A Study of LTP001 for Pulmonary Arterial Hypertension
This study is testing a treatment called LTP001. It has two parts. Part A is for healthy volunteers to learn about the safety and how LTP001 moves through the body. Part B is for people with pulmonary arterial hypertension (PAH), a condition where blood pressure in the arteries of the lungs is too high. In Part B, researchers will look at the safety and how well LTP001 works compared to a placebo (an inactive substance). The study aims to see if LTP001 can improve pulmonary vascular resistance (PVR), which is a measure of blood flow through the lungs. You can join if you are between 18 and 100 years old. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 232 participants. It involves comparing LTP001 to a placebo.
- What's involved
- Participants in Part A will be monitored for adverse events for 35 days. Participants in Part B will have their pulmonary vascular resistance measured for 24 weeks and be monitored for adverse events for up to 106 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants in Part A will be followed for 35 days. Participants in Part B will be followed for up to 106 weeks after treatment begins.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
At a glance
Conditions
NCT06649110
Where you'd take part
This study runs at 87 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Arizona Pulmonary Specialists Ltd
Scottsdale, Arizonastudy coordinator listed
Recruiting
Central Florida Pulmonary Group
Orlando, Floridastudy coordinator listed
Recruiting
Emory University School of Medicine
Atlanta, Georgiastudy coordinator listed
Recruiting
Lahey Hospital and Medical Center
Burlington, Massachusettsstudy coordinator listed
Recruiting
Norton Infectious Diseases Specialists
Louisville, Kentuckystudy coordinator listed
Recruiting
PPD Development LP
Austin, Texasstudy coordinator listed
Recruiting
Pul Ass Richmond Inc P A R
Richmond, Virginiastudy coordinator listed
Recruiting
Stanford Medical Center
Stanford, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
What this trial measures
- 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.