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NCT06649110RecruitingPhase 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: ClinicalTrials.gov · Last updated 21 Jul 2026

Brief summary (registry, in English)

A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
232 (estimated)
First submitted
17 Oct 2024
Start date
24 Oct 2024
Primary completion date
29 Nov 2028
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT06649110

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 232
  • From 24 Oct 2024 to the primary completion date, 29 Nov 2028
  • 81 sites in 18 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Part A Inclusion Criteria:
  • Healthy males and non-child-bearing potential females
    • Part A Exclusion Criteria:
  • Clinically significant ECG or cardiac abnormalities, any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the participant in the study Other protocol-defined inclusion/exclusion criteria may apply.
  • For Japanese cohorts: participants per protocol should be first generation Japanese or up to third generation Japanese as defined in inclusion criteria 7 of the protocol.
    • Part B Inclusion Criteria:
    • -Confirmed diagnosis of PAH, pre-randomization PVR ≥400 dyn.sec.cm-5, treatment with stable doses of standard-of-care PAH therapies, 6-minute walk distance ≥ 150 m and ≤450 m.
    • Part B Exclusion Criteria:
    • Any surgical or medical condition which may place the participant at higher risk from his/her participation in the study Women of child-bearing potential unless they are using highly effective methods of contraception Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 24 hours after stopping study treatment.
    • History of hypersensitivity to any of the study treatments or excipients
    • Other protocol-defined inclusion / exclusion criteria may apply

Age in the registry: 18 years to 100 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (81)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Novartis Investigative Site
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Buenos AiresArgentinaRecruiting
Novartis Investigative Site
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CABAArgentinaRecruiting
Novartis Investigative Site
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Río CuartoArgentinaRecruiting
Novartis Investigative Site
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San Miguel de TucumánArgentinaRecruiting
Novartis Investigative Site
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Santa FeArgentinaRecruiting
Novartis Investigative Site
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AdelaideAustraliaRecruiting
Novartis Investigative Site
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CamperdownAustraliaRecruiting
Novartis Investigative Site
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DarlinghurstAustraliaRecruiting
Novartis Investigative Site
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New Lambton HeightsAustraliaRecruiting
Novartis Investigative Site
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LeuvenBelgiumRecruiting
Novartis Investigative Site
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Porto AlegreBrazilRecruiting
Novartis Investigative Site
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PragueCzechiaRecruiting
Novartis Investigative Site
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BerlinGermanyRecruiting
Novartis Investigative Site
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DresdenGermanyRecruiting
Novartis Investigative Site
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GiessenGermanyRecruiting
Novartis Investigative Site
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GreifswaldGermanyRecruiting
Novartis Investigative Site
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HeidelbergGermanyRecruiting
Novartis Investigative Site
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HomburgGermanyRecruiting
Novartis Investigative Site
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RegensburgGermanyRecruiting
Novartis Investigative Site
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BarcelonaSpainRecruiting
Novartis Investigative Site
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Las Palmas de Gran CSpainRecruiting
Novartis Investigative Site
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MarbellaSpainRecruiting
Novartis Investigative Site
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Santiago CompostelaSpainRecruiting
Novartis Investigative Site
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SevilleSpainRecruiting
Novartis Investigative Site
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ToledoSpainRecruiting
Novartis Investigative Site
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AngersFranceRecruiting
Novartis Investigative Site
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BrestFranceRecruiting
Novartis Investigative Site
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ClamartFranceRecruiting
Novartis Investigative Site
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GrenobleFranceRecruiting
Novartis Investigative Site
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MontpellierFranceRecruiting
Novartis Investigative Site
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NiceFranceRecruiting
Novartis Investigative Site
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PessacFranceRecruiting
Novartis Investigative Site
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PoitiersFranceRecruiting
Novartis Investigative Site
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Saint-Priest-en-JarezFranceRecruiting
Novartis Investigative Site
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StrasbourgFranceRecruiting
Novartis Investigative Site
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ToulouseFranceRecruiting
Novartis Investigative Site
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Vandœuvre-lès-NancyFranceRecruiting
Novartis Investigative Site
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CambridgeUnited KingdomRecruiting
Novartis Investigative Site
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LondonUnited KingdomRecruiting
Novartis Investigative Site
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SheffieldUnited KingdomRecruiting
Novartis Investigative Site
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AthensGreeceRecruiting
Novartis Investigative Site
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ChaïdáriGreeceRecruiting
Novartis Investigative Site
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ThessalonikiGreeceRecruiting
Novartis Investigative Site
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FoggiaItalyRecruiting
Novartis Investigative Site
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IvreaItalyRecruiting
Novartis Investigative Site
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MonzaItalyRecruiting
Novartis Investigative Site
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PalermoItalyRecruiting
Novartis Investigative Site
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PaviaItalyRecruiting
Novartis Investigative Site
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RomaItalyRecruiting
Novartis Investigative Site
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SassariItalyRecruiting
Novartis Investigative Site
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TriesteItalyRecruiting
Novartis Investigative Site
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RigaLatviaRecruiting
Novartis Investigative Site
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MonterreyMexicoRecruiting
Novartis Investigative Site
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San Luis Potosí CityMexicoRecruiting
Novartis Investigative Site
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PoznanPolandRecruiting
Novartis Investigative Site
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AlmadaPortugalRecruiting
Novartis Investigative Site
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LisbonPortugalRecruiting
Novartis Investigative Site
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BucharestRomaniaRecruiting
Novartis Investigative Site
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TimișoaraRomaniaRecruiting
Novartis Investigative Site
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BelgradeSerbiaRecruiting
Novartis Investigative Site
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KamenitzSerbiaRecruiting
Novartis Investigative Site
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NišSerbiaRecruiting
Emory University School of Medicine
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AtlantaUnited StatesRecruiting
Univ Colorado Hospital
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AuroraUnited StatesRecruiting
PPD Development, LP
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AustinUnited StatesRecruiting
Summit Health Eastside Clinic
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BendUnited StatesRecruiting
Tufts Medical Center
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BostonUnited StatesRecruiting
Lahey Hospital and Medical Center
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BurlingtonUnited StatesRecruiting
UT Southwestern Medical Center
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DallasUnited StatesRecruiting
U of Kansas Medical Center
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Kansas CityUnited StatesRecruiting
Statcare Pulmonary Consultants
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KnoxvilleUnited StatesRecruiting
Norton Infectious Diseases Specialists
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LouisvilleUnited StatesRecruiting
UC Irvine Medical Center
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OrangeUnited StatesRecruiting
Central Florida Pulmonary Group
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OrlandoUnited StatesRecruiting
Allegheny General Hospital
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PittsburghUnited StatesRecruiting
Pul Ass Richmond Inc P A R
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RichmondUnited StatesRecruiting
Sky Integrative Medical Center SKYCRNG PPDS
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RidgelandUnited StatesRecruiting
The University of Utah
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Salt Lake CityUnited StatesRecruiting
Arizona Pulmonary Specialists Ltd
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ScottsdaleUnited StatesRecruiting
Stanford Medical Center
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StanfordUnited StatesRecruiting
University of South Florida
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TampaUnited StatesRecruiting

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