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Clinical Trials in the UK / NCT05612035
Active, not recruiting Phase 2

Frespaciguat (MK-5475) INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of Frespaciguat (an Inhaled sGC Stimulator) in Adults With PH-COPD

NCT05612035 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 2
Started
2023-03-16
Last updated
2026-05-01

Condition(s) studied

Pulmonary HypertensionChronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

FrespaciguatPlacebo

Frespaciguat: Frespaciguat 380 µg administered as dry powder inhalation once daily.

Placebo: Placebo administered as dry powder inhalation once daily.

Study summary

Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic obstructive pulmonary disease (COPD). The goal of the study is to learn if people who take frespaciguat can walk farther in 6 minutes at Week 24 compared to people who take placebo.

Eligibility

Sex
ALL
Min age
40 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (85)

FacilityCityRegionStatus
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 0110) San Francisco California
University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 0101) Aurora Colorado
Clinovation Intl. Corp. ( Site 0108) Sebring Florida
Alexian Brothers Medical Center-Pulmonary ( Site 0109) Elk Grove Village Illinois
University of Iowa ( Site 0103) Iowa City Iowa
University of Kansas Medical Center-IM-Pulmonary and Critical Care Medicine ( Site 0102) Kansas City Kansas
Lexington VA Medical Center - Cooper Division ( Site 0137) Lexington Kentucky
Corewell Health ( Site 0133) Grand Rapids Michigan
Mayo Clinic in Rochester, Minnesota ( Site 0131) Rochester Minnesota
Creighton University Clinical Research Office ( Site 0123) Omaha Nebraska
University of New Mexico Hospital ( Site 0146) Albuquerque New Mexico
UNC Health - Eastowne Medical Office-Clinical Trials Unit ( Site 0147) Chapel Hill North Carolina
Temple University Hospital ( Site 0104) Philadelphia Pennsylvania
UPMC Montefiore University Hospital-Department of Medicine ( Site 0149) Pittsburgh Pennsylvania
UT Southwestern Medical Center ( Site 0114) Dallas Texas
The University of Texas Health Science Center at Houston ( Site 0105) Houston Texas
Intermountain Medical Center-Division of Pulmonary & Critical Care Medicine ( Site 0140) Murray Utah
University of Virginia Health System-Division of Pulmonary and Critical Care Medicine ( Site 0111) Charlottesville Virginia
Fundación Respirar ( Site 0305) CABA Buenos Aires
Centro Medico Capital ( Site 0301) La Plata Buenos Aires
Instituto de Cardiologia de Tucuman-Area de Investigacion Clinica ( Site 0303) San Miguel de Tucumán Tucumán Province
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
Westmead Hospital ( Site 0902) Westmead New South Wales
WESLEY RESEARCH INSTITUTE Limited ( Site 0906) Auchenflower Queensland
The Prince Charles Hospital ( Site 0904) Brisbane Queensland
Mater Misericordiae Limited ( Site 0905) South Brisbane Queensland
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1201) Graz Styria
Medizinische Universitaet Innsbruck ( Site 1202) Innsbruck Tyrol
Université Libre de Bruxelles - Hôpital Erasme ( Site 1302) Brussels Bruxelles-Capitale, Region de
UZ Leuven ( Site 1301) Leuven Vlaams-Brabant
Clinica Cardio VID ( Site 0504) Medellín Antioquia
Ciensalud Ips S A S ( Site 0508) Barranquilla Atlántico
Fundación Valle del Lili ( Site 0509) Cali Valle del Cauca Department
Centro de Investigaciones Clinicas SAS ( Site 0505) Cali Valle del Cauca Department
C.H.U Hôpital Nord ( Site 1503) Marseille Bouches-du-Rhone
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1502) Vandœuvre-lès-Nancy Lorraine
CHU Angers ( Site 1506) Angers Maine-et-Loire
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1501) Le Kremlin-Bicêtre Paris

+ 45 more sites — see the full list on the official registry below.

More Merck Sharp & Dohme LLC trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05612035 on ClinicalTrials.gov ↗ ← All trials in the UK