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LTP001

Phase 1

Healthy Volunteers, Pulmonary Arterial Hypertension | Small molecule | Cardiovascular |Novartis AG|Last Updated: Jul 21, 2026

Target and mechanism

ModalitySmall molecule

Also known as LTP

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment232

FDA Designations

No designations recorded

Clinical trial landscape

LTP001 · 1 trial · 1 indication

Phase 1 1
NCT06649110A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)Healthy Volunteers, Pulmonary Arterial Hypertension
RECRUITING232 Analytics
PHASE1RECRUITING
A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
Healthy Volunteers, Pulmonary Arterial Hypertension
NCT06649110232
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Study Endpoints

Primary Endpoints

Part A- Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Baseline to Day 35

Safety endpoints, including vital signs, ECG, clinical laboratory evaluations and adverse events up to and including the end-of-study visit.

Part B-Treatment Period 1: Change in pulmonary vascular resistance (PVR)
Baseline to Week 24

PVR is a hemodynamic variable of pulmonary circulation and is measured by right heart catheterization.

Part B-Treatment Period 2: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
From Day 1 until Week 106

Safety endpoints, including vital signs, ECG, clinical laboratory evaluations, treatment-emergent adverse events and discontinuations due to adverse events.

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LTP001 Dose 1EXPERIMENTAL -
LTP001 Dose 2EXPERIMENTAL -
LTP001 Dose 3EXPERIMENTAL -
PlaceboPLACEBO_COMPARATORmatching placebo

Interventions

NameTypeDescription
LTPDRUGLTP001
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 100 Years
SexALL
Healthy VolunteersYes
Study Sites87

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, o...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCzechiaFranceGermanyGreeceItalyLatviaMexicoPolandPortugalRomaniaSerbiaSpainUnited Kingdom
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Recent Changes (Last 90 Days)

LOWJul 21, 2026NCT06649110lastUpdatePostDate: changed