RecruitingPhase 3NCT07481981

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


Sponsor

Insmed Incorporated

Enrollment

344 participants

Start Date

Jul 21, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Treprostinil Palmitil Inhalation Powder for people with pulmonary arterial hypertension. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTreprostinil Palmitil Inhalation Powder

Oral inhalation using a capsule-based dry powder inhaler device.

DRUGPlacebo

Oral inhalation using a capsule-based dry powder inhaler device.


Locations(20)

USA012

Los Angeles, California, United States

USA008

Santa Barbara, California, United States

USA005

Torrance, California, United States

USA013

Rochester, New York, United States

USA006

Philadelphia, Pennsylvania, United States

USA007

Anderson, South Carolina, United States

ARG001

Buenos Aires, Buenos Aires F.D., Argentina

ARG004

Río Cuarto, Córdoba Province, Argentina

AUS002

Camperdown, New South Wales, Australia

AUS003

Westmead, New South Wales, Australia

ISR001

Jerusalem, Israel

ISR005

Ramat Gan, Israel

ISR003

Tel Aviv, Israel

JPN011

Narashino, Chiba, Japan

JPN015

Yahatanishi-ku, Kita Kyushu-shi, Fukuoka, Japan

JPN014

Kobe, Hyōgo, Japan

JPN003

Okayama, Okayama-ken, Japan

NZL001

Auckland, New Zealand

NZL003

Dunedin, New Zealand

NZL002

Hamilton, New Zealand

View Full Details on ClinicalTrials.gov

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NCT07481981


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