Experimental PAH drug trial halted early
NCT ID NCT05135000
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested an experimental drug called LTP001 in 47 people with pulmonary arterial hypertension (PAH), a condition where high blood pressure damages the arteries in the lungs. The goal was to see if LTP001 could improve blood flow and exercise ability. However, the trial was terminated early, meaning it likely did not show enough promise to continue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LTP001 (an experimental oral drug)
- What this could lead to
- If it had worked, LTP001 could have pointed toward a new treatment option for pulmonary arterial hypertension, a serious lung condition.
- What could go wrong
- The trial was terminated early, meaning it likely did not show enough benefit or had safety concerns. It was also a small Phase 2 study, so results are very preliminary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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47 people
The number who actually took part.
- Started
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Jun 2022
- Finished
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Apr 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * History of PAH belonging to one of the following subgroups of the Clinical Classification Group 1 (WHO): * participants with idiopathic pulmonary arterial hypertension (IPAH) * Hereditary pulmonary arterial hypertension * Congenital heart disease (surgically repaired at least 12 months prior to screening) * drug or toxin induced (for example, anorexigen, or methamphetamine use). * Resting mean pulmonary arterial pressure (mPAP) \> 25 mmHg; pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure \< 15 mmHg, as determined by right heart catheterization within 20 days of randomization. * Pulmonary Vascular Resistance \> 6 Wood units (480 dynes s/cm-5), as determined by right heart catheterization within 20 days of randomization. * WHO Functional Class II-III * 6MWD must be between 150 and 550 m (inclusive). The qualifying test needs to be within 20 days of randomization. To meet the above criterion additional six minute walk test (6MWT) may be performed up to a maximum of 3 tests in total prior to dosing; the minimal time difference between two tests should be at least 4 h. * Standard of care therapy which is stable at least 6 weeks prior to RHC and qualifying 6MWT assessment within 20 days of randomization. Standard of care includes one or more of the following treatments: * prostacyclin analogues and receptor agonists (if I.V., dose adjustments must be within 20% of initial stable dose) * endothelin receptor antagonists (ERAs) * phosphodiesterase type 5 inhibitors (PDE5i) * soluble guanylate cyclase (sGC) stimulators Exclusion Criteria: * Participants with pulmonary hypertension (PH) in the Clinical Classification Groups 2-5 (WHO), and any PAH Group 1 subgroups not covered by Inclusion Criterion #4. * Participants with a history of left sided heart disease, chronic left sided heart failure, congenital or acquired valvular disease compromising left ventricular function and/or pulmonary venous hypertension or symptomatic coronary disease (non-symptomatic, revascularized coronary artery disease would be acceptable). * Participants with obstructive lung disease defined as: FEV1/FVC \< 60% and FEV1 \< 60% of predicted value after bronchodilator administration as well as participants with moderate or severe restrictive lung disease: Total Lung Capacity \< 70% of predicted value. Testing must have occurred within 24months of screening. If historical testing is not available, then lung function testing must be conducted during the screening period. * Acute or chronic impairment (other than dyspnea), which would limit the ability to comply with study requirements, including interference with physical activity and execution of study procedures such as 6MWT (e.g., angina pectoris, claudication, musculoskeletal disorder, multiple sclerosis, need for walking aids).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Medical Univ of South Carolina
Charleston, South Carolina, 29425, United States
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Novartis Investigative Site
Caba, Buenos Aires, C1025ABI, Argentina
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Novartis Investigative Site
Berlin, 13353, Germany
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Novartis Investigative Site
Dresden, 01307, Germany
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Novartis Investigative Site
Heidelberg, 69120, Germany
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Novartis Investigative Site
Amsterdam, 1081 HV, Netherlands
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Novartis Investigative Site
Krakow, 31 202, Poland
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Novartis Investigative Site
Lodz, 91-347, Poland
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Novartis Investigative Site
Wroclaw, 50-556, Poland
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Novartis Investigative Site
Málaga, Andalusia, 29010, Spain
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Novartis Investigative Site
Barcelona, Catalonia, 08036, Spain
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Novartis Investigative Site
Madrid, 28041, Spain
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Novartis Investigative Site
Sheffield, South Yorkshire, S10 2JF, United Kingdom
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Novartis Investigative Site
London, SW3 6PH, United Kingdom
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Pulmonary Associates PA
Mesa, Arizona, 85206, United States
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