Taking people in ItalyPhase 1/2
Testing LTP001 in healthy adults and in people with pulmonary arterial hypertension
Tests the drug LTP001 in healthy adults and in people with pulmonary arterial hypertension.
Key facts
- Who runs it
- Novartis Pharma AG
- Where
- Foggia, Ivrea, Monza, Palermo, Pavia, Rome, Sassari, and Trieste, ItalySee the 8 sitesAlso in 11 other countries, 50 sites
- Trial code
- EU 2024-513613-12-00
- U1111-1320-5027
- Registry title
- A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 85 people, planned
- Started
- 18 Sept 2025
- Expected to end
- 31 Dec 2028
- Type of study
- Interventional
- Record updated
- 12 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with pulmonary arterial hypertension (PAH) who take stable standard PAH treatment. Part A is for healthy volunteers but does not apply in the EU.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Confirmed pulmonary arterial hypertension, WHO functional class II-III. Pre-randomization PVR ≥400 dyn.sec.cm. 6MWD ≥ 150 m and ≤550 m.
- Earlier treatment
- Part B: stable doses of standard-of-care PAH therapies.
Main reasons for not taking part
- Any surgical or medical condition that could put the person at higher risk in the study (Part B)
- Women who can have children and are not using highly effective contraception (Part B)
- Sexually active men unwilling to use a condom during the study treatment and for 24 hours after (Part B)
- History of hypersensitivity to any of the study treatments or excipients (Part B)
- Part A: heart or ECG abnormalities, other investigational drugs within 5 half-lives or within 30 days, or hypersensitivity to the study compound
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
Where in Italy
Also in 11 other countries, 50 sites
- Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, ItalyTaking people
- Azienda Sanitaria Locale TO4Ivrea, ItalyTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
- Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. I.S.M.E.T.T. S.r.l.Palermo, ItalyTaking people
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Azienda Ospedaliero-Universitaria di SassariSassari, ItalyTaking people
- Azienda Sanitaria Universitaria Giuliano IsontinaTrieste, ItalyTaking people
About the trial
What the trial wants to find out
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
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Testing LTP001 in healthy adults and in people with pulmonary arterial hypertensionGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 11 November 2026.
- Record updated
- 12 November 2026