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New drug LTP001 aims to ease rare lung condition

NCT ID NCT06649110

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This study tests an experimental drug called LTP001 for pulmonary arterial hypertension (PAH), a serious lung condition that makes it hard for the heart to pump blood. The trial has two parts: first, healthy volunteers receive single or multiple doses to check safety and how the drug moves through the body. Then, people with PAH receive the drug to see if it improves blood flow in the lungs and is safe. About 232 participants will take part.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 232 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 100 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

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

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers, pulmonary arterial hypertension

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    87 sites in 18 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allegheny General Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15212-4756, United States

  • Arizona Pulmonary Specialists Ltd

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Central Florida Pulmonary Group

    RECRUITING

    Orlando, Florida, 32803-5734, United States

  • Emory University School of Medicine

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Lahey Hospital and Medical Center

    RECRUITING

    Burlington, Massachusetts, 01805, United States

  • Norton Infectious Diseases Specialists

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Novartis Investigative Site

    RECRUITING

    Buenos Aires, Buenos Aires F.D., 1199, Argentina

  • Novartis Investigative Site

    RECRUITING

    CABA, C1426ABP, Argentina

  • Novartis Investigative Site

    RECRUITING

    Río Cuarto, X5800AEV, Argentina

  • Novartis Investigative Site

    RECRUITING

    San Miguel de Tucumán, T4000AXL, Argentina

  • Novartis Investigative Site

    RECRUITING

    Santa Fe, S3000EOZ, Argentina

  • Novartis Investigative Site

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Novartis Investigative Site

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • Novartis Investigative Site

    RECRUITING

    New Lambton Heights, New South Wales, 2305, Australia

  • Novartis Investigative Site

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Novartis Investigative Site

    RECRUITING

    Leuven, Vlaams Brabant, 3000, Belgium

  • Novartis Investigative Site

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

  • Novartis Investigative Site

    RECRUITING

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    RECRUITING

    Prague, 14021, Czechia

  • Novartis Investigative Site

    RECRUITING

    Angers, France, 49933, France

  • Novartis Investigative Site

    RECRUITING

    Brest, 29200, France

  • Novartis Investigative Site

    RECRUITING

    Clamart, 92141, France

  • Novartis Investigative Site

    RECRUITING

    Grenoble, 38043, France

  • Novartis Investigative Site

    RECRUITING

    Montpellier, 34295, France

  • Novartis Investigative Site

    RECRUITING

    Nice, 06001, France

  • Novartis Investigative Site

    RECRUITING

    Pessac, 33604, France

  • Novartis Investigative Site

    RECRUITING

    Poitiers, 86021, France

  • Novartis Investigative Site

    RECRUITING

    Saint-Priest-en-Jarez, 42270, France

  • Novartis Investigative Site

    RECRUITING

    Strasbourg, 67091, France

  • Novartis Investigative Site

    RECRUITING

    Toulouse, 31059, France

  • Novartis Investigative Site

    RECRUITING

    Vandœuvre-lès-Nancy, 54511, France

  • Novartis Investigative Site

    RECRUITING

    Regensburg, Bavaria, 93053, Germany

  • Novartis Investigative Site

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 13125, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 14050, Germany

  • Novartis Investigative Site

    RECRUITING

    Giessen, 35392, Germany

  • Novartis Investigative Site

    RECRUITING

    Greifswald, 17475, Germany

  • Novartis Investigative Site

    RECRUITING

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    RECRUITING

    Homburg, 66421, Germany

  • Novartis Investigative Site

    RECRUITING

    Athens, 106 76, Greece

  • Novartis Investigative Site

    RECRUITING

    Chaïdári, 124 62, Greece

  • Novartis Investigative Site

    RECRUITING

    Thessaloniki, 54636, Greece

  • Novartis Investigative Site

    RECRUITING

    Foggia, FG, 71122, Italy

  • Novartis Investigative Site

    RECRUITING

    Monza, MB, 20900, Italy

  • Novartis Investigative Site

    RECRUITING

    Palermo, PA, 90127, Italy

  • Novartis Investigative Site

    RECRUITING

    Pavia, PV, 27100, Italy

  • Novartis Investigative Site

    RECRUITING

    Roma, RM, 00161, Italy

  • Novartis Investigative Site

    RECRUITING

    Sassari, SS, 07100, Italy

  • Novartis Investigative Site

    RECRUITING

    Ivrea, TO, 10015, Italy

  • Novartis Investigative Site

    RECRUITING

    Trieste, TS, 34149, Italy

  • Novartis Investigative Site

    RECRUITING

    Riga, LV 1002, Latvia

  • Novartis Investigative Site

    RECRUITING

    Monterrey, Nuevo León, 64460, Mexico

  • Novartis Investigative Site

    RECRUITING

    Monterrey, Nuevo León, 64718, Mexico

  • Novartis Investigative Site

    RECRUITING

    San Luis Potosí City, San Luis Potosí, 78200, Mexico

  • Novartis Investigative Site

    RECRUITING

    Poznan, 61 545, Poland

  • Novartis Investigative Site

    RECRUITING

    Almada, 2805-267, Portugal

  • Novartis Investigative Site

    RECRUITING

    Lisbon, 1769 001, Portugal

  • Novartis Investigative Site

    RECRUITING

    Timișoara, Timiș County, 300310, Romania

  • Novartis Investigative Site

    RECRUITING

    Bucharest, 050159, Romania

  • Novartis Investigative Site

    RECRUITING

    Belgrade, Serbia, 11000, Serbia

  • Novartis Investigative Site

    RECRUITING

    Kamenitz, 21204, Serbia

  • Novartis Investigative Site

    RECRUITING

    Niš, 18108, Serbia

  • Novartis Investigative Site

    RECRUITING

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    RECRUITING

    Marbella, Andalusia, 29600, Spain

  • Novartis Investigative Site

    RECRUITING

    Toledo, Castille-La Mancha, 45071, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, Catalonia, 08003, Spain

  • Novartis Investigative Site

    RECRUITING

    Las Palmas de Gran C, Las Palmas, 35016, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    RECRUITING

    Seville, 41013, Spain

  • Novartis Investigative Site

    RECRUITING

    Sheffield, South Yorkshire, S10 2JF, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Cambridge, CB2 0AY, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, EC1A 7BE, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, SW3 6PH, United Kingdom

  • PPD Development LP

    RECRUITING

    Austin, Texas, 78744, United States

  • PPD Development LP

    RECRUITING

    Austin, Texas, 78744, United States

  • Pul Ass Richmond Inc P A R

    RECRUITING

    Richmond, Virginia, 23230-1709, United States

  • Sky Integrative Medical Center SKYCRNG PPDS

    RECRUITING

    Ridgeland, Mississippi, 39157-5179, United States

  • Stanford Medical Center

    RECRUITING

    Stanford, California, 94305, United States

  • Statcare Pulmonary Consultants

    RECRUITING

    Knoxville, Tennessee, 37919, United States

  • Summit Health Eastside Clinic

    RECRUITING

    Bend, Oregon, 97701, United States

  • The University of Utah

    RECRUITING

    Salt Lake City, Utah, 84132-0001, United States

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • U of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • UC Irvine Medical Center

    RECRUITING

    Orange, California, 92868-3298, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Univ Colorado Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606-3475, United States