LIQ861 for Pulmonary Hypertension

(ASCENT Trial)

Recruiting at 22 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Liquidia Technologies, Inc.

Must be taking: PDE5-I

Must not be taking: Prostacyclins, ERAs, sGCs

Disqualifiers: Hypertension, Heart disease, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 52 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new dry powder inhaler called LIQ861 for individuals with certain types of pulmonary hypertension (PH) and lung disease. It targets those with PH related to lung issues, confirmed by specific tests and imaging, who can walk a certain distance. Participants should not have severe heart disease or have recently changed their lung treatments. Individuals with stable lung disease, treated with consistent medication, and who can walk about two city blocks might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important advancements in PH treatment.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of any chronic medication for your lung disease for at least 30 days before starting and throughout the study. Some medications for pulmonary hypertension must not be started or changed within 30 days before the trial.

Is there any evidence suggesting that LIQ861 is likely to be safe for humans?

Research has shown that LIQ861, an inhaled dry powder medication, has promising safety results. Studies have found that it improves heart function in patients with pulmonary hypertension linked to interstitial lung disease (PH-ILD). This suggests the treatment is effective without causing major issues.

Regarding safety, patients who previously used inhaled treprostinil have generally tolerated it well, with no major reports of serious side effects. This is encouraging for those considering joining a trial. However, experiences can vary, so discussing participation with a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for pulmonary hypertension (PH) associated with interstitial lung disease (ILD), which often involve oral or injectable medications, dry powder inhaled treprostinil offers a unique approach. This treatment is administered through inhalation, allowing the medication to act directly on the lungs, potentially leading to faster and more targeted relief. Researchers are excited because this delivery method could improve patient adherence and comfort, reducing the systemic side effects commonly associated with other forms of treprostinil. Additionally, inhaled treprostinil may provide more consistent control of symptoms by directly targeting the affected area with each dose.

What evidence suggests that LIQ861 might be an effective treatment for PH?

Research shows that inhaled treprostinil, the main ingredient in LIQ861, helps the heart function better in people with pulmonary hypertension and interstitial lung disease (PH-ILD). Studies have found that this treatment reduces heart strain, enhancing its function in these patients. Liquidia Corporation has shared data indicating that LIQ861 is safe and may effectively treat pulmonary hypertension. Early results are promising, showing potential benefits for people with PH-ILD. Overall, the treatment aims to improve heart function and breathing for those with this condition. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

You need to be able to walk more than 125 meters in two six-minute walk tests (6MWTs). The difference in distance between the two tests should be within 15% of each other.

You need to sign a form saying you understand and agree to be part of the study before you can start.

If you are a woman who could become pregnant, you need to have a negative pregnancy test and use birth control during the study. If you are postmenopausal or have had surgery to prevent pregnancy, you don't need a pregnancy test or birth control. The doctor will decide if your birth control is enough for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Initial assessments and baseline measurements before treatment begins

1 week

1 visit (in-person)

Treatment

Participants receive LIQ861 with dose titration as needed, evaluated for safety and tolerability

52 weeks

Visits at Week 8, Week 16, Week 24, and Week 52 (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LIQ861

How Is the Trial Designed?

Group I: Cohort A Experimental Treatment 1 Intervention

PH-ILD

Who Is Running the Clinical Trial?

Liquidia Technologies, Inc.

Lead Sponsor

Trials

7

Recruited

500+

Citations

1.

liquidia.com

liquidia.com/news-releases/news-release-details/liquidia-present-clinical-data-ascent-trial-chest-2025-annual

Liquidia to Present Clinical Data from ASCENT Trial at the ...

The company's two presentations will focus on new data from its ASCENT trial pertaining to both the safety and exploratory efficacy of LIQ861 ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06129240

Study Details | NCT06129240 | An Open-Label ...

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). The ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12182618/

Therapeutic options for patients with pulmonary hypertension ...

In this review, we focus on therapeutic options for patients with pulmonary hypertension and interstitial lung disease (PH-ILD).

4.

respiratory-therapy.com

respiratory-therapy.com/disorders-diseases/cardiopulmonary-thoracic/pulmonary-hypertension/inhaled-treprostinil-cardiac-effort-ph-ild/

Inhaled Treprostinil Improves Cardiac Effort in PH-ILD Patients

Treatment with an inhaled dry powder formulation of treprostinil was associated with improvements in cardiac effort for PH-ILD patients.

5.

quiverquant.com

quiverquant.com/news/Liquidia+Corporation+to+Present+New+Data+on+LIQ861+at+Pulmonary+Hypertension+Professional+Association+Symposium

Liquidia Corporation to Present New Data on LIQ861 at ...

The company will showcase new safety and exploratory efficacy data from the ASCENT study focusing on patients with pulmonary hypertension ...

6.

liquidia.com

liquidia.com/static-files/a99f0e66-c8aa-49fe-9f9b-ff54b29b78ad

ASCENT TO WEEK 16

... PH-ILD = pulmonary hypertension associated with interstitial lung disease. Reference: LTI-401 Protocol, p.20-22. *Limited subset of patients. ASCENT ...

7.

atsjournals.org

atsjournals.org/doi/abs/10.1164/ajrccm.2025.211.Abstracts.A6419

Changes in Cardiac Effort in Pulmonary Hypertension ...

The ASCENT trial demonstrates that Cardiac Effort shows early insight into physiologic improvements in PH-ILD after treatment with LIQ861.