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

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study investigates a new treatment for Pulmonary Arterial Hypertension (PAH), a condition where blood pressure in the arteries of the lungs is too high, making it harder for the heart to pump blood through the lungs. The study will test a new medication called LTP001, which comes in capsule form and is taken by mouth.

The research aims to understand if LTP001 is effective in treating people with PAH when added to their standard treatments. The study will be conducted in two parts - first testing the medication in healthy volunteers to ensure its safety, followed by testing in people who have PAH. During the study, some participants will receive LTP001 while others will receive placebo, along with their regular PAH medications.

The study will monitor how well the treatment works over 24 weeks, followed by a longer period of up to 18 months. Participants will have regular check-ups to assess their ability to walk and their overall health status. The study will look at how the treatment affects blood pressure in the lungs and how far participants can walk in a set time period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your eligibility will be confirmed through a diagnosis of pulmonary arterial hypertension

    Your walking ability will be tested - you need to be able to walk between 150 and 450 meters in the 6-minute walk test

    Your blood vessel resistance in the lungs (PVR) must be at least 400 dyn.sec.cm

    You must be on stable doses of your current medications for pulmonary arterial hypertension

  2. Step 2

    Treatment period 1 - first 24 weeks

    You will receive either LTP001 capsules or placebo capsules (capsules without active medication) to take by mouth

    You will continue taking your regular pulmonary arterial hypertension medications

    Your blood vessel resistance in the lungs will be measured to track changes

    Your walking ability will be tested again after 24 weeks

    Your heart function will be monitored through regular checks of vital signs and heart recordings (ECG)

    Blood tests will be performed to monitor your health

    Any side effects will be recorded

  3. Step 3

    Treatment period 2 - up to 18 months

    Treatment continues with LTP001 capsules

    Your walking ability will be tested again after 18 months

    Your condition will be evaluated using the WHO functional class scale, which measures how your daily activities are affected by your illness

    Regular monitoring of vital signs, heart recordings, and blood tests will continue

    Any side effects will continue to be recorded

  4. Step 4

    Study completion

    Final health evaluations will be performed

    The study will end by December 31, 2028

Who can join the trial?

8 criteria

  • Must provide signed informed consent before participating in the study
  • Must have a confirmed diagnosis of pulmonary arterial hypertension (a condition of high blood pressure in the arteries of the lungs)
  • Must have a pre-randomization PVR (pulmonary vascular resistance - a measure of blood flow resistance in lung vessels) of at least 400 dyn.sec.cm
  • Must be taking stable doses of standard PAH treatments (regular medications for pulmonary arterial hypertension)
  • Must be able to walk between 150 and 450 meters during a 6-minute walking test (6MWD)
  • Both men and women can participate in the study
  • Must be an adult (18 years or older)
  • Must be able to understand and follow study requirements

Who cannot join the trial?

15 criteria

  • Pregnant or breastfeeding women
  • People with severe liver problems (conditions affecting how the liver works)
  • Those with severe kidney disease (conditions affecting how the kidneys filter blood)
  • History of heart attack or stroke within the last 6 months
  • Uncontrolled high blood pressure (blood pressure that remains high despite treatment)
  • Active bleeding problems or high risk of bleeding
  • People taking certain medications that might interact with the study drug
  • Those participating in other clinical trials
  • Major surgery planned during the study period
  • People with severe psychiatric conditions that might affect their ability to follow study procedures
  • History of substance abuse within the past year
  • People with serious infections
  • Those allergic to the study medication or its components
  • People unable to provide informed consent
  • Those who cannot follow study procedures or attend scheduled visits
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Investigated drugs

  • LTP001

    This is an investigational medication being studied for the treatment of pulmonary arterial hypertension (PAH). It is being tested in both healthy volunteers and patients with PAH. The medication is being evaluated to understand how safe it is and how well it works when combined with standard treatments for PAH. This is a new drug that is still in the research phase, and its effects are being studied in people with moderate to severe PAH symptoms.

  • Standard-of-care medications

    These are the currently approved and commonly used medications that patients with pulmonary arterial hypertension typically receive as part of their regular treatment. During the trial, patients will continue taking these established medications while also receiving either LTP001 or placebo.

What is already known about the treatment

LTP001 - An investigational medication being studied in clinical trials for the treatment of pulmonary arterial hypertension (PAH). The drug is being evaluated alongside standard-of-care treatment in patients with WHO functional class II-III PAH, focusing on establishing its safety profile and dose-response relationship. The clinical development program consists of two parts: initial testing in healthy volunteers to assess safety and tolerability, followed by evaluation in PAH patients to determine therapeutic effectiveness. While the exact mechanism of action is not publicly disclosed in the trial data, the study aims to demonstrate the drug's potential as a new treatment option for PAH patients.

Investigated diseases

Pulmonary Arterial Hypertension (PAH) - A rare condition that affects the blood vessels in the lungs, causing them to become narrowed and thickened. This narrowing makes it harder for blood to flow through the lungs, which increases blood pressure in the pulmonary arteries. The heart must work harder to pump blood through these narrowed arteries, leading to the enlargement and weakening of the right side of the heart over time. Symptoms typically develop gradually and may include shortness of breath during physical activity, fatigue, chest pain, and dizziness. The condition can affect people of all ages, though it's more common in young adults and women.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-513613-12-00Protocol codeCLTP001A12202Estimated enrolment142 patientsSponsorNovartis Pharma AG

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).