NCT05135000

Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension

A Randomized, Participant- and Investigator-blinded, Placebo-controlled Study to Investigate Efficacy, Safety, and Tolerability of LTP001 in Participants With Pulmonary Arterial Hypertension

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to explore the efficacy and safety of LTP001 in participants with pulmonary arterial hypertension (PAH) to determine if LTP001 had an adequate clinical profile to warrant further clinical development in this indication.

Detailed description

This study was a non-confirmatory, randomized, participant- and investigator-blinded, placebo controlled trial evaluating the efficacy and safety of LTP001 on top of standard of care in participants with PAH. The study included a screening period of up to 8 weeks, followed by a 24-week treatment phase with daily dosing and visits scheduled approximately every 4 weeks. One follow-up visit, which also served as the end-of-study visit, was conducted approximately 30 days after the conclusion of the treatment phase. The total duration of the study, from the beginning of the screening period to the end-of-study visit, was approximately 37 weeks. A total of 44 participants were planned to be randomized in a 3:1 ratio to receive either LTP001 6 mg or placebo.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	LTP001	LTP001, 6 mg, was administered orally once daily in the morning
DRUG	Placebo	Placebo to LTP001 was administered once daily in the morning

Timeline

• Start date: 2022-06-30
• Primary completion: 2024-03-20
• Completion: 2024-04-25
• First posted: 2021-11-26
• Last updated: 2026-01-13
• Results posted: 2025-05-15

Locations

15 sites across 7 countries: United States, Argentina, Germany, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study