RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Liquidia Technologies, Inc. • ClinicalTrials.gov ID: NCT07759804

Registry updated: 2026-10-02

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Description

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.

Interventions

LIQ861 (treprostinil) inhalation powder (Combination product)
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.

Eligibility criteria

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

Conditions

Pulmonary Arterial Hypertension (PAH)

Locations

Southeastern Cardiology Associates — Columbus, Georgia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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