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

An Open-label Study to Evaluate the Safety and Tolerability of LIQ861 in Participants With WHO Group 1 PAH Transitioning From Oral Selexipag to Inhaled Treprostinil

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07759804

Enrollment

Registered

2026-08-12

Start date

2026-09-01

Completion date

2027-06-01

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension (PAH)

Keywords

pulmonary arterial hypertension, PAH, selexipag, prostacyclin, dry powder inhaler

Brief 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.

Interventions

COMBINATION_PRODUCTLIQ861 (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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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)

Countries

United States

Contacts

CONTACTLiquidia Point of Contact

LiquidiaStudies@liquidia.com1-888-241-6906

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026