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Not yet recruitingNCT07759804Updated Aug 12, 2026

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

A Phase 4 interventional study of LIQ861 (treprostinil) inhalation powder in Pulmonary Arterial Hypertension (PAH), sponsored by Liquidia Technologies, Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Liquidia Technologies, Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

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.

02

Conditions studied

  • Pulmonary Arterial Hypertension (PAH)

Keywords

  • pulmonary arterial hypertension
  • PAH
  • selexipag
  • prostacyclin
  • dry powder inhaler
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Selexipag to LIQ861 (treprostinil) inhalation powder

    Combination Product: LIQ861 (treprostinil) inhalation powder

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.

05

What researchers measure

Primary outcomes

  1. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Time frame: Day 1 through 30 days after the last dose of study drug (up to approximately 24 weeks)

06

Study locations

1 site
  • Southeastern Cardiology Associates
    Columbus, Georgia 31904, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07759804
Lead sponsor
Liquidia Technologies, Inc.
Responsible party
Sponsor
First posted
Aug 12, 2026
Start date
Sep 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Aug 12, 2026

Study contacts

Liquidia Point of Contact
Contact
LiquidiaStudies@liquidia.com
1-888-241-6906

Oversight

FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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