Frespaciguat (MK-5475) INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of Frespaciguat (an Inhaled sGC Stimulator) in Adults With PH-COPD
- Conditions
- Pulmonary HypertensionChronic Obstructive Pulmonary Disease
- Interventions
- Drug: FrespaciguatDrug: Placebo
- Registration Number
- NCT05612035
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Frespaciguat Frespaciguat Participants with PH-COPD will receive 380 µg of frespaciguat as an oral inhalation once daily for 24 weeks (base period) and thereafter for up to 42 months (optional extension period). Placebo Frespaciguat Participants with PH-COPD will receive matching placebo as an oral inhalation once daily for 24 weeks (base period) and then 380 µg of frespaciguat as an oral inhalation once daily for up to 42 months (optional extension period). Placebo 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 frespaciguat as an oral inhalation once daily for up to 42 months (optional extension period).
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24 Baseline and Week 24 6MWD is assessed using the 6-minute walk test (6MWT).
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in NT-ProBNP at Week 24 Baseline and Week 24 NT-proBNP was measured at baseline and Week 24
Percentage of Participants Whose World Health Organization-Functional Class (WHO-FC) Does not Worsen Relative to Baseline at Week 12 Baseline and Week 12 Participants are assigned one of four WHO-FC, dependent on limits of physical activity. As WHO-FC increases from I to IV, limits of physical activity increase.
Percentage of Participants Whose WHO-FC Does not Worsen Relative to Baseline at Week 24 Baseline and Week 24 Participants are assigned one of four WHO-FC, dependent on limits of physical activity. As WHO-FC increases from I to IV, limits of physical activity increase.
Percentage of Participants With One or More Adverse Events (AEs) Up to Week 206 An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Percentage of Participants who Discontinued Study Treatment due to an AE Up to Week 204 An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be presented.
Mean Change From Baseline in 6MWD at Week 12 Baseline and Week 12 6MWD is assessed using the 6-minute walk test (6MWT).
Mean Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) at Week 12 Baseline and Week 12 NT-proBNP was measured at baseline and Week 12.
Trial Locations
- 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
Scroll for more (74 remaining)UCSF Helen Diller Medical Center at Parnassus Heights ( Site 0110)🇺🇸San Francisco, California, United StatesStudy CoordinatorContact415-353-2296