2024-513613-12-00RecruitingPhase 1/2
A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of LTP001 in healthy adult participants (Part A) and to evaluate the efficacy and safety of LTP001 for the treatment of participants with pulmonary arterial hypertension (Part B)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Sept 2026
Brief summary (registry, in English)
Part A: To assess the safety and tolerability of single and multiple doses of LTP001 in healthy participants Part B: Period 1: To characterize the dose-response relationship of LTP001 plus standard-of-care (SoC) compared to placebo plus SoC in participants with WHO functional class (FC) II-III PAH Period 2: To assess the safety and tolerability of LTP001
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 89 (estimated)
- First submitted
- 30 Apr 2025
- Start date
- 18 Sept 2025
- Lead sponsor
- Novartis Pharma AG
- Diseases
- Pulmonary arterial hypertension
- EU CT number
- 2024-513613-12-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 89
- 58 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Part A: Use of any investigational drugs within 5 half-lives or within 30 days or until the expected pharmacodynamic effect has returned to baseline prior to initial dosing, whichever is longer. Part B: Women of child-bearing potential unless they are using highly effective methods of contraception
Other illness
- Part A: History or current diagnosis of clinically significant ECG or cardiac abnormalities indicating significant risk of safety for participants. Part B: Any surgical or medical condition which may place the participant at higher risk from his/her participation in the study
- Part A: History of hypersensitivity to the investigational compound/compound class or excipients being used in this study. Part B: Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 24 hours after stopping study treatment.
- Part B: History of hypersensitivity to any of the study treatments or excipients
Who the study is looking for
- Part A: Signed informed consent must be obtained prior to participation in the study. Part B: Confirmed diagnosis of pulmonary arterial hypertension
- Part A: Healthy male and non-childbearing potential female participants Part B: Pre-randomization PVR ≥400 dyn.sec.cm
- Part A: In good health in the opinion of the investigator and as determined by medical history, physical examination, vital signs, ECG, and laboratory tests. Part B: Treatment with stable doses of standard-of-care PAH therapies
- Part A: Able to read, speak, and understand the local language, to understand and comply with the requirements of the study. Part B: 6MWD ≥ 150 m and ≤550 m
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (58)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven | Leuven | Belgium | Recruiting |
| Vseobecna fakultni nemocnice v Praze | Prague | Czechia | Recruiting |
| Institute for Clinical and Experimental Medicine | Prague | Czechia | Recruiting |
| Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH | Berlin | Germany | Recruiting |
| DRK Kliniken Berlin | Berlin | Germany | Recruiting |
| Technische Universitaet Dresden | Dresden | Germany | Recruiting |
| Justus-Liebig-Universitaet Giessen | Giessen | Germany | Recruiting |
| Universitaetsmedizin Greifswald KöR | Greifswald | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany | Recruiting |
| Thoraxklinik Heidelberg gGmbH | Heidelberg | Germany | Recruiting |
| Universitaet Des Saarlandes | Homburg | Germany | Recruiting |
| Universitaetsklinikum Regensburg AöR | Regensburg | Germany | Recruiting |
| Petrus-Krankenhaus | Wuppertal | Germany | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| Hospital del Mar | Barcelona | Spain | Recruiting |
| Hospital Universitario Juan Ramon Jimenez | Huelva | Spain | Recruiting |
| Complejo Hospitalario Universitario Insular Materno Infantil | Las Palmas de Gran Canaria | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria | Málaga | Spain | Recruiting |
| Hospital Costa del Sol | Marbella | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago | Santiago de Compostela | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Recruiting |
| Hospital Universitario de Toledo | Toledo | Spain | Recruiting |
| Centre Hospitalier Universitaire D'Angers | Angers | France | Recruiting |
| Centre Hospitalier Régional et Universitaire de Brest | Brest | France | Recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes | Grenoble Cedex 9 | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Le Kremlin-Bicetre | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier | Montpellier Cedex 5 | France | Recruiting |
| Centre Hospitalier Universitaire de Nice | Nice | France | Recruiting |
| Centre Hospitalier Universitaire de Bordeaux | Pessac | France | Recruiting |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | France | Recruiting |
| Centre Hospitalier Universitaire de Saint Etienne | Saint-Priest-en-Jarez | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg | Strasbourg Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Toulouse | Toulouse | France | Recruiting |
| CHRU De Nancy | Vandoeuvre Les Nancy | France | Recruiting |
| Evangelismos S A | Athens | Greece | Recruiting |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" | Chaïdári | Greece | Recruiting |
| Onassis Cardiac Surgery Center | Kallithea | Greece | Recruiting |
| University General Hospital of Thessaloniki - AHEPA | Thessaloniki | Greece | Recruiting |
| Azienda Ospedaliero Universitaria Ospedali Riuniti | Foggia | Italy | Recruiting |
| Azienda Sanitaria Locale TO4 | Ivrea | Italy | Recruiting |
| Fondazione IRCCS San Gerardo dei Tintori | Monza | Italy | Recruiting |
| Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. I.S.M.E.T.T. S.r.l. | Palermo | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I | Rome | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria di Sassari | Sassari | Italy | Recruiting |
| Azienda Sanitaria Universitaria Giuliano Isontina | Trieste | Italy | Recruiting |
| Pauls Stradins Clinical University Hospital | Riga | Latvia | Recruiting |
| Amsterdam UMC Stichting | Amsterdam | Netherlands | Not yet recruiting |
| St. Antonius Ziekenhuis | Nieuwegein | Netherlands | Not yet recruiting |
| Wojewodzki Szpital Specjalistyczny Im. Stefana Kardynala Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lublinie | Lublin | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | Poland | Recruiting |
| Unidade Local De Saude De Almada-Seixal E.P.E. | Almada | Portugal | Recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. | Lisbon | Portugal | Recruiting |
| Unidade Local De Saude De Santo Antonio E.P.E. | Porto | Portugal | Recruiting |
| Institutul de pneumoftiziologie Marius Nasta | Bucharest | Romania | Recruiting |
| Institutul Inimii De Urgenta Pentru Boli Cardiovasculare Niculae Stancioiu | Cluj-Napoca | Romania | Recruiting |
| Spitalul Clinic Judetean de Urgenta Targu Mures | Târgu Mureş | Romania | Recruiting |
| Clinical Hospital of Infectious Diseases and Pneumophysiology Dr.Victor Babeș Timișoara | Timișoara | Romania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.