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NCT Number: NCT07759804

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Southeastern Cardiology Associates

Columbus, Georgia, 31904, United States

Location contact

Hunter Champion, MD, PhD

CONTACT

[email protected]

1-888-241-6906

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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)

Study contacts

Contact information is provided by the study sponsor or research team.

Liquidia Point of Contact

CONTACT

[email protected]

1-888-241-6906

Sponsors and collaborators

Lead sponsor

Liquidia Technologies, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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