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A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH) | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)

A Phase 3, Randomized, Double-Blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension

NCT07481981•Insmed Incorporated

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•Participants must be on stable PAH therapy consisting of 1 to 3 medications from the following classes:
•* Endothelin receptor antagonists (eg, ambrisentan, bosentan, macitentan) for at least 90 days prior to Screening with the last 30 days on stable dose.
+11 more criteria

Exclusion Criteria

•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.

Key Dates

Start Date

April 17, 2026

Primary Completion Date

December 28, 2028

Completion Date

January 28, 2029

Last Updated

March 19, 2026

Enrollment

344

ESTIMATED participants

Conditions

Pulmonary Arterial Hypertension

Interventions

Treprostinil Palmitil Inhalation Powder

DRUG

Placebo

DRUG

Contacts

Insmed Medical Information

CONTACT

18444467633 medicalinformation@insmed.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)

Inclusion Criteria

Exclusion Criteria

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