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New inhaled drug aims to help COPD patients walk farther

NCT ID NCT05612035

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an inhaled drug called frespaciguat (MK-5475) in 129 adults who have high blood pressure in their lungs caused by COPD. The main goal is to see if the drug helps people walk farther in 6 minutes after 24 weeks compared to a placebo. Participants take one daily inhalation of the drug or a placebo.

What this could mean

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

Active substance
frespaciguat (MK-5475) inhaled daily
What this could lead to
If successful, this could lead to a new inhaled treatment to help people with PH-COPD walk farther and breathe easier.
What could go wrong
This is an early Phase 2 trial with only 129 participants, so results may not apply to everyone. The drug may not improve walking distance or could cause side effects.

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

129 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Oct 2029

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

40 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.

The key inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has Group 3.1 pulmonary hypertension chronic obstructive pulmonary disease (PH-COPD) as defined by the Clinical Classification of Pulmonary Hypertension. * Has a right heart catheterization (RHC) at screening or historical RHC within 12 months before screening that meets hemodynamic criteria. * Has a physician diagnosis of obstructive lung disease on pulmonary function testing (PFT) performed at screening. * Has a WHO Functional Class assessment of Class II to IV. * If on supplemental oxygen, the regimen must be stable. * Has stable and optimized chronic, baseline COPD-specific therapy. * If on PDE5 inhibitor, has stable concomitant use (initiated at least 3 months prior to randomization and no change in drug or dosage for at least 3 months prior to randomization) and changes to PDE5 inhibitor dosing is not anticipated during the 24 week Base Period. * If on antihypertensives and/or a diuretic regimen has stable concomitant use. * If on anticoagulants has stable concomitant use. * Is of any sex/gender from 40 to 85 years of age inclusive. * Female is not pregnant or breastfeeding, and is not of childbearing potential or uses acceptable contraceptive method or abstains from sexual intercourse, or has a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention, or whose history and sexual activity has been reviewed by the investigator. Exclusion criteria: * Has Group 1 pulmonary arterial hypertension (PAH), Groups 2, 4 or 5 pulmonary hypertension (PH). * Has non-COPD related Group 3 PH. * Has evidence of untreated more than mild obstructive sleep apnea. * Has significant left heart disease. * Expects to receive a lung and/or heart transplant from screening through the end of the 24 week Base Period. * Has evidence of a resting oxygen saturation (SpO2) \< 88%. * Has experienced a moderate or severe COPD exacerbation within 2 months before randomization. * Has experienced right heart failure within 2 months before randomization. * Has uncontrolled tachyarrhythmia. * Has acute coronary syndrome, undergone coronary artery bypass graft, or percutaneous coronary intervention within 2 months before randomization. * Has evidence of significant chronic renal insufficiency. * Has evidence of chronic liver disease, portal hypertension, cirrhosis, or hepatic abnormalities. * Initiated a pulmonary rehabilitation program within 2 months before randomization. * Has impairments that limit the ability to perform 6MWT. * Has history of cancer. * Is a user of illicit drugs or has a recent history of drug/alcohol abuse or dependence. * Has used PAH-specific therapies within 2 months of randomization.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease pulmonary hypertension pulmonary hypertension owing to lung disease and/or hypoxia

As listed by the trial registrant

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

Chronic obstructive pulmonary disease Pulmonary hypertension

Contacts and locations

Locations

  • Alexian Brothers Medical Center-Pulmonary ( Site 0109)

    Elk Grove Village, Illinois, 60007, United States

  • Ankara Bilkent Şehir Hastanesi. ( Site 2307)

    Ankara, 06800, Turkey (Türkiye)

  • Ankara University Health Practice and Research Hospitals ( Site 2310)

    Ankara, 6100, Turkey (Türkiye)

  • Asan Medical Center ( Site 1102)

    Seoul, 05505, South Korea

  • C.H.U Hôpital Nord ( Site 1503)

    Marseille, Bouches-du-Rhone, 13915, France

  • CHU Angers ( Site 1506)

    Angers, Maine-et-Loire, 49933, France

  • Cantonal Hospital St.Gallen ( Site 2203)

    Sankt Gallen, 9007, Switzerland

  • Cattinara Hospital ( Site 1801)

    Trieste, Friuli Venezia Giulia, 34149, Italy

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1502)

