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Clinical Trials in the USA / NCT07759804
Recruiting Phase 4

A Study of Inhaled Treprostinil (LIQ861) in Adults With Pulmonary Arterial Hypertension Transitioning From Oral Selexipag

NCT07759804 · tracked via the Priya Life Science USA tracker
Sponsor
Liquidia Technologies, Inc
Phase
Phase 4
Started
2026-09
Last updated
2026-10-02

Condition(s) studied

Pulmonary Arterial Hypertension (PAH)

Investigational drug(s) / intervention(s)

LIQ861 (treprostinil) inhalation powder

LIQ861 (treprostinil) inhalation powder: Treprostinil inhalation powder supplied in capsules for oral inhalation using a handheld, single-capsule dry powder inhaler. Participants self-administer study drug four times daily (QID), and titrated on tolerability and symptom relief.

Study summary

This study will look at safety and tolerability of LIQ861 (treprostinil) inhalation powder in adults with pulmonary arterial hypertension (PAH, WHO Group 1) who switch from selexipag, a medicine taken by mouth, to treprostinil, a medicine breathed into the lungs.

Everyone who takes part will receive LIQ861. On the first study day, participants will stop taking selexipag and begin taking LIQ861 four times a day using a small handheld dry powder inhaler. The dose may be increased over time based on how well it is tolerated. Participants will take LIQ861 for 16 weeks.

The study will also look at whether switching to LIQ861 affects walking distance, a blood marker of heart strain, and symptoms reported by participants.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Male or female 18 to 80 years of age * Documented findings on right heart catheterization consistent with a diagnosis of WHO Group 1 pulmonary arterial hypertension of one of the following subtypes: idiopathic PAH; heritable PAH; drug- or toxin-induced PAH; PAH associated with connective tissue disease; or PAH associated with simple congenital systemic-to-pulmonary shunts repaired at least 1 year previously * Receiving selexipag at any dose between 200 and 1600 mcg twice daily for at least 90 days, and willing and able to transition from selexipag to LIQ861 due to unsatisfactory clinical response or tolerability issues * May be receiving up to 2 additional approved non-prostacyclin oral PAH therapies at a stable dose and regimen, planned to continue unchanged for the duration of the study * New York Heart Association Functional Class II or III * Able to demonstrate correct use of the dry powder inhaler Exclusion Criteria: * Pulmonary hypertension in WHO Group 2, 3, 4, or 5, or a WHO Group 1 subtype not listed in the inclusion criteria * Clinically significant left-sided heart disease by echocardiography, including left ventricular ejection fraction ≤ 45%, left atrial volume index \> 48 mL/m², or hemodynamically significant valvular disease * Symptomatic coronary artery disease within the previous 6 months * Prior atrial septostomy

Primary outcome measure(s)

  • Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) — Day 1 through 30 days after the last dose of study drug (up to approximately 24 weeks)

Trial sites (1)

FacilityCityRegionStatus
Southeastern Cardiology Associates Columbus Georgia Recruiting

More Liquidia Technologies, Inc. trials in the USA

A Phase 3 Study to Evaluate the Safety and Tolerability of L606 in Subjects With PAH or PH-ILD Active, not recruiting
An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH Active, not recruiting
A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD Recruiting
Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of Treprostinil Active, not recruiting

Other trials for the same condition

A Study of ROC-101 in Patients With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH) (ROCSTAR STUDY) Recruiting
Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07759804 on ClinicalTrials.gov ↗ ← All trials in the USA