, 93720
Vijay Balasubramanian, (559) 367-3095, mmoreno@themedicalresearchgroup.com
- Withdrawn
Hartford Hospital
Hartford, Connecticut, 06102
- Active, not recruiting
Houston Methodist
Houston, Texas, 77030
- Recruiting
Vincent Medical Group
Indianapolis, Indiana, 46260
Ashwin Ravichandran, 317-338-8042, ashwin.ravichandran@ascension.org
- Withdrawn
University of California San Diego
La Jolla, California, 92093
- Active, not recruiting
UCLA Westwood
Los Angeles, California, 90095
- Withdrawn
Norton Pulmonary Specialists
Louisville, Kentucky, 40241
- Active, not recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
- Active, not recruiting
NYU Langone Medical Center
New York, New York, 10016
- Recruiting
Advent Health
Orlando, Florida, 32803
James Tarver, 407-303-9984, Tracey.Purvis@AdventHealth.com
- Recruiting
Arizona Pulmonary Specialists
Phoenix, Arizona, 85012
Akshay Muraldihar, 602-271-0832, nidhi@azpulm.com
- Active, not recruiting
University of Rochester
Rochester, New York, 14627
- Active, not recruiting
UC Davis
Sacremento, California, 95817
- Active, not recruiting
University of Utah
Salt Lake City, Utah, 84112
- Active, not recruiting
UCSF
San Francisco, California, 94143
- Recruiting
Tampa General Hospital Center of Research Excellence
Tampa, Florida, 33606
Ricardo Restrepo, 215-964-7399, ricardo@health.usf.edu
About this study
Official title: An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension
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.
Read the detailed description
Open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 \& 3 PH.
Cohort A will include approximately 60 subjects who have WHO Group 3 Pulmonary Hypertension associated with interstitial lung disease (PH-ILD)
Cohort B will include approximately 20 subjects who have WHO Group 3 PH-ILD, have been on protocol specified dosing of inhaled treprostinil QID, not at treatment goal, and able to transition to LIQ861.
The primary objective of this study is to evaluate the safety and tolerability of LIQ861 in subjects with WHO Group 1 \& 3 Pulmonary Hypertension (PH).
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease
- Being tested
- LIQ861
- Medical subject headings
- Hypertension, Pulmonary, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIQ861Drug
trepostinil inhalation powder in combination with inhaler
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | PH-ILD Receives: Drug: LIQ861 | |
| Cohort B | PH-ILD Receives: Drug: LIQ861 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort A: Incident of treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs)
Treatment-emergent AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration. Device-related AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration.
Measured: Baseline until the end of the study.
Cohort B: Number of participants with treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs)
Treatment-emergent AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration. Device-related AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start28 Dec 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion8 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 52 Weeks
Sponsor and investigators
- Lead sponsor
- Liquidia Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129240
- Sponsor's protocol ID
- LTI-401
- Acronym
- ASCENT
- Status last verified
- Jun 2026
- First submitted
- 6 Nov 2023
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT06129240
- Acronym / sponsor ID
- ASCENT / LTI-401
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Liquidia Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 8 Feb 2028 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 \& 3 PH.
Cohort A will include approximately 60 subjects who have WHO Group 3 Pulmonary Hypertension associated with interstitial lung disease (PH-ILD)
Cohort B will include approximately 20 subjects who have WHO Group 3 PH-ILD, have been on protocol specified dosing of inhaled treprostinil QID, not at treatment goal, and able to transition to LIQ861.
The primary objective of this study is to evaluate the safety and tolerability of LIQ861 in subjects with WHO Group 1 \& 3 Pulmonary Hypertension (PH).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 52 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Drug: LIQ861PH-ILD |
| Cohort B | – | Drug: LIQ861PH-ILD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject with PH-ILD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIQ861trepostinil inhalation powder in combination with inhaler | Drug | Cohort A, Cohort B |
Primary outcome
Cohort A: Incident of treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs)
Time frame: Baseline until the end of the study.
Treatment-emergent AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration. Device-related AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration.
Cohort B: Number of participants with treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs)
Time frame: 16 weeks
Treatment-emergent AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration. Device-related AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 4
A Clinical Study of MK-7962 in Chinese Participants With Pulmonary Arterial Hypertension (MK-7962-022)
Hypertension, Pulmonary
Not yet recruiting
Large Language Model Support for CTEPH Differential Diagnosis
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Acute Pulmonary Embolism (PE)
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy
RecruitingPhase 2
A Clinical Trial of NS-863 in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
RecruitingPhase 2
Clinical Trial of NS-863 in Participants With Pulmonary Arterial Hypertension (PAH)
Pulmonary Arterial Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Medical Research Group, Inc.
Fresno, United States
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Interstitial Lung Disease, run by Liquidia Technologies, Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort A: Incident of treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs) (time frame: Baseline until the end of the study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.