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

April 5, 2024 updated by: Merck Sharp & Dohme LLC

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Recruiting
        • Fundación Respirar ( Site 0305)
        • Contact:
          • Study Coordinator
          • Phone Number: 01170781548
      • Cordoba, Argentina, X5016KEH
        • Recruiting
        • Hospital Privado Universitario de Córdoba-Clinical Cardiology Department ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: 5493516263892
    • Buenos Aires
      • La PLata, Buenos Aires, Argentina, 1904
        • Recruiting
        • Centro Medico Capital ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: 005492215317279
    • Tucuman
      • San Miguel de Tucumán, Tucuman, Argentina, 4000
        • Recruiting
        • Instituto de Cardiologia de Tucuman-Area de Investigacion Clinica ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: 54 0381 15 5339802
  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital-Department of Respiratory and Sleep Medicine ( Site 0902)
        • Contact:
          • Study Coordinator
          • Phone Number: +612 8890 6797
    • Queensland
      • Brisbane, Queensland, Australia, 4032
        • Recruiting
        • The Prince Charles Hospital ( Site 0904)
        • Contact:
          • Study Coordinator
          • Phone Number: +61738769033
      • South Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Mater Misericordiae Limited ( Site 0905)
        • Contact:
          • Study Coordinator
          • Phone Number: 61731632128
  • Austria
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Recruiting
        • Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: 4331638512183
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Recruiting
        • Medizinische Universitaet Innsbruck ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: +4366473410485
  • Belgium
    • Bruxelles-Capitale, Region De
      • Brussels, Bruxelles-Capitale, Region De, Belgium, 1070
        • Recruiting
        • Université Libre de Bruxelles - Hôpital Erasme ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: 0032475919898
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050034
        • Recruiting
        • Centro Cardiovascular Colombiano Clínica Santa María ( Site 0504)
        • Contact:
          • Study Coordinator
          • Phone Number: 573122957048
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 08001
        • Recruiting
        • Ciensalud Ips S A S ( Site 0508)
        • Contact:
          • Study Coordinator
          • Phone Number: 3108059885
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760036
        • Recruiting
        • Centro de Investigaciones Clinicas SAS ( Site 0505)
        • Contact:
          • Study Coordinator
          • Phone Number: 3162878747
      • Cali, Valle Del Cauca, Colombia, 760032
        • Recruiting
        • Fundación Valle del Lili ( Site 0509)
        • Contact:
          • Study Coordinator
          • Phone Number: 573155006300
  • France
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13915
        • Recruiting
        • C.H.U Hôpital Nord ( Site 1503)
        • Contact:
          • Study Coordinator
          • Phone Number: +33491966137
    • Paris
      • Le Kremlin-Bicêtre, Paris, France, 94270
        • Recruiting
        • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1501)
        • Contact:
          • Study Coordinator
          • Phone Number: +3345217976
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Recruiting
        • Centre Hospitalier Universitaire de Poitiers ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: 0549444444
  • Germany
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69126
        • Recruiting
        • Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 1603)
        • Contact:
          • Study Coordinator
          • Phone Number: 00496221 396 8053
    • Hessen
      • Gießen, Hessen, Germany, 35392
        • Recruiting
        • UKGM Gießen/Marburg ( Site 1604)
        • Contact:
          • Study Coordinator
          • Phone Number: 4964198557030
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: 495115323531
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1601)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 35145813981
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 1605)
        • Contact:
          • Study Coordinator
          • Phone Number: 4945150045000
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus ( Site 1701)
        • Contact:
          • Study Coordinator
          • Phone Number: +972548944992
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 1702)
        • Contact:
          • Study Coordinator
          • Phone Number: +97239377221
  • Italy
      • Palermo, Italy, 90127
        • Recruiting
        • ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ( Site 1804)
        • Contact:
          • Study Coordinator
          • Phone Number: 0912192111
    • Friuli-Venezia Giulia
      • Trieste, Friuli-Venezia Giulia, Italy, 34149
        • Recruiting
        • Cattinara Hospital ( Site 1801)
        • Contact:
          • Study Coordinator
          • Phone Number: +390403994665
    • Lombardia
      • Monza, Lombardia, Italy, 20900
        • Recruiting
        • Ospedale San Gerardo-ASST Monza-Cardio Vasolare- Clinica pneumologica ( Site 1802)
        • Contact:
          • Study Coordinator
          • Phone Number: +390392339245
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: 82220720243
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: 0230103994
    • Incheon
      • Namdong-gu, Incheon, Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Medical Center ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-10-3313-7129
  • Mexico
      • Mexico, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cardiologia Ignacio Chavez ( Site 0701)
        • Contact:
          • Study Coordinator
          • Phone Number: 5544429416
  • Peru
    • Lima
      • Cercado De Lima, Lima, Peru
        • Recruiting
        • Unidad de Investigacon de la Clinica Internacional ( Site 0804)
        • Contact:
          • Study Coordinator
          • Phone Number: 51 966804287
      • San Isidro, Lima, Peru, 15036
        • Recruiting
        • Clinica Ricardo Palma-Centro de Investigacion de Enfermedades Respiratorias Thorax ( Site 0806)
        • Contact:
          • Study Coordinator
          • Phone Number: 994615594
      • San Miguel, Lima, Peru, 15088
        • Recruiting
        • Clínica Providencia ( Site 0803)
        • Contact:
          • Study Coordinator
          • Phone Number: 996796096
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Recruiting
        • Netcare Milpark Hospital ( Site 2103)
        • Contact:
          • Study Coordinator
          • Phone Number: 0824569827
    • Kwazulu-Natal
      • Durban, Kwazulu-Natal, South Africa, 4001
        • Recruiting
        • Netcare St Augustine's Hospital ( Site 2105)
        • Contact:
          • Study Coordinator
          • Phone Number: 27312013899
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron ( Site 2002)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 932746157
      • Sevilla, Spain, 41013
        • Recruiting
        • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2005)
        • Contact:
          • Study Coordinator
          • Phone Number: 0034667956480
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla-Pneumology ( Site 2003)
        • Contact:
          • Study Coordinator
          • Phone Number: 34 942 20 35 65
    • Cataluna
      • Barcelona, Cataluna, Spain, 08036
        • Recruiting
        • HOSPITAL CLÍNIC DE BARCELONA ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: 34 932275779
  • Switzerland
      • Sankt Gallen, Switzerland, 9007
        • Recruiting
        • Cantonal Hospital St.Gallen ( Site 2203)
        • Contact:
          • Study Coordinator
          • Phone Number: 43714943692
    • Zurich
      • Zürich, Zurich, Switzerland, 8091
        • Recruiting
        • UniversitätsSpital Zürich ( Site 2201)
        • Contact:
          • Study Coordinator
          • Phone Number: +41797962829
  • Turkey
      • Ankara, Turkey, 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri ( Site 2301)
        • Contact:
          • Study Coordinator
          • Phone Number: 905337787260
      • Ankara, Turkey, 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi. ( Site 2307)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 312 552 6 000
      • Eskisehir, Turkey, 26480
        • Recruiting
        • Eskisehir Osmangazi University-Cardiology ( Site 2304)
        • Contact:
          • Study Coordinator
          • Phone Number: 905332337849
      • Istanbul, Turkey, 34093
        • Recruiting
        • Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi-Chest Disease ( Site 2302)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 532 283 17 26
  • United Kingdom
      • Sheffield, United Kingdom, S10 2JF
        • Recruiting
        • Sheffield Teaching Hospitals NHS Foundation Trust-Clinical Research Facility ( Site 2405)
        • Contact:
          • Study Coordinator
          • Phone Number: 01142712132
    • London, City Of
      • London, London, City Of, United Kingdom, W12 OHS
        • Recruiting
        • Hammersmith Hospital-Department of Cardiology ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: 07701040851
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular
        • Contact:
          • Study Coordinator
          • Phone Number: 720-848-0000
    • Florida
      • Sebring, Florida, United States, 33870
        • Completed
        • Clinovation Intl. Corp. ( Site 0108)
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Recruiting
        • Alexian Brothers Medical Center-Pulmonary ( Site 0109)
        • Contact:
          • Study Coordinator
          • Phone Number: 224-273-2387
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa ( Site 0103)
        • Contact:
          • Study Coordinator
          • Phone Number: 319-353-5236
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center-IM-Pulmonary and Critical Care Medicine ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: 913-588-6045
    • Kentucky
      • Lexington, Kentucky, United States, 40502
        • Recruiting
        • Lexington VA Medical Center - Cooper Division ( Site 0137)
        • Contact:
          • Study Coordinator
          • Phone Number: 859-233-4511
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester, Minnesota ( Site 0131)
        • Contact:
          • Study Coordinator
          • Phone Number: 800-752-1606
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Completed
        • Creighton University Clinical Research Office ( Site 0123)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University Hospital ( Site 0104)
        • Contact:
          • Study Coordinator
          • Phone Number: 215-707-1359
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center ( Site 0114)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-645-5505
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston ( Site 0105)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-486-6159
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center-Division of Pulmonary & Critical Care Medicine ( Site 0140)
        • Contact:
          • Study Coordinator
          • Phone Number: 702-852-9000
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Health System-Division of Pulmonary and Critical Care Medicine ( Site 0111)
        • Contact:
          • Study Coordinator
          • Phone Number: 434-243-6074

