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Ltp001

Clinical trials are studying Ltp001 in people with idiopathic pulmonary fibrosis and pulmonary arterial hypertension, as well as in healthy volunteers in one part of a study. These trials are looking at safety, tolerability, and possible benefit, with outcomes such as lung function and pulmonary vascular resistance.

Table of Contents

Trial overview

Two interventional studies are investigating Ltp001 in different groups of participants.[1][2] One study is in people with idiopathic pulmonary fibrosis, or IPF, and the other study includes healthy volunteers in Part A and people with pulmonary arterial hypertension, or PAH, in Part B.[1][2] The IPF study is Phase 2 and was completed, while the other study is Phase 1 and was authorised.[1][2]

Idiopathic pulmonary fibrosis study

The IPF trial studied whether investigational products, including Ltp001 and placebo, could improve lung function in participants with idiopathic pulmonary fibrosis.[1] The study was designed to compare treatment with placebo over 26 weeks of treatment.[1] Its main goal was to assess efficacy, which means whether the treatment may work for the disease.[1]

This study enrolled 109 participants and was completed.[1] The primary endpoint was the change from baseline to the end of treatment in Forced Vital Capacity (FVC), expressed as percent predicted.[1] Percent predicted means the result is compared with what would be expected for a healthy person of the same age, sex, height, and background.[1]

Healthy volunteers and PAH study

The second study is a Phase 1 trial that looks at safety and tolerability of Ltp001.[2] Part A includes healthy participants and is noted as not applicable to the EU, for information only.[2] Part B includes participants with pulmonary arterial hypertension and is focused on both treatment effects and safety.[2]

In Part A, the study assesses single and multiple doses of Ltp001 in healthy participants and measures safety endpoints such as vital signs, ECG, central lab evaluations, and adverse events up to the end-of-study visit.[2] In Part B, Period 1 evaluates the dose-response relationship of Ltp001 plus standard-of-care compared with placebo plus standard-of-care in participants with WHO functional class II-III PAH.[2] Period 2 then continues to assess safety and tolerability, including treatment-emergent adverse events and discontinuations due to adverse events.[2]

This study has an enrollment of 121 participants and is authorised.[2]

Outcomes and endpoints

The main outcome in the IPF study is the change in FVC from baseline after 26 weeks of treatment.[1] This tells researchers whether lung function changed during the study.[1]

In the PAH study, the main outcome in Period 1 is the change in PVR from baseline to 24 weeks.[2] PVR is a measure of how hard it is for blood to flow through the blood vessels in the lungs.[2] In Period 2, the study tracks safety endpoints such as vital signs, ECG, central lab tests, treatment-emergent adverse events, and stopping treatment because of adverse events.[2]

Who could participate

The IPF study was for participants with idiopathic pulmonary fibrosis.[1] The PAH study had two different groups: healthy volunteers in Part A and participants with WHO functional class II-III PAH in Part B.[2] WHO functional class II-III means symptoms affect daily activity to a moderate degree.[2]

  • IPF participants: People with idiopathic pulmonary fibrosis who joined a Phase 2 treatment study.[1]

  • Healthy volunteers: People without the target disease who helped researchers study early safety in Part A.[2]

  • PAH participants: People with pulmonary arterial hypertension in WHO functional class II-III who took part in Part B.[2]

What the trials measured

These trials focused on whether Ltp001 could help in the studied diseases and whether it could be given safely.[1][2] In IPF, the key measure was lung function using FVC.[1] In PAH, the key measure was PVR, along with safety checks such as vital signs, ECG, lab tests, and adverse events.[2]

The studies used placebo comparison in both settings, which helps show whether changes are likely due to Ltp001 rather than chance or other care.[1][2] The PAH study also used standard-of-care treatment, meaning the usual treatment given for the condition.[2]

Trial ID Phase Condition studied Status Enrollment
2023-508729-28-00 Phase 2 Idiopathic pulmonary fibrosis Completed 109
2024-513613-12-00 Phase 1 Healthy volunteers; pulmonary arterial hypertension Authorised 121

FAQ

  • What conditions are being studied in Ltp001 trials? The trials are studying idiopathic pulmonary fibrosis, called IPF, and pulmonary arterial hypertension, called PAH. One study also includes healthy volunteers in a separate part.
  • Who can take part in the Ltp001 studies? One study includes adults with IPF. Another study includes healthy participants in Part A and people with WHO functional class II-III PAH in Part B.
  • What phase are the Ltp001 trials? The IPF study is Phase 2. The study in healthy participants and PAH is Phase 1.
  • What are the trials trying to find out? The trials are checking whether Ltp001 is safe and whether it may help with the studied conditions. They also look at how treatment changes lung function in IPF and pulmonary vascular resistance in PAH.
  • What kinds of results are measured in these studies? The IPF study measures forced vital capacity, or FVC, which shows how much air a person can breathe out. The PAH study measures pulmonary vascular resistance, or PVR, and also tracks safety results such as vital signs, ECGs, lab tests, and adverse events.

Ongoing Clinical Trials on Ltp001

  • A study of LTP001 in combination with standard treatment for adults with pulmonary arterial hypertension

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Germany Greece Italy +5

  • Study on the Effectiveness and Safety of LTP001 for Patients with Idiopathic Pulmonary Fibrosis

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Czechia Germany The Netherlands Poland

Glossary

  • Idiopathic pulmonary fibrosis (IPF): A long-term lung disease that causes scarring in the lungs. Idiopathic means the cause is not known.
  • Pulmonary arterial hypertension (PAH): High blood pressure in the arteries that carry blood from the heart to the lungs.
  • Phase 1: An early trial phase that mainly checks safety, tolerability, and how the treatment behaves in people.
  • Phase 2: A trial phase that looks more closely at whether a treatment may help a disease and continues safety testing.
  • Placebo: A treatment that looks like the study drug but does not contain the active drug. It helps compare results fairly.
  • Forced Vital Capacity (FVC): The amount of air a person can forcefully breathe out after taking a deep breath. It helps show how well the lungs work.
  • Pulmonary Vascular Resistance (PVR): A measure of how hard it is for blood to flow through the blood vessels in the lungs.
  • Standard-of-care (SoC): The usual treatment that people normally receive for a condition.
  • WHO functional class: A scale that shows how much a lung or heart condition affects daily activity. Class II-III means symptoms affect activity to a moderate degree.
  • Electrocardiogram (ECG): A test that records the electrical activity of the heart.
  • Adverse events (AEs): Medical problems or unwanted effects that happen during a study, whether or not they are caused by the treatment.
  • Tolerability: How well people can take a treatment without having too many difficult side effects or problems.

References

  1. https://clinicaltrials.gov/study/2023-508729-28-00
  2. https://clinicaltrials.gov/study/2024-513613-12-00