Recruiting

LIQ861

Sponsor:

Liquidia Technologies, Inc.

Code:

NCT07759804

Conditions

Pulmonary Arterial Hypertension (PAH)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LIQ861 (treprostinil) inhalation powder

Study Details

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.

Conditions

Pulmonary Arterial Hypertension (PAH)

Study ID

NCT07759804

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Selexipag to LIQ861 (treprostinil) inhalation powder

Interventions

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.

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Liquidia Point of Contact

1-888-241-6906LiquidiaStudies@liquidia.com

Locations

Southeastern Cardiology Associates

Recruiting

Columbus, Georgia, United States, 31904

Contacts

Hunter Champion, MD, PhD

1-888-241-6906LiquidiaStudies@liquidia.com

More Information

Sponsor

Liquidia Technologies, Inc.

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Liquidia Technologies, Inc. on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.