    Vandœuvre-lès-Nancy, Lorraine, 54511, France

  • Centre Hospitalier Universitaire de Poitiers ( Site 1505)

    Poitiers, Vienne, 86021, France

  • Centro Medico Capital ( Site 0301)

    La Plata, Buenos Aires, 1904, Argentina

  • Centro Médico Nacional Siglo XXI ( Site 0708)

    Mexico City, Mexico City, 06760, Mexico

  • Centro de Investigaciones Clinicas SAS ( Site 0505)

    Cali, Valle del Cauca Department, 760036, Colombia

  • Charlotte Maxeke Johannesburg Academic Hospital ( Site 2108)

    Johannesburg, Gauteng, 2193, South Africa

  • Ciensalud Ips S A S ( Site 0508)

    Barranquilla, Atlántico, 080001, Colombia

  • Clinica Cardio VID ( Site 0504)

    Medellín, Antioquia, 050034, Colombia

  • Clinica Medica ( Site 0601)

    Guatemala City, 01010, Guatemala

  • Clinica Ricardo Palma-Centro de Investigacion de Enfermedades Respiratorias Thorax ( Site 0806)

    San Isidro, Lima region, 15036, Peru

  • Clinovation Intl. Corp. ( Site 0108)

    Sebring, Florida, 33870, United States

  • Clínica Providencia ( Site 0803)

    San Miguel, Lima region, 15088, Peru

  • Corewell Health ( Site 0133)

    Grand Rapids, Michigan, 49546, United States

  • Creighton University Clinical Research Office ( Site 0123)

    Omaha, Nebraska, 68124, United States

  • Eskisehir Osmangazi University-Cardiology ( Site 2304)

    Eskişehir, 26480, Turkey (Türkiye)

  • Fundación Respirar ( Site 0305)

    CABA, Buenos Aires, C1426ABP, Argentina

  • Fundación Valle del Lili ( Site 0509)

    Cali, Valle del Cauca Department, 760032, Colombia

  • Gachon University Gil Medical Center ( Site 1101)

    Namdong-gu, Incheon, 21565, South Korea

  • HOSPITAL CLÍNIC DE BARCELONA ( Site 2001)

    Barcelona, Catalonia, 08036, Spain

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2005)

    Seville, 41013, Spain

  • Hacettepe Universite Hastaneleri ( Site 2301)

    Ankara, 06230, Turkey (Türkiye)

  • Hammersmith Hospital-Department of Cardiology ( Site 2401)

    London, London, City of, W12 OHS, United Kingdom

  • Hospital Britanico de Buenos Aires ( Site 0307)

    CABA, C1280AEB, Argentina

  • Hospital Privado Universitario de Córdoba-Clinical Cardiology Department ( Site 0302)

    Córdoba, X5016KEH, Argentina

  • Hospital Universitari Vall d'Hebron ( Site 2002)

    Barcelona, 08035, Spain

  • Hospital Universitario Marqués de Valdecilla-Pneumology ( Site 2003)

    Santander, Cantabria, 39008, Spain

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1501)

    Le Kremlin-Bicêtre, Paris, 94270, France

  • INVECORDIS S.C. ( Site 0703)

    Hacienda de Las Palmas, State of Mexico, 52787, Mexico

  • ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ( Site 1804)

    Palermo, 90127, Italy

  • Instituto Nacional de Cardiologia Ignacio Chavez ( Site 0701)

    México, 14080, Mexico

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0704)

    Mexico City, Mexico City, 14080, Mexico

  • Instituto de Cardiologia de Tucuman-Area de Investigacion Clinica ( Site 0303)

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Intermountain Medical Center-Division of Pulmonary & Critical Care Medicine ( Site 0140)

    Murray, Utah, 84107, United States

  • Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi-Chest Disease ( Site 2302)

    Istanbul, 34093, Turkey (Türkiye)

  • Lexington VA Medical Center - Cooper Division ( Site 0137)

    Lexington, Kentucky, 40502, United States

  • MEDI-K ( Site 0607)

    Guatemala City, 01009, Guatemala

  • Mater Misericordiae Limited ( Site 0905)

    South Brisbane, Queensland, 4101, Australia

  • Mayo Clinic in Rochester, Minnesota ( Site 0131)

    Rochester, Minnesota, 55905, United States

  • Medizinische Hochschule Hannover ( Site 1602)

