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New inhaled drug aims to ease lung scarring and heart strain

NCT ID NCT06635850

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This Phase 2 trial tests an inhaled medication called mosliciguat in 135 people who have both lung scarring (interstitial lung disease) and high blood pressure in the lungs. Participants are randomly assigned to receive either the drug or a placebo for 16 weeks. The study measures changes in blood vessel resistance in the lungs and how far people can walk in six minutes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mosliciguat (inhaled)
What this could lead to
If successful, this could lead to a new inhaled treatment to improve blood flow and exercise ability in people with lung scarring and high blood pressure in the lungs.
What could go wrong
This is an early Phase 2 trial with only 135 people, so results may not confirm benefit. The drug may cause side effects or not work better than placebo.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

135 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Jan 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 85 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants willing and able to provide informed consent * Participants with diagnosis of Interstitial Lung Disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed diseases include one of the following: 1. Idiopathic interstitial pneumonia (IIP) 2. Chronic hypersensitivity pneumonitis 3. ILD associated with connective tissue disease (CTD) with a forced vital capacity (FVC) \< 70% of predicted * Confirmed pulmonary hypertension (PH) by right heart catheterization (RHC). * Ability to perform 6MWT ≥100 meters. Exclusion Criteria: * Diagnosis of WHO PH Group 1 (eg. pulmonary arterial hypertension), Group 2 (related to left-heart dysfunction), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified). * Exacerbation of underlying lung disease requiring augmentation of therapy or emergent hospitalization within 28 days prior to randomization. * Initiation of pulmonary rehabilitation within 28 days prior to randomization. * Receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline. * History or intolerance to or lack of efficacy with mosliciguat or sGC stimulators or activators. * Receipt of investigational, or experimental therapy within 42 days OR 5 half-lives prior to randomization. Note: Other inclusion and exclusion criteria may apply.

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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

