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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)

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513613-12-00
Acronym
CLTP001A12202
Enrollment
68
Registered
2025-08-25
Start date
2025-09-18
Completion date
Unknown
Last updated
2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Part A: Healthy volunteers (Part A is not applicable to the EU; for information only) Part B: pulmonary arterial hypertension

Brief summary

Part A: All safety endpoints, including vital signs, ECG, central lab evaluations and AEs up to and including the EoS visit. Part B: (Period 1) Change in PVR from baseline to 24 weeks (Period 2): All safety endpoints, including vital signs, ECG, central lab evaluations, treatment-emergent AEs and discontinuations due to AEs.

Detailed description

Part A: Cmax, Tmax, AUClast, AUCinf and T1/2 of LTP001 Part B: (Period 1) Change in 6MWD from baseline to 24 weeks. (Period 2) Change in 6MWD from baseline to 18 months, Part B Period 2: Number of participants experiencing an improvement in WHO FC from baseline to 18 months, Part B (Period 1): Change in WHO FC from baseline to 24 weeks, Part B (Period 1): All safety endpoints, including vital signs, ECG, clinical laboratory evaluations, treatment-emergent adverse events and discontinuations due to adverse events

Interventions

DRUGPlacebo to LTP001 00mg hard gelatin capsule
DRUGLTP001

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part A: All safety endpoints, including vital signs, ECG, central lab evaluations and AEs up to and including the EoS visit. Part B: (Period 1) Change in PVR from baseline to 24 weeks (Period 2): All safety endpoints, including vital signs, ECG, central lab evaluations, treatment-emergent AEs and discontinuations due to AEs.

Secondary

MeasureTime frame
Part A: Cmax, Tmax, AUClast, AUCinf and T1/2 of LTP001 Part B: (Period 1) Change in 6MWD from baseline to 24 weeks. (Period 2) Change in 6MWD from baseline to 18 months, Part B Period 2: Number of participants experiencing an improvement in WHO FC from baseline to 18 months, Part B (Period 1): Change in WHO FC from baseline to 24 weeks, Part B (Period 1): All safety endpoints, including vital signs, ECG, clinical laboratory evaluations, treatment-emergent adverse events and discontinuations due to adverse events

Countries

Belgium, Czechia, France, Germany, Greece, Italy, Latvia, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026