Frespaciguat (MK-5475) INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of Frespaciguat (an Inhaled sGC Stimulator) in Adults With PH-COPD
NCT ID: NCT05612035
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2023-03-16
2029-10-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Frespaciguat
Participants with PH-COPD will receive 380 µg of frespaciguat as an oral inhalation once daily for 24 weeks (base period) and thereafter for up to 42 months (optional extension period).
Frespaciguat
Frespaciguat 380 µg administered as dry powder inhalation once daily.
Placebo
Participants with PH-COPD will receive matching placebo as an oral inhalation once daily for 24 weeks (base period) and then 380 µg of frespaciguat as an oral inhalation once daily for up to 42 months (optional extension period).
Frespaciguat
Frespaciguat 380 µg administered as dry powder inhalation once daily.
Placebo
Placebo administered as dry powder inhalation once daily.
Interventions
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Frespaciguat
Frespaciguat 380 µg administered as dry powder inhalation once daily.
Placebo
Placebo administered as dry powder inhalation once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
40 Years
85 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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UCSF Helen Diller Medical Center at Parnassus Heights ( Site 0110)
San Francisco, California, United States
University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 0101)
Aurora, Colorado, United States
Clinovation Intl. Corp. ( Site 0108)
Sebring, Florida, United States
Alexian Brothers Medical Center-Pulmonary ( Site 0109)
Elk Grove Village, Illinois, United States
University of Iowa ( Site 0103)
Iowa City, Iowa, United States
University of Kansas Medical Center-IM-Pulmonary and Critical Care Medicine ( Site 0102)
Kansas City, Kansas, United States
Lexington VA Medical Center - Cooper Division ( Site 0137)
Lexington, Kentucky, United States
Corewell Health ( Site 0133)
Grand Rapids, Michigan, United States
Mayo Clinic in Rochester, Minnesota ( Site 0131)
Rochester, Minnesota, United States
Creighton University Clinical Research Office ( Site 0123)
Omaha, Nebraska, United States
University of New Mexico Hospital ( Site 0146)
Albuquerque, New Mexico, United States
UNC Health - Eastowne Medical Office-Clinical Trials Unit ( Site 0147)
Chapel Hill, North Carolina, United States
Temple University Hospital ( Site 0104)
Philadelphia, Pennsylvania, United States
UPMC Montefiore University Hospital-Department of Medicine ( Site 0149)
Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center ( Site 0114)
Dallas, Texas, United States
The University of Texas Health Science Center at Houston ( Site 0105)
Houston, Texas, United States
Intermountain Medical Center-Division of Pulmonary & Critical Care Medicine ( Site 0140)
Murray, Utah, United States
University of Virginia Health System-Division of Pulmonary and Critical Care Medicine ( Site 0111)
Charlottesville, Virginia, United States
Fundación Respirar ( Site 0305)
CABA, Buenos Aires, Argentina
Centro Medico Capital ( Site 0301)
La Plata, Buenos Aires, Argentina
Instituto de Cardiologia de Tucuman-Area de Investigacion Clinica ( Site 0303)
San Miguel de Tucumán, Tucumán Province, Argentina
Hospital Britanico de Buenos Aires ( Site 0307)
CABA, , Argentina
Hospital Privado Universitario de Córdoba-Clinical Cardiology Department ( Site 0302)
Córdoba, , Argentina
Royal Prince Alfred Hospital-Department of Respiratory Medicine ( Site 0903)
Camperdown, New South Wales, Australia
Westmead Hospital ( Site 0902)
Westmead, New South Wales, Australia
WESLEY RESEARCH INSTITUTE Limited ( Site 0906)
Auchenflower, Queensland, Australia
The Prince Charles Hospital ( Site 0904)
Brisbane, Queensland, Australia
Mater Misericordiae Limited ( Site 0905)
South Brisbane, Queensland, Australia
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1201)
Graz, Styria, Austria
Medizinische Universitaet Innsbruck ( Site 1202)
Innsbruck, Tyrol, Austria
Université Libre de Bruxelles - Hôpital Erasme ( Site 1302)
Brussels, Bruxelles-Capitale, Region de, Belgium
UZ Leuven ( Site 1301)
Leuven, Vlaams-Brabant, Belgium
Clinica Cardio VID ( Site 0504)
Medellín, Antioquia, Colombia
Ciensalud Ips S A S ( Site 0508)
Barranquilla, Atlántico, Colombia
