Study of LTP001 to Assess Safety and Effects in Healthy Adults and in Adults With Pulmonary Arterial Hypertension

What this Trial Is About

This research aims to evaluate LTP001 treatment in both healthy adults and participants with pulmonary arterial hypertension PAH. It explores safety, tolerability, and how the body processes LTP001 in healthy volunteers Part A, and assesses safety and efficacy in PAH patients Part B followed by an extended safety period. The study is designed as a randomized, double-blind, placebo-controlled trial sponsored by Novartis Pharmaceuticals. Participants in Part A receive single and multiple ascending doses of LTP001 or placebo to understand pharmacokinetics and safety over 35 days. Part B involves treatment with LTP001 or placebo alongside stable standard PAH therapies, with treatment periods up to 106 weeks including a 24-week initial evaluation and a longer safety extension. Both parts include placebo comparison and dose escalation in a parallel study model. Throughout the study, participants undergo monitoring for adverse events, changes in pulmonary vascular resistance, and functional assessments such as the Six-minute Walk Test and WHO functional class. Blood tests measure biomarkers like NT-proBNP. Safety and pharmacokinetic data are collected frequently in Part A, while Part B includes long-term efficacy and safety evaluations up to 106 weeks. Participant involvement includes regular visits for treatment administration, assessments, and follow-up until study completion in late 2028.

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)