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

• Status: Not yet recruiting
• Trial end date: 2026-09-15
• Target enrollment: 0
• Participant gender: All

Summary

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 80 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme LLC

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 evidence 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 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 80 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 history of Group 1 pulmonary arterial hypertension (PAH), Groups 2, 4 or 5 pulmonary hypertension (PH).

• Has history of non-COPD related Group 3 PH.

• Has evidence of untreated more than mild obstructive sleep apnea.

• Has evidence or history of 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) < 90%.

• 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.