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

Purpose

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 MK-5475 can walk farther in 6 minutes at Week 24 compared to people who take placebo.

Conditions

  • Pulmonary Hypertension
  • Chronic Obstructive Pulmonary Disease

Eligibility

Eligible Ages
Between 40 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Double-blind

Arm Groups

ArmDescriptionAssigned Intervention
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).
  • Drug: MK-5475
    MK-5475 380 µg administered as dry powder inhalation once daily.
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).
  • Drug: MK-5475
    MK-5475 380 µg administered as dry powder inhalation once daily.
  • Drug: Placebo
    Placebo administered as dry powder inhalation once daily.

Recruiting Locations

The University of Texas Health Science Center at Houston ( Site 0105)
Houston, Texas 77030
Contact:
Study Coordinator
713-486-6159

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@merck.com