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

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What is this study about?

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.

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 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 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 Study completion

Final health evaluations will be performed

The study will end by December 31, 2028

Who Can Join the Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
CHU Grenoble Alpes La Tronche France
DRK Kliniken Berlin Berlin Germany
University Medicine Greifswald Greifswald Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
Hospital Del Mar Barcelona Spain
Universitätsklinikum des Saarlandes – Homburg/Saar, Klinik für Urologie und Kinderurologie Homburg Germany
Institutul De Pneumoftiziologie Marius Nasta Bucharest Romania
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Onassis Cardiac Surgery Center Kallithea Greece
Spitalul Clinic Judetean De Urgenta Targu Mures Targu Mures Romania
Eczadeizhbov Suzq Athens Greece
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Vfsjqy dxo Raema Urstgcuaen Htaebqxf Sevilla Spain
Fuygcrirys Ioznp Pzlwzfcxcmz Suj Migppn Pavia Italy
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Jrhohkdpxinfpcfokqirqulfia Gdsznvk Giessen Germany
Ajkwati Ojqiulauewz Uvrfjfijmgxps Ovzvhees Rdscszn Foggia Italy
Vvxfuhcuo Fsmunkuv Nodqvlanp V Pqfqj Prague Czechia
Tcbpqtfkawiw Htauaangxe gjrtp Heidelberg Germany
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Udzauprsjk Gzhpqsb Hbyofxse Arfuqtj Ghzjoha Htgnrnta Ok Wpee Asnris H Acfg Vzrcwdc Chaidari Greece
Pgefl Svmlrrix Cyodcrid Ujdzzqdsja Hvgbiqse Riga Latvia
Azvzwvy Saatfumjm Uftqntiqycpyg Gfcrzpsh Iflosabv Trieste Italy
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Pnrqttkacwmoamnkal Wuppertal Germany
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Egmfkctie Iqytqkzuh Fsj Canqjbvmtobrvy Dgkzqgjt Agx Tdfhmtwtji Targu Mures Romania
Idevuvtyln Isrqsb Dl Ubqnvzb Peveqi Byfc Cixooymwddnpfix Ndrqjzp Slmarlaar Cluj Napoca Romania
Hcabaipc Cyygc dhn Sfp Marbella Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
15.09.2025
Czechia Czechia
Recruiting
15.09.2025
France France
Recruiting
15.09.2025
Germany Germany
Recruiting
15.09.2025
Greece Greece
Recruiting
15.09.2025
Italy Italy
Recruiting
15.09.2025
Latvia Latvia
Recruiting
15.09.2025
Poland Poland
Recruiting
15.09.2025
Portugal Portugal
Recruiting
15.09.2025
Romania Romania
Recruiting
15.09.2025
Spain Spain
Recruiting
15.09.2025

Trial locations

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.

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 ID:
2024-513613-12-00
Protocol code:
CLTP001A12202
Trial Phase:
Human Pharmacology (Phase I) – Other

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