Study

Overview

Official Title: 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

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.

Study Type:

Interventional

Study Phase:

Phase 2

Estimated Enrollment:

120

Study Start Date:

March 2023

Estimated Study Completion Date:

March 2028

Estimated Primary Completion Date:

April 2026

Eligibility

Ages Eligible for Study:

40 years to 85 years

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

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.

Locations

United States Toll Free Number 1-800-770-4674

Aurora, Colorado, 80045
Elk Grove Village, Illinois, 60007
Iowa City, Iowa, 52242
Kansas City, Kansas, 66160
Lexington, Kentucky, 40502
Grand Rapids, Michigan, 49503
Rochester, Minnesota, 55905
Philadelphia, Pennsylvania, 19140
Dallas, Texas, 75390
HOUSTON, Texas, 77030
Murray, Utah, 84107
Charlottesville, Virginia, 22908

Results

No Study Results Posted

Plain Language Summaries

Protocols

Protocol Plain Language Summary - MK-5475-013
Protocol Plain Language Summary - MK-5475-013-02

Study Detail

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