Loading clinical trials...

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

ACTIVE_NOT_RECRUITINGPHASE2

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

A Phase 2a Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease

NCT05612035•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Age

40 - 85 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.
+7 more criteria

Locations (84)

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

Key Dates

Start Date

March 16, 2023

Primary Completion Date

April 7, 2026

Completion Date

October 7, 2029

Last Updated

October 7, 2025

Enrollment

120

ESTIMATED participants

Conditions

Pulmonary HypertensionChronic Obstructive Pulmonary Disease

Interventions

Frespaciguat

DRUG

Placebo

DRUG

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

View study

RECRUITINGPHASE1/PHASE2

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

View study

RECRUITINGPHASE1

Preliminary Human Trials of F230 Tablets

NCT06899815

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

cfMSC Stem Cell Therapy Targeting COPD

Preliminary Human Trials of F230 Tablets

Sildinafil in Pulmonary Hypertension-Rheumatic Chronic Valvular Disease(RCT)

Prospective Evaluation of AI-ECG for SHD Detection

Pulmonary Hypertension in Left Heart Disease