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)
1 other identifier
interventional
232
18 countries
85
Brief Summary
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2024
Longer than P75 for phase_1
85 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2024
CompletedFirst Posted
Study publicly available on registry
October 18, 2024
CompletedStudy Start
First participant enrolled
October 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
April 29, 2026
April 1, 2026
4.1 years
October 17, 2024
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Part A- Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Safety endpoints, including vital signs, ECG, clinical laboratory evaluations and adverse events up to and including the end-of-study visit.
Baseline to Day 35
Part B-Treatment Period 1: Change in pulmonary vascular resistance (PVR)
PVR is a hemodynamic variable of pulmonary circulation and is measured by right heart catheterization.
Baseline to Week 24
Part B-Treatment Period 2: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Safety endpoints, including vital signs, ECG, clinical laboratory evaluations, treatment-emergent adverse events and discontinuations due to adverse events.
From Day 1 until Week 106
Secondary Outcomes (10)
Part A- Maximum observed plasma concentrations (Cmax)
Baseline to Day 35
Part A- Time to reach maximum plasma concentration (Tmax)
Baseline to Day 35
Part A- Area under plasma concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)
Baseline to Day 35
Part A- Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC[0-inf])
Baseline to Day 35
Part A- Terminal elimination half-life (T1/2)
Baseline to Day 35
- +5 more secondary outcomes
Study Arms (4)
LTP001 Dose 1
EXPERIMENTALLTP001 Dose 2
EXPERIMENTALLTP001 Dose 3
EXPERIMENTALPlacebo
PLACEBO COMPARATORmatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- Healthy males and non-child-bearing potential females
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (85)
Arizona Pulmonary Specialists Ltd
Scottsdale, Arizona, 85258, United States
UC Irvine Medical Center
Orange, California, 92868-3298, United States
Stanford Medical Center
Stanford, California, 94305, United States
Univ Colorado Hospital
Aurora, Colorado, 80045, United States
Central Florida Pulmonary Group
Orlando, Florida, 32803-5734, United States
University of South Florida
Tampa, Florida, 33606-3475, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
U of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Norton Infectious Diseases Specialists
Louisville, Kentucky, 40202, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Sky Integrative Medical Center SKYCRNG PPDS
Ridgeland, Mississippi, 39157-5179, United States
Summit Health Eastside Clinic
Bend, Oregon, 97701, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4756, United States
Statcare Pulmonary Consultants
Knoxville, Tennessee, 37919, United States
PPD Development LP
Austin, Texas, 78744, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
The University of Utah
Salt Lake City, Utah, 84132-0001, United States
Pul Ass Richmond Inc P A R
Richmond, Virginia, 23230-1709, United States
Novartis Investigative Site
Buenos Aires, Buenos Aires F.D., 1199, Argentina
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CABA, C1426ABP, Argentina
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Río Cuarto, X5800AEV, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Santa Fe, S3000EOZ, Argentina
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Camperdown, New South Wales, 2050, Australia
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Darlinghurst, New South Wales, 2010, Australia
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New Lambton Heights, New South Wales, 2305, Australia
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Adelaide, South Australia, 5000, Australia
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Leuven, Vlaams Brabant, 3000, Belgium
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Porto Alegre, Rio Grande do Sul, 90035-074, Brazil
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Prague, 128 08, Czechia
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Prague, 14021, Czechia
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Angers, France, 49933, France
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Brest, 29200, France
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Clamart, 92141, France
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Grenoble, 38043, France
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Montpellier, 34295, France
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Nice, 06001, France
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Pessac, 33604, France
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Poitiers, 86021, France
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Saint-Priest-en-Jarez, 42270, France
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Strasbourg, 67091, France
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Toulouse, 31059, France
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Vandœuvre-lès-Nancy, 54511, France
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Regensburg, Bavaria, 93053, Germany
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Dresden, Saxony, 01307, Germany
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Berlin, 13125, Germany
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Berlin, 14050, Germany
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Giessen, 35392, Germany
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Greifswald, 17475, Germany
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Heidelberg, 69120, Germany
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Homburg, 66421, Germany
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Athens, 106 76, Greece
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Chaïdári, 124 62, Greece
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Thessaloniki, 54636, Greece
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Foggia, FG, 71122, Italy
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Monza, MB, 20900, Italy
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Palermo, PA, 90127, Italy
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Pavia, PV, 27100, Italy
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Roma, RM, 00161, Italy
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Sassari, SS, 07100, Italy
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Ivrea, TO, 10015, Italy
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Trieste, TS, 34149, Italy
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Riga, LV 1002, Latvia
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Monterrey, Nuevo León, 64460, Mexico
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San Luis Potosí City, San Luis Potosí, 78200, Mexico
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Poznan, 61 545, Poland
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Almada, 2805-267, Portugal
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Lisbon, 1769 001, Portugal
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Timișoara, Timiș County, 300310, Romania
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Bucharest, 050159, Romania
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Belgrade, Serbia, 11000, Serbia
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Kamenitz, 21204, Serbia
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Niš, 18108, Serbia
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Santiago Compostela, A Coruna, 15706, Spain
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Marbella, Andalusia, 29600, Spain
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Toledo, Castille-La Mancha, 45071, Spain
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Barcelona, Catalonia, 08003, Spain
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Las Palmas de Gran C, Las Palmas, 35016, Spain
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Barcelona, 08035, Spain
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Seville, 41013, Spain
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Sheffield, South Yorkshire, S10 2JF, United Kingdom
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Cambridge, CB2 0AY, United Kingdom
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London, EC1A 7BE, United Kingdom
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London, SW3 6PH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2024
First Posted
October 18, 2024
Study Start
October 24, 2024
Primary Completion (Estimated)
November 29, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.