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RECRUITING
NCT07481981
PHASE3

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

344

Start Date

2026-07-21

Completion Date

2029-01-28

Last Updated

2026-09-16

Healthy Volunteers

No

Interventions

DRUG

Treprostinil Palmitil Inhalation Powder

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

DRUG

Placebo

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

Locations (26)

USA012

Los Angeles, California, United States

USA008

Santa Barbara, California, United States

USA005

Torrance, California, United States

USA010

Kansas City, Kansas, United States

USA028

Omaha, Nebraska, 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

ISR004

Petah Tikva, Israel

ISR005

Ramat Gan, Israel

ISR003

Tel Aviv, Israel

JPN011

Narashino, Chiba, Japan

JPN015

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

JPN007

Sapporo, Hokkaido, Japan

JPN002

Sapporo, Hokkaido, Japan

JPN014

Kobe, Hyōgo, Japan

JPN003

Okayama, Okayama-ken, Japan

JPN017

Minato-ku, Tokyo, Japan

NZL001

Auckland, New Zealand

NZL003

Dunedin, New Zealand

NZL002

Hamilton, New Zealand