MK-5475-013 INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of MK-5475 (an Inhaled sGC Stimulator) in Adults With PH-COPD

Study Purpose

The purpose of this study is to evaluate the safety and efficacy of once daily oral inhalation dose of MK-5475 380 µg in participants 40 to 85 years (inclusive) with Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease (PH-COPD). The primary hypothesis of the study is MK-5475, a soluble Guanylate Cyclase (sGC) stimulator is superior to placebo in increasing 6 Minute Walking Distance (6MWD) from baseline at Week 24.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05612035
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Merck Sharp & Dohme LLC
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Medical Director
Principal Investigator Affiliation	Merck Sharp & Dohme LLC
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Austria, Belgium, Colombia, France, Germany, Israel, Italy, Korea, Republic of, Mexico, Peru, South Africa, Spain, Switzerland, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: MK-5475

Participants with PH-COPD will receive 380 µg of MK-5475 as an oral inhalation once daily for 24 weeks (base period) and thereafter for 18 months (optional extension period).

Placebo Comparator: 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 MK-5475 as an oral inhalation once daily for 18 months (optional extension period).

Interventions

Drug: - MK-5475

MK-5475 380 µg administered as dry powder inhalation once daily.

Drug: - Placebo

Placebo administered as dry powder inhalation once daily.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Aurora, Colorado

Status

Recruiting

Address

University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular

Aurora, Colorado, 80045

Site Contact

Study Coordinator

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