  • Clinical Research Site

    Phoenix, Arizona, 85012, United States

  • Clinical Research Site

    Los Angeles, California, 90024, United States

  • Clinical Research Site

    Sacramento, California, 95817, United States

  • Clinical Research Site

    Santa Barbara, California, 93105, United States

  • Clinical Research Site

    Torrance, California, 90502, United States

  • Clinical Research Site

    Washington D.C., District of Columbia, 20037, United States

  • Clinical Research Site

    Celebration, Florida, 34746, United States

  • Clinical Research Site

    Chicago, Illinois, 60026, United States

  • Clinical Research Site

    Iowa City, Iowa, 52242, United States

  • Clinical Research Site

    Kansas City, Kansas, 66160, United States

  • Clinical Research Site

    Louisville, Kentucky, 40202, United States

  • Clinical Research Site

    Boston, Massachusetts, 02111, United States

  • Clinical Research Site

    Boston, Massachusetts, 02115, United States

  • Clinical Research Site

    New York, New York, 10016, United States

  • Clinical Research Site

    New York, New York, 10029, United States

  • Clinical Research Site

    Durham, North Carolina, 27710, United States

  • Clinical Research Site

    Greensboro, North Carolina, 27403, United States

  • Clinical Research Site

    Cincinnati, Ohio, 45267, United States

  • Clinical Research Site

    Bend, Oregon, 97701, United States

  • Clinical Research Site

    Philadelphia, Pennsylvania, 19140, United States

  • Clinical Research Site

    East Providence, Rhode Island, 02915, United States

  • Clinical Research Site

    Charleston, South Carolina, 29425, United States

  • Clinical Research Site

    Dallas, Texas, 75390, United States

  • Clinical Research Site

    Houston, Texas, 77030, United States

  • Clinical Research Site

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

  • Clinical Research Site

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1426, Argentina

  • Clinical Research Site

    Santa Fe, S3000EOZ, Argentina

  • Clinical Research Site

    Sydney, New South Wales, 2050, Australia

  • Clinical Research Site

    Westmead, New South Wales, 2145, Australia

  • Clinical Research Site

    Auchenflower, Queensland, 4066, Australia

  • Clinical Research Site

    Brussels, Brussels Capital, 1070, Belgium

  • Clinical Research Site

    Leuven, Flanders, 3000, Belgium

  • Clinical Research Site

    Porto Alegre, Rio Grande do Sul, 90020090, Brazil

  • Clinical Research Site

    Blumenau, Santa Catarina, 89010-906, Brazil

  • Clinical Research Site

    São Paulo, 04024-002, Brazil

  • Clinical Research Site

    São Paulo, 05403-904, Brazil

  • Clinical Research Site

    Calgary, Alberta, T1Y 6J4, Canada

  • Clinical Research Site

    London, Ontario, N6A 5W9, Canada

  • Clinical Research Site

    Toronto, Ontario, M5G 2C4, Canada

  • Clinical Research Site

    Prague, Prague, 128 08, Czechia

  • Clinical Research Site

    Prague, Prague, 140 59, Czechia

  • Clinical Research Site

    Bron, Auvergne-Rhône-Alpes, 69677, France

  • Clinical Research Site

    Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, 42270, France

  • Clinical Research Site

    Strasbourg, Bas-Rhin, 67091, France

  • Clinical Research Site

    Le Kremlin-Bicêtre, Île-de-France Region, 94270, France

  • Clinical Research Site

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • Clinical Research Site

    München, Bavaria, 81377, Germany

  • Clinical Research Site

    Dresden, Saxony, 01307, Germany

  • Clinical Research Site

    Halle, Saxony-Anhalt, 06120, Germany

  • Clinical Research Site

    Genova, Genoa, 16132, Italy

  • Clinical Research Site

    Pavia, Lombardy, 27100, Italy

  • Clinical Research Site

    Naples, 80131, Italy

  • Clinical Research Site

    Palermo, 90127, Italy

  • Clinical Research Site

    Roma, 00161, Italy

  • Clinical Research Site

    Narashino, Chiba, 2758580, Japan

  • Clinical Research Site

    Sapporo, Hokkaido, 060-8648, Japan

  • Clinical Research Site

    Kobe, Hyōgo, 650-0017, Japan

  • Clinical Research Site

    Yokohama, Kanagawa, 236-0051, Japan

  • Clinical Research Site

    Okayama, Okayama-ken, 701-1192, Japan

  • Clinical Research Site

    Suita, Osaka, 564-8565, Japan

  • Clinical Research Site

    Chiyoda City, Tokyo, 102-0071, Japan

  • Clinical Research Site

    Riga, 1002, Latvia

  • Clinical Research Site

    Mexico City, Mexico City, 14080, Mexico

  • Clinical Research Site

    Nijmegen, Gelderland, 6500 HB, Netherlands

  • Clinical Research Site

    Amsterdam, North Holland, 1081 HV, Netherlands

  • Clinical Research Site

    Christchurch, Canterbury, 8041, New Zealand

  • Clinical Research Site

    Hamilton, Waikato Region, 3240, New Zealand

  • Clinical Research Site

    Poznan, Greater Poland Voivodeship, 61 848, Poland

  • Clinical Research Site

    Lodz, Lódzkie, 91-347, Poland

  • Clinical Research Site

    Otwock, Masovian Voivodeship, 05-400, Poland

  • Clinical Research Site

    Incheon, Incheon Gwang'yeogsi [Inch'on-Kwangyokshi], 21565, South Korea

  • Clinical Research Site

    Dongjak, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 7061, South Korea

  • Clinical Research Site

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 06351, South Korea

  • Clinical Research Site

    Seoul, Seoul-Teukbyeolsi, 05505, South Korea

  • Clinical Research Site

    Santander, Cantabria, 39008, Spain

  • Clinical Research Site

    Marbella, Málaga, 29603, Spain

  • Clinical Research Site

    Madrid, 28041, Spain

  • Clinical Research Site

    Toledo, 45007, Spain

  • Clinical Research Site

    Pendik, Istanbul, 34899, Turkey (Türkiye)

  • Clinical Research Site

    Bornova, İzmir, 35100, Turkey (Türkiye)

  • Clinical Research Site

    Cambridge, England, CB2 0AY, United Kingdom

  • Clinical Research Site

    London, England, NW3 2QG, United Kingdom

  • Clinical Research Site

    London, England, SW3 6NP, United Kingdom

  • Clinical Research Site

    London, England, W12 0HS, United Kingdom

  • Clinical Research Site

    Clydebank, Scotland, G81 4DY, United Kingdom

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