NCT06649110

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)

Detailed description

The CLTP001A12202 study will explore the safety, tolerability, and pharmacokinetics of LTP001 in healthy volunteers (Part A) and will evaluate the safety and efficacy (Part B) followed by safety extension in participants with pulmonary arterial hypertension.

Conditions

• Healthy Volunteers, Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	LTP	LTP001
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-10-24
• Primary completion: 2028-11-29
• Completion: 2028-12-31
• First posted: 2024-10-18
• Last updated: 2026-03-09

Locations

29 sites across 12 countries: United States, Australia, Brazil, Czechia, Germany, Greece, Italy, Latvia, Portugal, Romania, Spain, United Kingdom

Regulatory

• FDA-regulated drug study