RecruitingPulmonary Arterial Hypertension
A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)
Eligible age
18–75 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP compared with placebo on exercise capacity in adults with PAH.
Sponsor: Insmed Incorporated
You may qualify if…
- ✓ Participants must have a diagnosis of World Health Organisation (WHO) Group 1 pulmonary hypertension (PAH) in any of the following subtypes, in accordance with European Society of Cardiology European Respiratory Society (ESC/ERS) Guidelines:
- ✓ Idiopathic PAH
- ✓ Heritable PAH
- ✓ Drug/toxin-induced PAH
- ✓ Connective tissue disease (CTD)-associated PAH
- ✓ PAH associated with congenital heart disease-related to simple systemic-to-pulmonary shunt at least 1 year following repair.
- ✓ PAH diagnosis for at least 3 months prior to Screening.
- ✓ New York Heart Association (NYHA) or World Health Organization (WHO) functional class II-IV.
You may not qualify if…
- ✕ Diagnosis of PH WHO Groups 2, 3, 4, or 5, or subtypes of PH WHO Group 1 other than described in inclusion criterion 2 (eg, human immunodeficiency virus (HIV), complex congenital heart disease-associated PAH, portal hypertension-associated PAH, pulmonary veno-occlusive disease, Schistosomiasis associated PAH).
- ✕ Clinically significant left heart disease, including left-sided valvular disease, left ventricular systolic or diastolic dysfunction, echocardiographic findings suggestive of post-capillary pulmonary hypertension, unstable ischemic heart disease, or unstable arrhythmias.
- ✕ Evidence of airflow obstruction defined by forced expiratory volume in 1 second (FEV1) per forced vital capacity (FVC) \<0.7.
- ✕ Evidence of significant restrictive lung disease as evidenced by FVC \<70% predicted normal.
- ✕ Evidence of chronic thromboembolic disease or recent (within 6 months of Screening) acute pulmonary embolism.
- ✕ Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (e.g., mannitol, leucine).
- ✕ Any other medical or psychological condition including relevant laboratory abnormalities at Screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease and/or may present an unreasonable risk to the study participant as a result of his/her participation in this clinical trial, may impede their ability complete the study or the study assessments or confound the outcomes of the trial.
- ✕ Note: Other protocol-defined inclusion/exclusion criteria may apply.
Where it's recruiting
California
Santa Barbara
South Carolina
Anderson
Source: ClinicalTrials.gov · NCT07481981 · last updated 2026-06-10