Fundación Valle del Lili ( Site 0509)
Cali, Valle del Cauca Department, Colombia
Centro de Investigaciones Clinicas SAS ( Site 0505)
Cali, Valle del Cauca Department, Colombia
C.H.U Hôpital Nord ( Site 1503)
Marseille, Bouches-du-Rhone, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1502)
Vandœuvre-lès-Nancy, Lorraine, France
CHU Angers ( Site 1506)
Angers, Maine-et-Loire, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1501)
Le Kremlin-Bicêtre, Paris, France
Centre Hospitalier Universitaire de Poitiers ( Site 1505)
Poitiers, Vienne, France
Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 1603)
Heidelberg, Baden-Wurttemberg, Germany
UKGM Gießen/Marburg ( Site 1604)
Giessen, Hesse, Germany
Medizinische Hochschule Hannover ( Site 1602)
Hanover, Lower Saxony, Germany
Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1601)
Dresden, Saxony, Germany
Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 1605)
Lübeck, Schleswig-Holstein, Germany
Unidad De Diagnostico Cardiologico-Unidad de Diagnostico Cardiologico ( Site 0605)
Guatemala City, , Guatemala
MEDI-K ( Site 0607)
Guatemala City, , Guatemala
Clinica Medica ( Site 0601)
Guatemala City, , Guatemala
Private Practice - Dr. Jeremias Guerra Mejia ( Site 0603)
Guatemala City, , Guatemala
Rambam Health Care Campus ( Site 1701)
Haifa, , Israel
Rabin Medical Center ( Site 1702)
Petah Tikva, , Israel
Cattinara Hospital ( Site 1801)
Trieste, Friuli Venezia Giulia, Italy
Ospedale San Gerardo-ASST Monza-Cardio Vasolare- Clinica pneumologica ( Site 1802)
Monza, Lombardy, Italy
ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ( Site 1804)
Palermo, , Italy
Centro Médico Nacional Siglo XXI ( Site 0708)
Mexico City, Mexico City, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0704)
Mexico City, Mexico City, Mexico
INVECORDIS S.C. ( Site 0703)
Hacienda de Las Palmas, State of Mexico, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez ( Site 0701)
México, , Mexico
Unidad de Investigacon de la Clinica Internacional ( Site 0804)
Lima Cercado, Lima region, Peru
Clinica Ricardo Palma-Centro de Investigacion de Enfermedades Respiratorias Thorax ( Site 0806)
San Isidro, Lima region, Peru
Clínica Providencia ( Site 0803)
San Miguel, Lima region, Peru
Charlotte Maxeke Johannesburg Academic Hospital ( Site 2108)
Johannesburg, Gauteng, South Africa
Netcare Milpark Hospital ( Site 2103)
Johannesburg, Gauteng, South Africa
Netcare St Augustine's Hospital ( Site 2105)
Durban, KwaZulu-Natal, South Africa
TREAD Research ( Site 2101)
Cape Town, Western Cape, South Africa
Gachon University Gil Medical Center ( Site 1101)
Namdong-gu, Incheon, South Korea
Seoul National University Hospital ( Site 1103)
Seoul, , South Korea
Asan Medical Center ( Site 1102)
Seoul, , South Korea
Samsung Medical Center ( Site 1104)
Seoul, , South Korea
Hospital Universitario Marqués de Valdecilla-Pneumology ( Site 2003)
Santander, Cantabria, Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 2001)
Barcelona, Catalonia, Spain
Parc de Salut Mar - Hospital del Mar ( Site 2006)
Barcelona, , Spain
Hospital Universitari Vall d'Hebron ( Site 2002)
Barcelona, , Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2005)
Seville, , Spain
University Hospital Basel ( Site 2205)
Basel, Canton of Basel-City, Switzerland
UniversitätsSpital Zürich ( Site 2201)
Zurich, Canton of Zurich, Switzerland
Cantonal Hospital St.Gallen ( Site 2203)
Sankt Gallen, , Switzerland
Hacettepe Universite Hastaneleri ( Site 2301)
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi. ( Site 2307)
Ankara, , Turkey (Türkiye)
Eskisehir Osmangazi University-Cardiology ( Site 2304)
Eskişehir, , Turkey (Türkiye)
Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi-Chest Disease ( Site 2302)
Istanbul, , Turkey (Türkiye)
Hammersmith Hospital-Department of Cardiology ( Site 2401)
London, London, City of, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust-Clinical Research Facility ( Site 2405)
Sheffield, , United Kingdom
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-5475-013
Identifier Type: OTHER
Identifier Source: secondary_id
2022-501201-13-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1279-8512
Identifier Type: REGISTRY
Identifier Source: secondary_id
5475-013
Identifier Type: -
Identifier Source: org_study_id
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