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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

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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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (58)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
UZ LeuvenLeuvenBelgiumRecruiting
Vseobecna fakultni nemocnice v PrazePragueCzechiaRecruiting
Institute for Clinical and Experimental MedicinePragueCzechiaRecruiting
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbHBerlinGermanyRecruiting
DRK Kliniken BerlinBerlinGermanyRecruiting
Technische Universitaet DresdenDresdenGermanyRecruiting
Justus-Liebig-Universitaet GiessenGiessenGermanyRecruiting
Universitaetsmedizin Greifswald KöRGreifswaldGermanyRecruiting
University Medical Center Hamburg-EppendorfHamburgGermanyRecruiting
Thoraxklinik Heidelberg gGmbHHeidelbergGermanyRecruiting
Universitaet Des SaarlandesHomburgGermanyRecruiting
Universitaetsklinikum Regensburg AöRRegensburgGermanyRecruiting
Petrus-KrankenhausWuppertalGermanyRecruiting
Hospital Universitari Vall d'HebronBarcelonaSpainRecruiting
Hospital del MarBarcelonaSpainRecruiting
Hospital Universitario Juan Ramon JimenezHuelvaSpainRecruiting
Complejo Hospitalario Universitario Insular Materno InfantilLas Palmas de Gran CanariaSpainRecruiting
Hospital Universitario Virgen de la VictoriaMálagaSpainRecruiting
Hospital Costa del SolMarbellaSpainRecruiting
Complexo Hospitalario Universitario De SantiagoSantiago de CompostelaSpainRecruiting
University Hospital Virgen Del Rocio S.L.SevillaSpainRecruiting
Hospital Universitario de ToledoToledoSpainRecruiting
Centre Hospitalier Universitaire D'AngersAngersFranceRecruiting
Centre Hospitalier Régional et Universitaire de BrestBrestFranceRecruiting
Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9FranceRecruiting
Assistance Publique Hopitaux De ParisLe Kremlin-BicetreFranceRecruiting
Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5FranceRecruiting
Centre Hospitalier Universitaire de NiceNiceFranceRecruiting
Centre Hospitalier Universitaire de BordeauxPessacFranceRecruiting
Centre Hospitalier Universitaire de PoitiersPoitiersFranceRecruiting
Centre Hospitalier Universitaire de Saint EtienneSaint-Priest-en-JarezFranceRecruiting
Les Hopitaux Universitaires De StrasbourgStrasbourg CedexFranceRecruiting
Centre Hospitalier Universitaire de ToulouseToulouseFranceRecruiting
CHRU De NancyVandoeuvre Les NancyFranceRecruiting
Evangelismos S AAthensGreeceRecruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"ChaïdáriGreeceRecruiting
Onassis Cardiac Surgery CenterKallitheaGreeceRecruiting
University General Hospital of Thessaloniki - AHEPAThessalonikiGreeceRecruiting
Azienda Ospedaliero Universitaria Ospedali RiunitiFoggiaItalyRecruiting
Azienda Sanitaria Locale TO4IvreaItalyRecruiting
Fondazione IRCCS San Gerardo dei TintoriMonzaItalyRecruiting
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. I.S.M.E.T.T. S.r.l.PalermoItalyRecruiting
Fondazione IRCCS Policlinico San MatteoPaviaItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto IRomeItalyRecruiting
Azienda Ospedaliero-Universitaria di SassariSassariItalyRecruiting
Azienda Sanitaria Universitaria Giuliano IsontinaTriesteItalyRecruiting
Pauls Stradins Clinical University HospitalRigaLatviaRecruiting
Amsterdam UMC StichtingAmsterdamNetherlandsNot yet recruiting
St. Antonius ZiekenhuisNieuwegeinNetherlandsNot yet recruiting
Wojewodzki Szpital Specjalistyczny Im. Stefana Kardynala Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej W LublinieLublinPolandRecruiting
Uniwersytecki Szpital Kliniczny w PoznaniuPoznanPolandRecruiting
Unidade Local De Saude De Almada-Seixal E.P.E.AlmadaPortugalRecruiting
Unidade Local De Saude De Santa Maria E.P.E.LisbonPortugalRecruiting
Unidade Local De Saude De Santo Antonio E.P.E.PortoPortugalRecruiting
Institutul de pneumoftiziologie Marius NastaBucharestRomaniaRecruiting
Institutul Inimii De Urgenta Pentru Boli Cardiovasculare Niculae StancioiuCluj-NapocaRomaniaRecruiting
Spitalul Clinic Judetean de Urgenta Targu MuresTârgu MureşRomaniaRecruiting
Clinical Hospital of Infectious Diseases and Pneumophysiology Dr.Victor Babeș TimișoaraTimișoaraRomaniaRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.