Recruiting
Phase 3

TPIP

Sponsor:

Insmed Incorporated

Code:

NCT07234032

Conditions

Pulmonary Hypertension

Interstitial Lung Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Treprostinil Palmitil Inhalation Powder

Placebo

Study Details

Brief summary:

The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).

Conditions

Pulmonary Hypertension

Interstitial Lung Disease

Study ID

NCT07234032

Start date

Jul 20, 2026

Status verified date

Aug, 2026

Completion date

Jan 22, 2031

Anticipated

Primary completion date

Jan 22, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311 (NCT07179380).
  • Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Agree not to participate in any other interventional trials or use investigational drugs or devices while participating in the INS1009-312 study.

Exclusion Criteria

  • Participants who experienced any adverse events (AEs) evaluated as causally related to TPIP by the Investigator in a lead-in study, which in the opinion of the Investigator, could pose an unreasonable risk of continued treatments for the participant.
  • Current use or expected need for pulmonary arterial hypertension (PAH)-approved therapy, including prostacyclin, prostacyclin analogues or other prostacyclin receptor agonists, endothelin receptor antagonists, and/or soluble guanylate cyclase stimulator, or any PH-ILD approved treprostinil therapy. Use of phosphodiesterase 5 inhibitors in line with applicable guidelines is allowed.
  • Diagnosis of Pulmonary Hypertension World Health Organisation (WHO) Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease (including combined pulmonary fibrosis and emphysema).
  • Evidence of left ventricular failure, heart failure with preserved ejection fraction (HFpEF) or postcapillary PH.
  • Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine).

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Enrollment

344 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treprostinil Palmitil Inhalation Powder (TPIP)

Participants transitioning from study INS1009-311 (NCT07179380) will undergo an initial double-dummy titration with the stable dose from the lead-in study and either TPIP or placebo for 4 weeks. They will then receive open-label TPIP at a stable maintenance dose with optional escalation (80-1280 micrograms once daily) for the remainder of the 104-week treatment period.

Interventions

Treprostinil Palmitil Inhalation Powder

Oral inhalation using a capsule-based dry powder.

Placebo

Oral inhalation in initial double-dummy titration period.

Primary outcome measure

  • Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 108 weeks ]

Central Contacts and Locations

Central contacts

Insmed Incorporated

18444467633medicalinformation@insmed.com

Locations

USA006

Recruiting

Naples, Florida, United States, 34102

USA003

Recruiting

Bend, Oregon, United States, 97701

More Information

Sponsor

Insmed Incorporated

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • pulmonary hypertension, interstitial lung disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Insmed Incorporated on 2026-08-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.