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24
Time Frame: Baseline and Week 24
6MWD is assessed using the 6-minute walk test (6MWT).
Baseline and Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in 6MWD at Week 12
Time Frame: Baseline and Week 12
6MWD is assessed using the 6-minute walk test (6MWT).
Baseline and Week 12
Mean Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) at Week 12
Time Frame: Baseline and Week 12
NT-proBNP was measured at baseline and Week 12.
Baseline and Week 12
Mean Change From Baseline in NT-ProBNP at Week 24
Time Frame: Baseline and Week 24
NT-proBNP was measured at baseline and Week 24
Baseline and Week 24
Percentage of Participants Whose World Health Organization-Functional Class (WHO-FC) Does not Worsen Relative to Baseline at Week 12
Time Frame: 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.
Baseline and Week 12
Percentage of Participants Whose WHO-FC Does not Worsen Relative to Baseline at Week 24
Time Frame: 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.
Baseline and Week 24
Percentage of Participants With One or More Adverse Events (AEs)
Time Frame: Up to Week 104
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.
Up to Week 104
Percentage of Participants who Discontinued Study Treatment due to an AE
Time Frame: Up to Week 102
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.
Up to Week 102

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2023

Primary Completion (Estimated)

April 7, 2026

Study Completion (Estimated)

March 23, 2028

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5475-013
  • MK-5475-013 (Other Identifier: Merck)
  • 2022-501201-13-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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