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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID: NCT05612035
Run by: Merck Sharp & Dohme LLC
People needed: 129
Starts: 2023-03-16
Expected to finish: 2029-10-08
Last updated by the study team: 2026-05-01

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

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
Cattinara Hospital ( Site 1801) — Trieste, Friuli Venezia Giulia, Italy
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
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 0110) — San Francisco, California, United States

Full record on ClinicalTrials.gov

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