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RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 16 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will take LIQ861 for 16 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe inhaled LIQ861 (treprostinil) is and how well adults with pulmonary arterial hypertension (PAH) can handle it after switching from selexipag pills. PAH is high blood pressure in the arteries of the lungs. Everyone will use LIQ861 four times a day for 16 weeks, and the study will also check walking distance, signs of heart strain in the blood, and symptoms.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 80 years old.
  • Have WHO Group 1 PAH confirmed by a right heart catheter test, which uses a thin tube to measure pressure.
  • Have PAH with no known cause, an inherited cause, a drug or toxin cause, or a link to connective tissue disease. PAH linked to certain simple heart defects repaired at least 1 year ago also qualifies.
  • Have taken selexipag at 200 to 1600 micrograms twice a day for at least 90 days.
  • Be willing and able to switch to LIQ861 because selexipag has not worked well enough or has caused problems you cannot tolerate.
  • You may take up to 2 other approved PAH pills that are not prostacyclin medicines. Their doses and schedules must be stable and stay unchanged during the study.
  • Have NYHA Class II or III symptoms, meaning symptoms limit physical activity.
  • Be able to show that you can use the dry powder inhaler correctly.

Who can't join

  • Have WHO Group 2, 3, 4, or 5 pulmonary hypertension, or a Group 1 type not listed above.
  • Have significant disease on the left side of the heart shown by a heart ultrasound. This includes a pumping measure of 45% or less, an enlarged upper-left heart chamber above the study's size limit, or valve disease that greatly affects blood flow.
  • Have had symptoms from disease in the heart's blood vessels within the past 6 months.
  • Have had an atrial septostomy, a procedure that makes an opening between the heart's two upper chambers.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

GA