    Hanover, Lower Saxony, 30625, Germany

  • Medizinische Universitaet Innsbruck ( Site 1202)

    Innsbruck, Tyrol, 6020, Austria

  • Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1201)

    Graz, Styria, 8036, Austria

  • Netcare Milpark Hospital ( Site 2103)

    Johannesburg, Gauteng, 2193, South Africa

  • Netcare St Augustine's Hospital ( Site 2105)

    Durban, KwaZulu-Natal, 4001, South Africa

  • Ospedale San Gerardo-ASST Monza-Cardio Vasolare- Clinica pneumologica ( Site 1802)

    Monza, Lombardy, 20900, Italy

  • Parc de Salut Mar - Hospital del Mar ( Site 2006)

    Barcelona, 08003, Spain

  • Private Practice - Dr. Jeremias Guerra Mejia ( Site 0603)

    Guatemala City, 01010, Guatemala

  • Rabin Medical Center ( Site 1702)

    Petah Tikva, 4941 492, Israel

  • Rambam Health Care Campus ( Site 1701)

    Haifa, 3109601, Israel

  • Royal Prince Alfred Hospital-Department of Respiratory Medicine ( Site 0903)

    Camperdown, New South Wales, 2050, Australia

  • Samsung Medical Center ( Site 1104)

    Seoul, 06355, South Korea

  • Seoul National University Hospital ( Site 1103)

    Seoul, 03080, South Korea

  • Sheffield Teaching Hospitals NHS Foundation Trust-Clinical Research Facility ( Site 2405)

    Sheffield, S10 2JF, United Kingdom

  • TREAD Research ( Site 2101)

    Cape Town, Western Cape, 7500, South Africa

  • Temple University Hospital ( Site 0104)

    Philadelphia, Pennsylvania, 19140, United States

  • The Prince Charles Hospital ( Site 0904)

    Brisbane, Queensland, 4032, Australia

  • The University of Texas Health Science Center at Houston ( Site 0105)

    Houston, Texas, 77030, United States

  • Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 1603)

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • UCSF Helen Diller Medical Center at Parnassus Heights ( Site 0110)

    San Francisco, California, 94143, United States

  • UKGM Gießen/Marburg ( Site 1604)

    Giessen, Hesse, 35392, Germany

  • UNC Health - Eastowne Medical Office-Clinical Trials Unit ( Site 0147)

    Chapel Hill, North Carolina, 27514, United States

  • UPMC Montefiore University Hospital-Department of Medicine ( Site 0149)

    Pittsburgh, Pennsylvania, 15213, United States

  • UT Southwestern Medical Center ( Site 0114)

    Dallas, Texas, 75390, United States

  • UZ Leuven ( Site 1301)

    Leuven, Vlaams-Brabant, 3000, Belgium

  • Unidad De Diagnostico Cardiologico-Unidad de Diagnostico Cardiologico ( Site 0605)

    Guatemala City, 01001, Guatemala

  • Unidad de Investigacon de la Clinica Internacional ( Site 0804)

    Lima Cercado, Lima region, 15001, Peru

  • Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1601)

    Dresden, Saxony, 01307, Germany

  • University Hospital Basel ( Site 2205)

    Basel, Canton of Basel-City, 4031, Switzerland

  • University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 0101)

    Aurora, Colorado, 80045, United States

  • University of Iowa ( Site 0103)

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center-IM-Pulmonary and Critical Care Medicine ( Site 0102)

    Kansas City, Kansas, 66160, United States

  • University of New Mexico Hospital ( Site 0146)

    Albuquerque, New Mexico, 87106, United States

  • University of Virginia Health System-Division of Pulmonary and Critical Care Medicine ( Site 0111)

    Charlottesville, Virginia, 22908, United States

  • UniversitätsSpital Zürich ( Site 2201)

    Zurich, Canton of Zurich, 8091, Switzerland

  • Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 1605)

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Université Libre de Bruxelles - Hôpital Erasme ( Site 1302)

    Brussels, Bruxelles-Capitale, Region de, 1070, Belgium

  • WESLEY RESEARCH INSTITUTE Limited ( Site 0906)

    Auchenflower, Queensland, 4066, Australia

  • Westmead Hospital ( Site 0902)

    Westmead, New South Wales, 2145, Australia

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