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Treprostinil Palmitil

Clinical trials are studying Treprostinil Palmitil in people with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. These studies look at safety, tolerability, and how well the treatment may work. The trial data include completed and authorized studies in different phases.

Table of Contents

Trial overview

The trial data show four interventional studies of Treprostinil Palmitil, also called TPIP in the study summaries.[1][2][3][4] These studies are testing the inhalation powder form in people with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.[1][2][3][4]

Conditions studied

Pulmonary arterial hypertension is the main condition in two trials, NCT05147805 and NCT05649748.[1][3] Another two studies focus on pulmonary hypertension associated with interstitial lung disease, which is a form of high blood pressure in the lungs linked to lung scarring.[2][4]

The trial summaries do not describe other disease groups, so the research focus is limited to these two lung blood pressure conditions.[1][2][3][4]

Trial phases and study designs

The studies include Phase 2, Phase 3, and Phase 4 trials.[1][2][3][4] Phase 2 usually explores early signs of benefit and gathers more safety data, while Phase 3 is a larger test of whether the treatment works better than placebo.[1][4] Phase 4 studies are later studies that look at longer-term safety and tolerability.[2][3]

All four trials are interventional studies, which means the research team gives a study treatment and then measures the results.[1][2][3][4] The trial designs include placebo-controlled studies, randomized studies, double-blind studies, multicenter studies, and parallel group studies in the Phase 3 PH-ILD trial.[4]

Main endpoints and what they mean

One key endpoint is pulmonary vascular resistance (PVR), which measures how hard it is for blood to move through the blood vessels in the lungs.[1] In NCT05147805, the main endpoint is the change in PVR from baseline to Week 16.[1]

Another important endpoint is 6-minute walk distance (6MWD), which shows how far a person can walk in 6 minutes and helps measure exercise capacity.[4] In the Phase 3 PH-ILD study, the main endpoint is the change in 6MWD measured at peak exposure from baseline to Week 24.[4]

Two Phase 4 studies focus on the frequency and severity of treatment-emergent adverse events (TEAEs), which are health problems that appear during the study after treatment starts.[2][3] These studies are designed to learn more about safety and tolerability during longer use.[2][3]

Who can participate

The studies are for people who already have the target conditions named in the trial records: pulmonary arterial hypertension or pulmonary hypertension associated with interstitial lung disease.[1][2][3][4] One Phase 4 PH-ILD study also includes participants from earlier lead-in studies, showing that some trials follow people over time after earlier research steps.[2]

The trial data do not provide detailed age limits, test results, or other screening rules, so those details cannot be added here.[1][2][3][4]

Trial status and size

Two studies are marked Completed, and two are marked Authorised.[1][2][3][4] The enrollment numbers range from 39 participants in one Phase 4 study to 361 participants in the Phase 3 PH-ILD study.[2][4]

The Phase 2 PAH study enrolled 99 participants, and the Phase 4 PAH study enrolled 93 participants.[1][3] This mix of smaller and larger studies helps researchers look at both detailed outcomes and broader study results.[1][2][3][4]

Trial ID Phase Condition studied Status Enrollment Main endpoint
NCT05147805 Phase 2 Pulmonary Arterial Hypertension Completed 99 Change from Baseline in PVR at Week 16
NCT05649722 Phase 4 Pulmonary Hypertension Associated with Interstitial Lung Disease Completed 39 Frequency and severity of TEAEs during the study
NCT05649748 Phase 4 Pulmonary Arterial Hypertension Authorised 93 Frequency and severity of TEAEs during the study
2025-521558-40-00 Phase 3 Pulmonary Hypertension Associated with Interstitial Lung Disease Authorised 361 Change in 6MWD measured at peak exposure from Baseline to Week 24

FAQ

  • What conditions are being studied with Treprostinil Palmitil? The trials focus on pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. These are forms of high blood pressure in the lungs.
  • What are the main goals of these trials? The studies are looking at safety, tolerability, and whether Treprostinil Palmitil can improve exercise ability or pulmonary vascular resistance. Some trials also measure long-term safety.
  • What trial phases are included? The trial data include Phase 2, Phase 3, and Phase 4 studies. Phase 2 and Phase 3 usually look at how well a treatment works, while Phase 4 studies often look at longer-term safety after earlier trials.
  • Who may take part in these studies? Participants in the trials have either pulmonary arterial hypertension or pulmonary hypertension associated with interstitial lung disease. Some studies also include people who joined earlier lead-in studies.
  • What outcomes are researchers measuring? Researchers measure pulmonary vascular resistance, which shows how hard it is for blood to flow through the lung vessels. They also measure the 6-minute walk distance and the frequency and severity of treatment-emergent side effects.

Ongoing Clinical Trials on Treprostinil Palmitil

  • Testing Treprostinil Palmitil Inhalation Powder for Improving Exercise Ability in Patients with Pulmonary Hypertension Related to Interstitial Lung Disease

    Recruiting

    1 1
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +6

  • Study on Long-Term Safety and Effectiveness of Treprostinil Palmitil for Patients with Pulmonary Arterial Hypertension

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Denmark Germany Italy Spain

  • Study on Treprostinil Palmitil Inhalation Powder for Patients with Pulmonary Hypertension and Interstitial Lung Disease

    Not recruiting

    1 1
    Investigated drugs:
    Belgium Germany Italy Spain

  • Study on Treprostinil Palmitil Inhalation Powder for Patients with Pulmonary Arterial Hypertension

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Denmark Germany Italy Spain

Glossary

  • Pulmonary arterial hypertension (PAH): A type of high blood pressure that affects the arteries in the lungs.
  • Pulmonary hypertension associated with interstitial lung disease (PH-ILD): High blood pressure in the lungs that happens together with interstitial lung disease, which is a group of lung diseases that cause scarring.
  • Interstitial lung disease: A group of lung conditions that can cause inflammation and scarring in the lungs.
  • Phase 2: An early study phase that often looks at how well a treatment works and collects more safety information.
  • Phase 3: A larger study phase that compares a treatment with placebo to see how well it works and how safe it is.
  • Phase 4: A later study phase that often looks at long-term safety and tolerability after earlier studies.
  • Placebo: A study treatment that looks like the real treatment but does not contain the active study drug.
  • Pulmonary vascular resistance (PVR): A measure of how much resistance blood meets as it flows through the blood vessels in the lungs.
  • 6-minute walk distance (6MWD): A test that measures how far a person can walk in 6 minutes. It helps show exercise ability.
  • Treatment-emergent adverse events (TEAEs): Health problems or side effects that happen during a study after treatment starts.
  • Tolerability: How well people can handle a treatment without major problems.
  • Enrollment: The number of participants planned or included in a study.

References