A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
NCT ID: NCT06649110
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
232 participants
INTERVENTIONAL
2024-10-24
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LTP001 Dose 1
LTP
LTP001
LTP001 Dose 2
LTP
LTP001
LTP001 Dose 3
LTP
LTP001
Placebo
matching placebo
Placebo
Placebo
Interventions
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LTP
LTP001
Placebo
Placebo
Eligibility Criteria
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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.
Exclusion Criteria
History of hypersensitivity to any of the study treatments or excipients
18 Years
100 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Stanford Medical Center
Stanford, California, United States
The Uni of Kansas Medical Center
Kansas City, Kansas, United States
Norton Infectious Diseases Specialists
Louisville, Kentucky, United States
PPD Development LP
Austin, Texas, United States
The University of Utah
Salt Lake City, Utah, United States
Pul Ass Richmond Inc P A R
Richmond, Virginia, United States
Novartis Investigative Site
Darlinghurst, New South Wales, Australia
Novartis Investigative Site
New Lambton Heights, New South Wales, Australia
Novartis Investigative Site
Riga, , Latvia
Novartis Investigative Site
Lisbon, , Portugal
Novartis Investigative Site
Bucharest, , Romania
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Phone: +41613241111
Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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CLTP001A12202
Identifier Type: -
Identifier Source: org_study_id