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Exploring the treatment LTP001 in healthy individuals and those with pulmonary arterial hypertension

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)

Phase1; Phase2 Interventional Novartis · NCT06649110

This study is testing a new treatment called LTP001 in healthy people and those with pulmonary arterial hypertension to see how safe it is and if it can help improve their condition.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment232 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Locations85 sites (Scottsdale, Arizona and 84 other locations)
Trial IDNCT06649110 on ClinicalTrials.gov

What this trial studies

This study investigates the safety, tolerability, and pharmacokinetics of LTP001 in healthy volunteers in Part A, while Part B focuses on participants diagnosed with pulmonary arterial hypertension (PAH). The study aims to evaluate both the safety and efficacy of LTP001 in individuals with PAH, who are already receiving standard treatments. Participants will undergo assessments to determine the drug's effects on their condition and overall health. The study is designed to provide insights into how LTP001 can be used in treating PAH.

Who should consider this trial

Good fit: Ideal candidates include healthy males and non-child-bearing potential females for Part A, and individuals with a confirmed diagnosis of PAH for Part B.

Not a fit: Patients with significant cardiac abnormalities or those with conditions that could jeopardize their safety during the study may not benefit.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from pulmonary arterial hypertension.

How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in evaluating new treatments for PAH.

Eligibility criteria

Show full inclusion / exclusion criteria 
Part A Inclusion Criteria:

* Healthy males and non-child-bearing potential females

Part A Exclusion Criteria:

* Clinically significant ECG or cardiac abnormalities, any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the participant in the study Other protocol-defined inclusion/exclusion criteria may apply.
* For Japanese cohorts: participants per protocol should be first generation Japanese or up to third generation Japanese as defined in inclusion criteria 7 of the protocol.

Part B Inclusion Criteria:

-Confirmed diagnosis of PAH, pre-randomization PVR ≥400 dyn.sec.cm-5, treatment with stable doses of standard-of-care PAH therapies, 6-minute walk distance ≥ 150 m and ≤450 m.

Part B Exclusion Criteria:

Any surgical or medical condition which may place the participant at higher risk from his/her participation in the study Women of child-bearing potential unless they are using highly effective methods of contraception Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 24 hours after stopping study treatment.

History of hypersensitivity to any of the study treatments or excipients

Other protocol-defined inclusion / exclusion criteria may apply

Where this trial is running

Scottsdale, Arizona and 84 other locations

+35 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Healthy Volunteers, Pulmonary Arterial HypertensionLTP001pulmonary arterial hypertensionPAHPVR
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.